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The Methodist transplant team is committed to bringing you new and innovative investigational cancer treatment options.

One way we do this is by participating in cancer research trials and studies. Clinical trials provide patients with either the best treatment currently available or a new and possibly more effective therapy.

We encourage you to discuss your treatment options including research trials with your transplant doctor.

Clinical trials are available for all stages of cancer, at MHS we offer clinical trials for:

Medical Management

AML

Biological assessment of blood, marrow and solid tumors in patients with malignant disorders

  • Population: Adult, 18 years and older
  • Status: Open
  • Contact: 210-643-7218
  • Principal Investigator: Paul Shaughnessy, MD

SCRI AML 16: A phase 1B open label, dose escalation study of MLN4929 plus Azacytidine in treatment-naïve patients with AML who are 60 years and older

  • Population: Adult, 60 years and older
  • Status: Open
  • Contact: 210-241-0266
  • Principal Investigator: Jose Cruz, MD
  • For the most up to date information, visit clinicaltrials.gov

SCRI AML 22: A Phase 1 Study of ASP2215 in Combination with Induction and Consolidation Chemotherapy in Patients with Newly Diagnosed AML

  • Population: Adult, 18 years and older
  • Status: Open
  • Contact: 210-241-0266
  • Principal Investigator: Jose Cruz, MD
  • For the most up to date information, visit clinicaltrials.gov

SCRI AML 24: A Phase III, Global, Double-Blinded, Placebo-controlled, Multicenter, Randomized Study of Pracinostat in combination with Azacitidine (AZA) in Patients >60 Years with Newly diagnosed Acute Myeloid Leukemia (AML)

  • Population: Adult, 60 years and older
  • Status: Pending
  • Contact: 210-241-0266
  • Principal Investigator: Jose Cruz, MD

SCRI Seattle Genetics: A randomized, double-blind phase 3 study of SGN-CD33A (vadastuximab talirine) or placebo in combination with azacitidine or decitabine in the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible or unfit for treatment with intensive induction chemotherapy

  • Population: Adult, 18 years and older
  • Status: Pending
  • Contact: 210-241-0266
  • Principal Investigator: Jose Cruz, MD

SCRI AML 27: Stemline Therapeutics: A Phase 1/2 study of SL-401 as consolidation therapy for adult patients with adverse risk AML in first CR and/or evideence of MRD in first CR

  • Population: Adult, 18 years and older
  • Status: Pending
  • Contact: 210-241-0266
  • Principal Investigator: Jose Cruz, MD
  • For the most up to date information, visit clinicaltrials.gov

AAML1031: A Phase III Randomized Trial for Patients with de novo AML using Bortezomib and Sorafenib for Patients with High Allelic Ratio FLT3/ITD

  • Population: Adult/Pediatric, less than 30 years old
  • Status: Open
  • Contact: 210-325-3803
  • Principal Investigator: Jaime Estrada, MD
  • For the most up to date information, visit clinicaltrials.gov

SCRI AML 15: A Phase III, Randomized, Double Blind, Placebo Controlled Study to Compare Efficacy and Safety of Oral Azacytidine plus Best Supportive Care versus Best Supportive Care as Maintenance Therapy in Subjects with AML in CR

  • Population: Adult, 18 years and older
  • Status: Open
  • Contact: 210-241-0266
  • Principal Investigator: Jose Cruz, MD
  • For the most up to date information, visit clinicaltrials.gov

SCRI AML 21: (KCP) Randomized, Open Label, Phase 2 of the Selective Inhibitor of the Nuclear Expor (ISONE) Selinexor (KPT 330) versus Specified Physician's Choice in Patients 60 year old with relapsed/refractory AML who are ineligible for intense chemotherapy

  • Population: Adult, 60 years and older
  • Status: Hold
  • Contact: 210-241-0266
  • Principal Investigator: Jose Cruz, MD
  • For the most up to date information, visit clinicaltrials.gov

SCRI AML 26: Giliad, Phase 1b/2 Study of Entospletinib (GS-9973) Monotherapy and in Combination with Chemotherapy in Subjects with Acute Myeloid Leukemia (AML)

  • Population: Adult
  • Status: Pending
  • Contact: 210-241-0266
  • Principal Investigator: Jose Cruz, MD
  • For the most up to date information, visit clinicaltrials.gov

Biological assessment of blood, marrow and solid tumors in patients with malignant disorders

  • Population: Adult, 18 years and older
  • Status: Open
  • Contact: 210-643-7218
  • Principal Investigator: Paul Shaughnessy, MD

AALL05B1: A Children's Oncology Group Protocol for Collecting and banking relapsed acute lymphoblastic leukemia research specimens

  • Population: Adult/Pediatric, 30 years or younger
  • Status: Open
  • Contact: 210-325-3803
  • Principal Investigator: Jaime Estrada, MD
  • For the most up to date information, visit clinicaltrials.gov

AALL08B1: Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

  • Population: Adult/Pediatric, 30 years or younger
  • Status: Open
  • Contact: 210-325-3803
  • Principal Investigator: Jaime Estrada, MD
  • For the most up to date information, visit clinicaltrials.gov

AALL1131: A Phase III Randomized Trial for Newly Diagnosed High Risk B-precursor Acute 
Lymphoblastic Leukemia (ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum (Clofarabine Arm closed)

  • Population: Adult/Pediatric, 1-30 years old
  • Status: Open
  • Contact: 210-325-3803
  • Principal Investigator: Jaime Estrada, MD
  • For the most up to date information, visit clinicaltrials.gov

AALL1231: A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL) and T- Lymphoblastic Lymphoma (T-LLy)

  • Population: Adult/Pediatric, 1-30 years old
  • Status: Open
  • Contact: 210-325-3803
  • Principal Investigator: Jaime Estrada, MD
  • For the most up to date information, visit clinicaltrials.gov

AALL1331: Risk-Stratified Randomized Phase III Testing of Blinatumomab (IND# 117467, NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)

  • Population: Adult/Pediatric, 1-30 years old
  • Status: Open
  • Contact: 210-325-3803
  • Principal Investigator: Jaime Estrada, MD
  • For the most up to date information, visit clinicaltrials.gov

Defibrotide treatment IND Protocol investigating the use of Defibrotide in the treatment of hepatic veno-occlusive disorder

  • Population: Adult/Pediatric, all ages
  • Status: Open
  • Contact: 210-325-3803
  • Principal Investigator: Seema Naik, MD
  • For the most up to date information, visit clinicaltrials.gov

Biological assessment of blood, marrow and solid tumors in patients with malignant disorders

  • Population: Adult, 18 years and older
  • Status: Open
  • Contact: 210-643-7218
  • Principal Investigator: Paul Shaughnessy, MD

ANHL1131: Intergroup Trial for Children or Adolescents with B-cell Non-Hodgkin Lymphoma NHL or Mature B-cell Leukemia B- AL: Evaluation of Rituximab (IND #10385) Efficacy and Safety in High Risk Patients

  • Population: Pediatric, 6 months to 17 years old
  • Status: Open
  • Contact: 210-325-3803
  • Principal Investigator: Jaime Estrada, MD
  • For the most up to date information, visit clinicaltrials.gov

ALTE11C1: Longitudinal Assessment of Ovarian Reserve in Adolescents with Lymphoma

  • Population: Adult/Pediatric, females younger than 30 years old
  • Status: Open
  • Contact: 210-325-3803
  • Principal Investigator: Jaime Estrada, MD
  • For the most up to date information, visit clinicaltrials.gov

SCRI LYM 82: A randomized, open-label, multicenter, phase II trial evaluating the safety and activity of pinatuzumab vedotin (DCDT2980S) in combination with rituximab or polatuzumab vedotin (DCDS4501A) in combination with rituximab and a non-randomized phase Ib/II evaluation of polatuzumab vedotin in combination with obinutuzumab in patients with relapsed or refractory B-Cell non-Hodgkin's lymphoma

  • Population: Adult, 18 years and older
  • Status: Pending
  • Contact: 210-643-7218
  • Principal Investigator: Seema Naik, MD
  • For the most up to date information, visit clinicaltrials.gov

SCRI HEMREF 35: A Phase I open-label, Multi-dose, dose escalation study of PRT062070 in Patients with relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or B-Cell non Hodgkin lymphoma (NHL)

  • Population: Adult, 18 years and older
  • Status: Pending
  • Contact: 210-643-7218
  • Principal Investigator: Seema Naik, MD
  • For the most up to date information, visit clinicaltrials.gov

SCRI LYM 105: A Phase 2, Open-Label Study of the Safety and Efficacy of INCB040093 and INCB040093 Combined With INCB039110 in Subjects With Relapsed or Refractory Hodgkin Lymphoma

  • Population: Adult
  • Status: Pending
  • Contact: 210-643-7218
  • Principal Investigator: Seema Naik, MD
  • For the most up to date information, visit clinicaltrials.gov

LYM110: Medivation: An international Phase 2 open label, efficacy and safety study of MDV9300 in patients with an incomplete response following salvage therapy or autologous stem cell transplantation for relapsed or refractory CD20+ Diffuse large B-Cell Lymphoma

  • Population: Adult
  • Status: Pending
  • Contact: 210-643-7218
  • Principal Investigator: Seema Naik, MD

KITE Pharma: A Phase 2 multicenter study evaluating the efficacy of KTE_C19 in subjects with relapsed/refractory Mantle Cell Lymphoma

  • Population: Adult
  • Status: Pending
  • Contact: 210-643-7218
  • Principal Investigator: Seema Naik, MD

SCRI LYM 100 KITE: A Phase 1-2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Subjects with Refractory Aggressive Non-Hodgkin Lymphoma (NHL)

  • Population: Adult, 18 years and older
  • Status: Pending
  • Contact: 210-643-7218
  • Principal Investigator: Paul Shaughnessy, MD
  • For the most up to date information, visit clinicaltrials.gov

SCRI MM 51: A multicenter Phase 1/2b study of the Burton's tyrosine kinase inhibitor, Ibrutinib (PCI-32765), in combination with Carfilzomib (Kyprolis ™) in subjects with relapsed or relapsed and refractory multiple myeloma

  • Population: Adult, 18 years and older
  • Status: Pending
  • Contact: 210-643-7218
  • Principal Investigator: Paul Shaughnessy, MD
  • For the most up to date information, visit clinicaltrials.gov

SCRI MM 50: Phase II trial of LDE225 (sonidegib) plus Bortezomib in patients with relapsed or relapsed/refractory multiple myeloma with a dose-finding lead-in

  • Population: Adult, 18 years and older
  • Status: Open
  • Contact: 210-643-7218
  • Principal Investigator: Paul Shaughnessy, MD
  • For the most up to date information, visit clinicaltrials.gov

Transplant Trials

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

  • Population: Adult, 18 years and older
  • Status: Open
  • Contact: 210-643-7218
  • Principal Investigator: Paul Shaughnessy, MD
  • For the most up to date information, visit clinicaltrials.gov

SCRI AML 17: (Novartis) Phase 2, randomized comparative trial of midostaurin maintenance to prevent relapse after hematopoietic stem cell transplantation in patients with FLT3-ITD mutated AML (Novartis)

  • Population: Adult, 18 years and older
  • Status: Open
  • Contact: 210-241-0266
  • Principal Investigator: Jose Cruz, MD
  • For the most up to date information, visit clinicaltrials.gov

ASCT1221: A Randomized Phase II Study Comparing Two Different Conditioning Regimens Prior to Allogeneic Hematopoietic Cell Transplantation (HCT) for Children with Juvenile Myelomonocytic Leukemia (JMML)

  • Population: Pediatric, 3 months to 17 years old
  • Status: Open
  • Contact: 210-325-3803
  • Principal Investigator: Jaime Estrada, MD
  • For the most up to date information, visit clinicaltrials.gov

Mesoblast: A 1-Year, Multicenter, Randomized, Open-Label Controlled Study to Evaluate the Efficacy and Safety of Umbilical Cord Blood Cells Expanded Ex Vivo With Mesenchymal Precursor Cells for Hematopoietic Recovery in Patients With Hematologic Malignancy

  • Population: Adult/Pediatric, less than 65 years old
  • Status: Open
  • Contact: 210-325-3803
  • Principal Investigator: Paul Shaughnessy, MD
  • For the most up to date information, visit clinicaltrials.gov

CTN 0903: Allogeneic Hematopoietic Cell transplant for hematological cancers and MDS in HIV-Infected individuals

  • Population: Adult/Pediatric, all ages
  • Status: Open
  • Contact: 210-643-7218
  • Principal Investigator: Paul Shaughnessy, MD
  • For the most up to date information, visit clinicaltrials.gov

CTN 1101: Haplo versus Cord Transplant

  • Population: Adult, 18 years and older
  • Status: Open
  • Contact: 210-643-7218
  • Principal Investigator: Paul Shaughnessy, MD
  • For the most up to date information, visit clinicaltrials.gov

SCRI Nordic: A phase 1 study of 177 LU-DOTA-HH1 (Betalutin) as part of a high-dose BEAM conditioning regimen in patients with CD37 positive Difuse Large B-Cell Lymphoma who are candidates for autologous stem cell transplantation

  • Population: Adult, 18 years and older
  • Status: Pending
  • Contact: 210-643-7218
  • Principal Investigator: Seema Naik, MD

MM 42: (Millennium) Open label study to determine the feasibility of MLN9708 as maintenance after allogeneic stem cell transplant for Multiple Myeloma followed by an expansion phase at the maximum tolerated dose

  • Population: Adult, 18 to 70 years and older
  • Status: Open
  • Contact: 210-643-7218
  • Principal Investigator: Paul Shaughnessy, MD
  • For the most up to date information, visit clinicaltrials.gov

10-CBA: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units for transplantation in pediatric and adult patients with hematologic malignancies and other indications

  • Population: Adult/Pediatric, all ages
  • Status: Open
  • Contact: 210-325-3803
  • Principal Investigator: Robert Sanders, MD
  • For the most up to date information, visit clinicaltrials.gov

SCRI HEM SUP 03: (Giliad) A phase 2b, randomized, double-blind, study evaluating antiviral effects, PK, safety and tolerability of GS-5806 in HCT recipients with RSV of the upper respiratory tract

  • Population: Adult, 18 to 75 years old
  • Status: Open
  • Contact: 210-643-7218
  • Principal Investigator: Seema Naik, MD
  • For the most up to date information, visit clinicaltrials.gov

ACCL0933: A Randomized Open-Label Trial of Caspofungin versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML)

  • Population: Adult/Pediatric, 3 months to 29 years old
  • Status: Open
  • Contact: 210-325-3803
  • Principal Investigator: Jaime Estrada, MD
  • For the most up to date information, visit clinicaltrials.gov

COG ACCL0934: A randomized trial of levofloxacin to prevent bacteremia in children being treated for acute leukemia or undergoing hematopoietic stem cell transplantation

  • Population: Adult/Pediatric, 6 months to 20 years old
  • Status: Open
  • Contact: 210-325-3803
  • Principal Investigator: Jaime Estrada, MD
  • For the most up to date information, visit clinicaltrials.gov

ACCL1034: Impact of Cleansing with Chlorhexidine Gluconate (CHG) on Reducing Central Line Associated Bloodstream Infection (CLABSI) and Acquisition of Multi-drug Resistant Organisms (MDRO) in Children with Cancer or Those Receiving Allogeneic Hematopoietic Cell Transplantation (HCT)

  • Population: Adult/Pediatric, 2 months to 20 years old
  • Status: Pending
  • Contact: 210-325-3803
  • Principal Investigator: Jaime Estrada, MD
  • For the most up to date information, visit clinicaltrials.gov

COG ACCL1131: 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)

  • Population: Adult/Pediatric, 6 months to 20 years old
  • Status: Open
  • Contact: 210-325-3803
  • Principal Investigator: Jaime Estrada, MD
  • For the most up to date information, visit clinicaltrials.gov

CTN 1203: Phase 2 trial of randomizing novel approaches for GVHD prevention compared to contemporary controls

  • Population: Adult, 18-75 years old
  • Status: Open
  • Contact: 210-643-7218
  • Principal Investigator: Behyar Zoghi, MD, PhD
  • For the most up to date information, visit clinicaltrials.gov

CTN 1203: Enlivex/Emmes: A randomized, multicenter, double blind vehicle controlled, comparative Phase III study evaluating efficacy, safety and toleratiblity of single dose Apocell for the prevention of graft vs. host disease post transplantation in hmatopoietic malignancies in human leukocyte antigen-matched, related patients

  • Population: Adult, 18 years and older
  • Status: Pending
  • Contact: 210-643-7218
  • Principal Investigator: Behyar Zoghi, MD, PhD

Indiana University: A phase I study evaluating the addition of Bortezomib to an established acute graft versus host disease (aGVHD) prophylaxis regimen in pediatric allogeneic hematopoietic stem cell transplant (alloHSCT) patients

  • Population: Adult/Pediatric, 1-22 years old
  • Status: Pending
  • Contact: 210-325-3803
  • Principal Investigator: Troy Quigg, DO, MS
  • For the most up to date information, visit clinicaltrials.gov

BMT 10: Incyte: A randomized, parallel-cohort Phase 1 study of INCB039110 in combination with corticosteroids for the treatment of grade II-IV aghv

  • Population: Adult, 18 years and older
  • Status: Pending
  • Contact: 210-643-7218
  • Principal Investigator: Behyar Zoghi, MD, PhD

Mesoblast MESO 001: Remestemcel-L (Prochymal®), Ex-vivo Cultured Adult Human Mesenchymal Stem Cells for the Treatment of Acute GVHD

  • Population: Adult/Pediatric, 6 months to 75 years old
  • Status: Pending
  • Contact: 210-325-3803
  • Principal Investigator: Robert Sanders, MD
  • For the most up to date information, visit clinicaltrials.gov

SCRI BMT 08: Actelion, A Phase 2, open-label, single-arm, intra-patient dose-escalation study with ponesimod in patients with symptomatic moderate or severe chronic GVHD inadequately responding to first or second line therapy

  • Population: Adult, 18 to 65 years old
  • Status: Pending
  • Contact: 210-325-3803
  • Principal Investigator: Paul Shaughnessy, MD
  • For the most up to date information, visit clinicaltrials.gov

Mesoblast Expanded Access protocol for steroid refractory acute GVHD pediatric

  • Population: Pediatric, 2 months to 17 years old
  • Status: Open
  • Contact: 210-325-3803
  • Principal Investigator: Robert Sanders, MD
  • For the most up to date information, visit clinicaltrials.gov

NationWide Children's: Infliximab and Basiliximab for treatment of steroid refractory acute GVHD

  • Population: Adult/Pediatric, 18 years old and older
  • Status: Open
  • Contact: 210-325-3803
  • Principal Investigator: Troy Quigg, DO, MS

CTN 1202: Prospective Multi-center cohort for the evaluation of biomarkers predicting risk of complications and mortality following allogeneic HCT

  • Population: Pediatric, 17 years old and younger
  • Status: Open
  • Contact: 210-325-3803
  • Principal Investigator: Robert Sanders, MD
  • For the most up to date information, visit clinicaltrials.gov

PIDTC 6901: A prospective natural history study of diagnosis, treatment and outcomes of children with SCID disorders

  • Population: Pediatric, all ages
  • Status: Open
  • Contact: 210-325-3803
  • Principal Investigator: Troy Quigg, DO, MS

PIDTC 6903: Analysis of patients treated for chronic granulomatous disease since January 1, 1995

  • Population: Pediatric, all ages
  • Status: Pending
  • Contact: 210-325-3803
  • Principal Investigator: Troy Quigg, DO, MS
  • For the most up to date information, visit clinicaltrials.gov

CIBMTR 13-TLEC: Natural History and Biology of Long-term late effects following Hematopoietic cell transplant for childhood hematologic malignancies

  • Population: Pediatric, 17 years and younger
  • Status: Pending
  • Contact: 210-325-3803
  • Principal Investigator: Troy Quigg, DO, MS
  • For the most up to date information, visit clinicaltrials.gov

CTN: Haploidentical Transplantation in Aplastic Anemia

  • Population: Adult/Pediatric
  • Status: Pending
  • Contact: 210-325-3803
  • Principal Investigator: Robert Sanders, MD

SCI Outcomes 16: Evaluation of Patient Outcomes and Healthcare Economics in HSCT based on Donor typing by Insight KIR Profile™

  • Population: Adult, 18 years and older
  • Status: Pending
  • Principal Investigator: Behyar Zoghi, MD, PhD


How do clinical trials work?

Studies are broken down into different groups that each focus on certain things.

  • Phase 1 study investigates safety and side effects and the best dose of study drugs
  • Phase 2 determines the effectiveness and safety
  • Phase 3 looks at effectiveness, side effects and safety compared with other treatments
  • Phase 4 gathers more information after the Food and Drug Administration (FDA) approves the drug and it is on the market

Each cancer trial has a written detailed study design called a “protocol.” A protocol includes why the trial is needed, purpose of the trial, what drug or drugs are being tested and who can join the study. It also includes:

  • Safety measures
  • How outcomes will be measured
  • What information will be gathered about you

Standard Treatment

Standard treatment is treatment that experts agree is appropriate, accepted and widely used. As with any treatment, it will have side effects. For some blood cancers, the standard treatment may only be somewhat effective, in these instances, you may want to consider a clinical trial.

Randomization

This enables doctors to compare new treatments with standard treatments. Patients are divided into different groups at random. The “Control group” receives the best standard treatment available and the “Treatment group” receives the treatment under study. Sometimes a “placebo” maybe used, but rarely in cancer studies.

Placebo

A placebo is designed to look like the medicine being tested, but is not active. A study may compare standard treatment plus a new treatment, to standard treatment plus a placebo. You will be told if the study uses a placebo but you will not know if you are getting the placebo, nor will your study team, this is called “blinding” which allows the research team to look at your side effects without bias.