Leukemia is a cancer of the early blood-forming cells. Most often, leukemia is a cancer of the white blood cells, but some leukemias start in other blood cell types. Leukemia is often described as being either acute (fast growing) or chronic (slow growing). Different types of leukemia have different treatment options and outlooks.

Click the links below to view the clinical trials available.

A 1-Year, Multicenter, Randomized, Open-Label Controlled Study to Evaluate the Efficacy and Safety of Cord Blood Cells Expanded With MPCs for Hematopoetic Recovery in Patients With Hematologic Malignancies After Myeloablative Treatment

  • Purpose: The study investigates the time to engraftment of a mesenchymal expanded cord blood unit in patients with hematologic malignancies undergoing transplantation with myeloablative conditioning.
  • Eligibility: Age 0-65, male or female. Patient must have one of the following: acute myelogenous leukemia (AML) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable), acute lymphoblastic leukemia (ALL) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable), Non-Hodgkin's lymphoma (NHL): High risk subjects with responsive disease after first relapse. High risk includes those with Burkitt's Lymphoma and those with extensive marrow involvement at diagnosis-precluding autologous transplant, Hodgkin's disease: High risk subjects with responsive disease after first relapse. Minimum Karnofsky Scale. Subject must weigh at least 20 kg. Adequate major organ system function.
  • Exclusion Criteria: Pregnancy and/or lactating, suitable, 6/6 HLA matched related sibling donor available, previous participation in a stem cell study within last 30 days.

Contact:
Principal Investigator: Paul Shaughnessy, MD
Research Coordinator: (210) 575-3161

Principal Investigator: Robert Sanders, MD
Research Coordinator: (210) 524-4400

For more information on this trial, visit ClinicalTrials.gov.


The Role of Minimal Residual Disease Testing Before and After Hematopoietic Cell Transplantation for Pediatric Acute Myeloid Leukemia

  • Purpose: This is a non-therapeutic study. Pediatric AML patients undergoing HCT with a myeloablative preparative regimen may be enrolled. Subjects can be enrolled 10-40 days prior to HCT. Three samples for MRD (measured by WT1 PCR and flow cytometry) will be collected from peripheral blood and bone marrow: 1) pre-HCT (< 3 weeks prior to starting the preparative regimen), 2) day 42 +/- 14 days post HCT (early post-engraftment), and 3) day 100 (+/-20 days) post HCT. For two years after transplant, the subject's follow-up data will be collected using the Research Level Forms in the CIBMTR Forms Net internet data entry system. The main objective is to determine whether there is any association between level of pre-transplant and post-transplant bone marrow MRD using WT1 and flow cytometry with 2-year event-free-survival, and to estimate the strength of that association in terms of the predictive accuracy of MRD. The investigators hypothesize that measurable MRD at either time point will be associated with decreased 2-year event-free survival.
  • Eligibility: Subject or legal guardian to understand and voluntarily sign an informed consent. Age 0-21 at time of transplant, male or female.
  • Exclusion Criteria: Women who are pregnant (positive HCG) or breastfeeding. Evidence of HIV infection or HIV positive serology. Positive viral load (PCR) for Hepatitis B or C. Current uncontrolled bacterial, viral or fungal infection (currently taking medication and progression of clinical symptoms). Autologous transplant < 12 months prior to enrollment. Prior allogeneic hematopoietic stem cell transplant.

Contact:
Principal Investigator: Paul Shaughnessy, MD
Research Coordinator: (210) 575-3161

Principal Investigator: Robert Sanders, MD
Research Coordinator: (210) 524-4400

For more information on this trial, visit ClinicalTrials.gov.


A Children's Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens

  • Purpose: This research study is collecting and storing samples of bone marrow and blood from patients with relapsed acute lymphoblastic leukemia or relapsed non-Hodgkin lymphoma.
  • Eligibility: Age up to 30 years old. Diagnosis of acute lymphoblastic leukemia (ALL) or prior history of non-Hodgkin lymphoma. In first or subsequent marrow relapse with ≥ 25% blasts in bone marrow and/or peripheral blood. Bone marrow and/or peripheral blood samples (≥ 5 mL) required at the time of diagnosis of relapse.
  • Exclusion Criteria: Diagnosis of acute lymphoblastic leukemia (ALL) or prior history of non-Hodgkin lymphoma. In first or subsequent marrow relapse with ≥ 25% blasts in bone marrow and/or peripheral blood. Bone marrow and/or peripheral blood samples (≥ 5 mL) required at the time of diagnosis of relapse.

Contact:
Principal Investigator: Jaime Estrada, MD
Research Coordinator: (210) 575-3161

For more information on this trial, visit ClinicalTrials.gov.


Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

  • Purpose: This research trial studies a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia. Gathering health information about patients with acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment.
  • Eligibility: Age up to 30, male or female. Patient has newly diagnosed acute leukemia: > 25% blasts on a bone marrow (BM) aspirate or if a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy or a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic blasts.

Contact:
Principal Investigator: Jaime Estrada, MD
Research Coordinator: (210) 575-3161

For more information on this trial, visit ClinicalTrials.gov.


Intensified Methotrexate, Nelarabine (Compound 506U78) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) or T-Cell Lymphoblastic Lymphoma

  • Purpose: This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
  • Eligibility: Age 1-30, male or female. T-ALL patients must be enrolled on AALL08B1 prior to treatment and enrollment on AALL0434. Patients must have newly diagnosed T-ALL or T-lineage lymphoblastic lymphoma (T-NHL) stage II-IV; B-lineage lymphoblastic lymphoma will not be eligible for this study; a diagnosis of T-ALL is established when leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation (cluster of differentiation [CD]19/CD22/CD20), and express either surface or cytoplasmic CD3 or two or more of the antigens CD8, CD7, CD5, CD4, CD2 or CD1a; if surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including transmission disequilibrium test (TdT), CD34 or CD99 will be assessed for expression; cases with uncertain expression will receive additional review within the appropriate Children's Oncology Group (COG) reference laboratory.
  • Exclusion Criteria: Pregnant or lactating females are ineligible. Patients with Down syndrome are ineligible to enroll onto this study. For T-NHL patients the following additional exclusion criteria apply: B-precursor lymphoblastic lymphoma, Morphologically unclassifiable lymphoma, absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma, CNS3-positive or testicular involvement.

Contact:
Principal Investigator: Jaime Estrada, MD
Research Coordinator: (210) 575-3161

For more information on this trial, visit ClinicalTrials.gov.


A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum

  • Purpose: This randomized phase III trial is studying how well combination chemotherapy works in treating young patients with newly diagnosed high-risk acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.
  • Eligibility: Age 1-30, male or female. Patients must have newly diagnosed B lymphoblastic leukemia (2008 WHO classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible. Eligibility criteria for the Incidence and Natural History of Osteonecrosis study.
  • Exclusion Criteria: With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131.

Contact:
Principal Investigator: Jaime Estrada, MD
Research Coordinator: (210) 575-3161

For more information on this trial, visit ClinicalTrials.gov.

A Phase II, Randomized, Comparative Trial of Standard of Care, With or Without Midostaruin to Prevent Relapse Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With FLT3-ITD Mutated Acute Myeloid Leukemia

  • Purpose: To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant
  • Eligibility: Age 18-60, male or female. Patients must have an ECOG Performance Status of < 2. Patients must have a documented Unequivocal diagnosis of AML according to WHO 2008 classification (>20% blasts in the bone marrow), excluding M3 (acute promyelocytic leukemia). Patients must have a documented FLT3 ITD mutation, determined by local laboratory for eligibility (historical tissue will be requested for central analysis confirmation) Patients who have undergone allogeneic HSCT in CR1 from a matched related or matched unrelated donor.
  • Exclusion Criteria: Patients whom have failed prior attempts at allogeneic HSCT, patients who have received an autologous transplant, patients with Acute GVHD Grade III-IV, patients with a known confirmed diagnosis of HIV infection or active viral hepatitis. Patients with impaired cardiac function. Pregnant or nursing (lactating) women, or women of child-bearing potential, must use highly effective methods of contraception during dosing and for 30 days after treatment completion.

Contact:
Principal Investigator: Carlos Bachier, MD
Research Coordinator: (210) 575-3161

For more information on this trial, visit ClinicalTrials.gov.


A 1-Year, Multicenter, Randomized, Open-Label Controlled Study to Evaluate the Efficacy and Safety of Cord Blood Cells Expanded With MPCs for Hematopoetic Recovery in Patients With Hematologic Malignancies After Myeloablative Treatment

  • Purpose: The study investigates the time to engraftment of a mesenchymal expanded cord blood unit in patients with hematologic malignancies undergoing transplantation with myeloablative conditioning.
  • Eligibility: Age 0-65, male or female. Patient must have one of the following: acute myelogenous leukemia (AML) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable), acute lymphoblastic leukemia (ALL) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable), Non-Hodgkin's lymphoma (NHL): High risk subjects with responsive disease after first relapse. High risk includes those with Burkitt's Lymphoma and those with extensive marrow involvement at diagnosis-precluding autologous transplant, Hodgkin's disease: High risk subjects with responsive disease after first relapse. Minimum Karnofsky Scale. Subject must weigh at least 20 kg. Adequate major organ system function.
  • Exclusion Criteria: Pregnancy and/or lactating, suitable, 6/6 HLA matched related sibling donor available, previous participation in a stem cell study within last 30 days.

Contact:
Principal Investigator: Paul Shaughnessy, MD
Research Coordinator: (210) 575-3161

Principal Investigator: Robert Sanders, MD
Research Coordinator: (210) 524-4400

For more information on this trial, visit ClinicalTrials.gov.


A Randomized Phase II Study Comparing Two Different Conditioning Regimens Prior to Allogeneic Hematopoietic Cell Transplantation (HCT) for Children With Juvenile Myelomonocytic Leukemia (JMML)

  • Purpose: This randomized phase II trial studies how well giving busulfan, cyclophosphamide, and melphalan or busulfan and fludarabine phosphate before donor hematopoietic cell transplant works in treating younger patients with juvenile myelomonocytic leukemia. Giving chemotherapy before a donor hematopoietic transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known whether giving busulfan, cyclophosphamide, and melphalan or busulfan and fludarabine phosphate before a donor stem cell transplant is more effective in treating juvenile myelomonocytic leukemia.
  • Eligibility: Age 3-18, male or female. Patients must have a strong clinical suspicion of JMML, based on a modified category 1 of the revised diagnostic criteria.
  • Exclusion Criteria: Patients with a known germline mutation of Noonan's Syndrome (PTPN11) are not eligible. Patients with a history of Neurofibromatosis type 1 (NF1) and either. A history of a tumor of the central nervous system (astrocytoma or optic glioma), or a malignant peripheral nerve sheath tumor with a complete remission of < 1 year are not eligible.

Contact:
Principal Investigator: Robert Sanders, MD
Research Coordinator: (210) 524-4400

For more information on this trial, visit ClinicalTrials.gov.


KIR Genotyping for Unrelated Donor (URD) Selection Prior to Hematopoietic Cell Transplantation (HCT) for AML: Selecting a Favorable KIR Donor

  • Purpose: Donors with favorable KIR B haplotype gene content have yielded reduced relapse risk and improved leukemia free survival (LFS) in retrospective analyses of unrelated donor (URD) hematopoietic cell transplantation (HCT) for acute myelogenous leukemia (AML). Specifically, donors with more KIR B gene content and those who are homozygous for the centromeric (Cen) B haplotype genes (as opposed to the telomeric (Tel) genes confer the most protective effect. This study proposes to prospectively test and validate the utility and effectiveness of further informing URD identification and selection by KIR genotyping as a supplement to HLA matching and the other variables known or suspected to indicate the best URD for a patient.
  • Eligibility: Male or female. Patient with acute myeloid leukemia (AML) undergoing screening for potential URD HCT. Potential URD undergoing screening to provide a HCT graft to a patient with acute myeloid leukemia (AML) at a participating institution. Provides written consent.
  • Exclusion Criteria: Transplant Centers will select the best HLA matched, and as appropriate, preferred KIR donor. In situations where the preferred (best > better > neutral) KIR donor is not selected in favor of a less favorable KIR genotype donor, the center will report one or more defined reasons (donor age; gender; parity; CMV status; ABO status; availability/logistics; other) for the choice (among equivalently HLA matched donors).

Contact:
Principal Investigator: Robert Sanders, MD
Research Coordinator: (210) 524-4400

Principal Investigator: Carlos Bachier, MD
Research Coordinator: (210) 575-3161

For more information on this trial, visit ClinicalTrials.gov.


A Phase III Randomized Trial for Patients With De Novo AML Using Bortezomib and Sorafenib ( NSC# 681239, NSC# 724772) for Patients With High Allelic Ratio FLT3/ITD

  • Purpose: This randomized phase III trial studies how well bortezomib and sorafenib tosylate work in treating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib and sorafenib tosylate together with combination chemotherapy may be an effective treatment for acute myeloid leukemia.
  • Eligibility: Age less than 30, male or female. Patients must be newly diagnosed with de novo acute myelogenous leukemia. Patients with previously untreated primary AML who meet the customary criteria for AML with >= 20% bone marrow blasts as set out in the 2008 World Health Organization (WHO) Myeloid Neoplasm Classification are eligible.
  • Exclusion Criteria: Patients with any of the following constitutional conditions are not eligible: Fanconi anemia, Shwachman syndrome, Any other known bone marrow failure syndrome.

Contact:
Principal Investigator: Jaime Estrada, MD
Research Coordinator: (210) 575-3161

For more information on this trial, visit ClinicalTrials.gov.


Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children with Cancer

  • Purpose: This research trial studies neuropsychological (learning, remembering or thinking) and behavioral testing in younger patients with cancer. Collecting information over time from a series of tests may help doctors develop effective tests to measure neuropsychological and behavioral function of patients with cancer.
  • Eligibility: Age one month to 21 years, male or female. The patient must be currently be enrolled or plan to be enrolled on a COG therapeutic study that aims to examine neuropsychological, social, emotional, and/or behavioral functioning. The patient must have receptive and expressive English language skills.
  • Exclusion Criteria: Patients with a history of severe or profound mental retardation (i.e. intelligence quotient [IQ] =< 50) are not eligible for enrollment; PLEASE NOTE: Children with a prior history of attention deficit hyperactivity disorder (ADHD) or a specific learning disability (e.g. dyslexia) are eligible for this study.

For more information on this trial, visit ClinicalTrials.gov.


Longitudinal Assessment of Ovarian Reserve in Adolescents with Lymphoma

  • Purpose: This clinical trial studies blood sample markers of reproductive hormones in assessing ovarian reserve in younger patients with newly diagnosed lymphomas. Studying samples of blood from patients with cancer in the laboratory may help measure the effect of curative therapy for lymphoma on ovarian failure.
  • Eligibility: Age up to 29 years, female only. Patients must have had first menses >= 6 months prior to enrollment. Patients must be newly diagnosed with lymphoma; this includes but is not limited to Hodgkin lymphoma, Burkitts lymphoma, diffuse large B cell lymphoma, and anaplastic large cell lymphoma. Planned cancer treatment must include an alkylating agent: i.e. procarbazine, cyclophosphamide, ifosphamide; planned cancer treatment must be less than one year.
  • Exclusion Criteria: Patients who have previously received chemotherapy other than steroids and intrathecal chemotherapy are not eligible. Patients who have a secondary malignancy are not eligible.

Contact:
Principal Investigator: Jaime Estrada, MD
Research Coordinator: (210) 575-3161

For more information on this trial, visit ClinicalTrials.gov.


Neuroblastoma Biology Studies

  • Purpose: This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
  • Eligibility: Age up to 30 years, male or female. All newly diagnosed patients with suspected neuroblastoma, suspected ganglioneuroblastoma, or suspected ganglioneuroma/maturing subtype seen at Children's Oncology Group (COG) institutions are eligible for this study. There will be no penalty under any circumstances for enrollment of a patient whose definitive institutional diagnosis, or central review diagnosis, is found to be a tumor other than neuroblastoma, ganglioneuroblastoma, or ganglioneuroma/ maturing subtype.
  • Exclusion Criteria: Patients with relapsed neuroblastoma who were not enrolled on ANBL00B1 at original diagnosis are NOT eligible; samples should be submitted as part of the ABTR04B1 protocol.

Contact:
Principal Investigator: Jaime Estrada, MD
Research Coordinator: (210) 575-3161

For more information on this trial, visit ClinicalTrials.gov.


Pilot Study Using Myeloablative Busulfan/Melphalan (BuMel) Consolidation Following Induction Chemotherapy for Patients With Newly Diagnosed High-Risk Neuroblastoma

  • Purpose: This pilot clinical trial studies busulfan, melphalan, and stem cell transplant after chemotherapy in treating patients with newly diagnosed neuroblastoma. Giving chemotherapy to the entire body before a stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
  • Eligibility: Patients must have a diagnosis of neuroblastoma (International Classification of Diseases for Oncology [ICD-O] morphology 9500/3) or ganglioneuroblastoma (nodular or intermixed) verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites; patients with the following disease stages at diagnosis are eligible, if they meet the other specified criteria.
  • Exclusion Criteria: Patients that are 12-18 months of age with INSS stage 4 and all 3 favorable biologic features (ie, nonamplified MYCN, favorable pathology, and DNA index > 1) are not eligible. Female patients who are pregnant are ineligible. Lactating females are not eligible unless they have agreed not to breastfeed their infants. Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained. Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation.

Contact:
Principal Investigator: Jaime Estrada, MD
Research Coordinator: (210) 575-3161

For more information on this trial, visit ClinicalTrials.gov.


Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue

  • Purpose: This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as dinutuximab, may block tumor growth in different ways by targeting certain cells. Aldesleukin and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating neuroblastoma.
  • Eligibility: All patients must be diagnosed with neuroblastoma, and categorized as high risk at the time of diagnosis; exception: patients who are initially diagnosed as non-high-risk neuroblastoma, but later converted (and/or relapsed) to high risk neuroblastoma are also eligible.

Contact:
Principal Investigator: Jaime Estrada, MD
Research Coordinator: (210) 575-3161

For more information on this trial, visit ClinicalTrials.gov.


Rare And Cutaneous Non-Hodgkin Lymphoma Registry

  • Purpose: This research study is collecting and storing tissue samples from patients with rare or cutaneous non-Hodgkin lymphoma.
  • Eligibility: Age up to 21 years, male or female. DISEASE CHARACTERISTICS: Diagnosis of non-Hodgkin lymphoma (NHL). Any histology, except for Burkitt or Burkitt-like, diffuse large B-cell, anaplastic large cell, or lymphoblastic lymphoma. Primary CNS, primary cutaneous NHL, or lymphoproliferative diseases of any histology allowed. Pathological specimen from site not treated within the past 6 months. Must have specimens available.

Contact:
Principal Investigator: Jaime Estrada, MD
Research Coordinator: (210) 575-3161

For more information on this trial, visit ClinicalTrials.gov.


A Phase 1/2, Dose and Schedule Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Oral Azacitidine (CC-486) in Subjects With Acute Myeloid Leukemia or Myelodysplastic Syndromes After Allogeneic Hematopoietic Stem Cell Transplantation

  • Purpose: The purpose of the study is to determine the maximal tolerated dose and schedule of CC-486 (also known as oral Azacitidine) in patients with AML or MDS after allogeneic HSCT. Allogeneic hematopoietic stem cell transplantation (HSCT) is more frequently used in Acute Myloid leukemia (AML) or Myelodysplastic Syndromes (MDS) as a potential curative therapy. However, disease recurrence/relapse and graft-versus-host disease (GVHD) remain the principal causes of fatal complications after transplantation. Azacitidine has significant activity in MDS and AML. Azacitidine has also demonstrated immunomodulatory activity in AML patients after allogeneic HSCT. An oral formulation of Azacitidine provides a convenient route of administration and an opportunity to deliver the drug over a prolonged schedule.
  • Eligibility: Age 18 and older, male or female. Histologically confirmed (Myelodysplastic Syndromes) MDS or Acute Myeloid Leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (HSCT) with either peripheral blood or bone marrow as the source of hematopoietic stem cells.
  • Exclusion Criteria: Use of any of the following after transplantation and prior to starting oral Azacitidine: Chemotherapeutic agents for chemotherapy, Investigational agents/therapies, Azacitidine, decitabine or other demethylating agents, Lenalidomide, thalidomide and pomalidomide, Active Graft-versus-host disease (GVHD) grade II or higher, Any evidence of gastrointestinal (GI) GVHD, Concurrent use of corticosteroids equivalent of prednisone at a dose > 0.5 mg/kg, Known active viral infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV), Active uncontrolled systemic fungal, bacterial or viral infection, Presence of malignancies, other than MDS or AML, within the previous 12 months, Significant active cardiac disease within the previous 6 months.

Contact:
Principal Investigator: Carlos Bachier, MD
Research Coordinator: (210) 575-3161

For more information on this trial, visit ClinicalTrials.gov.

A 1-Year, Multicenter, Randomized, Open-Label Controlled Study to Evaluate the Efficacy and Safety of Cord Blood Cells Expanded With MPCs for Hematopoetic Recovery in Patients With Hematologic Malignancies After Myeloablative Treatment

  • Purpose: The study investigates the time to engraftment of a mesenchymal expanded cord blood unit in patients with hematologic malignancies undergoing transplantation with myeloablative conditioning.
  • Eligibility: Age 0-65, male or female. Patient must have one of the following: acute myelogenous leukemia (AML) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable), acute lymphoblastic leukemia (ALL) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable), Non-Hodgkin's lymphoma (NHL): High risk subjects with responsive disease after first relapse. High risk includes those with Burkitt's Lymphoma and those with extensive marrow involvement at diagnosis-precluding autologous transplant, Hodgkin's disease: High risk subjects with responsive disease after first relapse. Minimum Karnofsky Scale. Subject must weigh at least 20 kg. Adequate major organ system function.
  • Exclusion Criteria: Pregnancy and/or lactating, suitable, 6/6 HLA matched related sibling donor available, previous participation in a stem cell study within last 30 days.

Contact:
Principal Investigator: Robert Sanders, MD
Research Coordinator: (210) 524-4400

For more information on this trial, visit ClinicalTrials.gov.


Allogeneic Hematopoietic Cell Transplant for Hematological Cancers and Myelodysplastic Syndromes in HIV-Infected Individuals

  • Purpose: The rationale for this trial is to demonstrate the feasibility and safety of allogeneic HCT for patients with chemotherapy-sensitive hematological malignancies and coincident HIV-infection. In particular, the trial will focus on the 100-day non-relapse mortality as an indicator of the safety of transplant in this patient population. Correlative assays will focus upon the incidence of infectious complications in this patient population, the evolution of HIV infection and immunological reconstitution. Where feasible (and when this can be accomplished without compromise of either the donor quality or the timeliness of transplantation), an attempt will be made to identify donors who are homozygotes for the delta32 mutation for CCR5.
  • Eligibility: HIV-1 infection, as documented by a rapid HIV test or any FDA-Approved HIV-1 Enzyme or Chemiluminescence Immunoassay (E/CIA) test kit and confirmed by Western Blot at any time prior to study entry. HIV antigen, plasma HIV-1 RNA, or a secondary antibody test by a method other than rapid HIV and E/CIA is acceptable as an alternative test. Alternatively, if a rapid HIV test or any FDA-Approved HIV-1 Enzyme or Chemiluminescence Immunoassay (E/CIA) test is not available, two HIV-1 RNA values greater than or equal to 2000 copies/mL at least 24 hours apart performed by any laboratory that has CLIA certification, or its equivalent, may be used to document infection.
  • Exclusion Criteria: Karnofsky/Lansky performance score less than 70 percent. Active CNS malignancy; however, patients with a history of positive CSF cytology that has become negative with intrathecal chemotherapy are eligible. Uncontrolled bacterial, viral or fungal infection (currently taking medication and with progression or no clinical improvement). Active CMV retinitis or other CMV-related organ dysfunction. AIDS related syndromes or symptoms that pose a perceived excessive risk for transplantation-related morbidity as determined by the principal investigator.

Contact:
Principal Investigator: Paul Shaughnessy, MD
Research Coordinator: (210) 575-4281

For more information on this trial, visit ClinicalTrials.gov.

A 1-Year, Multicenter, Randomized, Open-Label Controlled Study to Evaluate the Efficacy and Safety of Cord Blood Cells Expanded With MPCs for Hematopoetic Recovery in Patients With Hematologic Malignancies After Myeloablative Treatment

  • Purpose: The study investigates the time to engraftment of a mesenchymal expanded cord blood unit in patients with hematologic malignancies undergoing transplantation with myeloablative conditioning.
  • Eligibility: Age 0-65, male or female. Patient must have one of the following: acute myelogenous leukemia (AML) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable), acute lymphoblastic leukemia (ALL) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable), Non-Hodgkin's lymphoma (NHL): High risk subjects with responsive disease after first relapse. High risk includes those with Burkitt's Lymphoma and those with extensive marrow involvement at diagnosis-precluding autologous transplant, Hodgkin's disease: High risk subjects with responsive disease after first relapse. Minimum Karnofsky Scale. Subject must weigh at least 20 kg. Adequate major organ system function.
  • Exclusion Criteria: Pregnancy and/or lactating, suitable, 6/6 HLA matched related sibling donor available, previous participation in a stem cell study within last 30 days.

Contact:
Principal Investigator: Robert Sanders, MD
Research Coordinator: (210) 524-4400

For more information on this trial, visit ClinicalTrials.gov.


A Randomized Open-Label Trial of Caspofungin Versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML)

  • Purpose: This randomized phase III trial studies caspofungin acetate to see how it works compared to fluconazole in preventing invasive fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy. Caspofungin acetate or fluconazole may help prevent fungal infections caused by chemotherapy. It is not yet known whether fluconazole is more effective than caspofungin acetate in preventing fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy.
  • Eligibility: Patients must have one of the following diagnoses and/or treatment plans: Newly diagnosed de novo AML, First or subsequent relapse of AML, Secondary AML, Treatment with institutional standard AML therapy in those without AML (for example, myelodysplastic syndrome, bone marrow blasts > 5% or biphenotypia).
  • Exclusion Criteria: Patients with the following diagnoses are not eligible: Acute promyelocytic leukemia (APL), Down syndrome, Juvenile myelomonocytic leukemia (JMML).

Contact:
Principal Investigator: Jaime Estrada, MD
Research Coordinator: (210) 575-3161

For more information on this trial, visit ClinicalTrials.gov.


A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT)

  • Purpose: This randomized phase III trial studies how well levofloxacin works in preventing infection in young patients with acute leukemia receiving chemotherapy or undergoing stem cell transplant. Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia. It is not yet known whether levofloxacin is effective in preventing infection.
  • Eligibility: Age 6 months- 21 years, male or female. Patient must fit 1 of the following 2 categories: Chemotherapy patients, Planned to receive at least 2 consecutive cycles (not required to be the first 2 cycles) of intensive chemotherapy for either: De novo, relapsed or secondary acute myeloid leukemia (AML), or acute leukemia of ambiguous lineage treated with standard AML therapy. Relapsed acute lymphoblastic leukemia (ALL).
  • Exclusion Criteria: Patients previously enrolled on the trial are not eligible; therefore, patients with AL who were on study during intensive chemotherapy are not eligible to be enrolled during the HSCT. Patients with an allergy to quinolones. Patients with chronic active arthritis. Patients with a known pathologic prolongation of the corrected QT (QTc). Females who are pregnant or breast feeding.

Contact:
Principal Investigator: Jaime Estrada, MD
Research Coordinator: (210) 575-3161

For more information on this trial, visit ClinicalTrials.gov.


A Phase III Open-Label Trial of Caspofungin vs. Azole Prophylaxis for Patients at High-Risk for Invasive Fungal Infections (IFI) Following Allogeneic Hematopoietic Cell Transplantation (HCT)

  • Purpose: This randomized phase III trial studies how well caspofungin acetate works compared to fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant. Caspofungin acetate, fluconazole, and voriconazole may be effective in preventing fungal infections in patients following donor stem cell transplant. It is not yet known whether caspofungin acetate is more effective than fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant.
  • Eligibility: Age 3 months – 20 years, male or female. The patient must be undergoing allogeneic HCT from any donor (including matched related) with any stem cell source for any underlying condition.
  • Exclusion Criteria: Within 90 days of enrollment: Patients with a proven or probable invasive mold infection are not eligible. Patients with an incompletely treated invasive yeast infection are not eligible.

Contact:
Principal Investigator: Jaime Estrada, MD
Research Coordinator: (210) 575-3161

For more information on this trial, visit ClinicalTrials.gov.