TAC/MTX vs. TAC/MMF/PTCY for Prevention of Graft-versus-Host Disease and Microbiome and Immune Reconstitution Study (BMT CTN 1703/1801)

Completed · Phase 3

Conditions studied: Acute Leukemia, Chronic Myelogenous Leukemia (CML), Myelodysplasia, Lymphoma

In brief

1703: The study is designed as a randomized, phase III, multicenter trial comparing two acute graft-versus-host disease (aGVHD) prophylaxis regimens: tacrolimus/methotrexate (Tac/MTX) versus post-transplant cyclophosphamide/tacrolimus/mycophenolate mofetil (PTCy/Tac/MMF) in the setting of reduced intensity conditioning (RIC) allogeneic peripheral blood stem cell (PBSC) transplantation. 1801: The goal of this protocol is to test the primary hypothesis that the engraftment stool microbiome diversity predicts one-year non-relapse mortality in patients undergoing reduced intensity allogeneic HCT.

Key facts

Study ID: NCT03959241
Run by: Medical College of Wisconsin
People needed: 431
Starts: 2019-06-25
Expected to finish: 2022-09-19
Last updated by the study team: 2024-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 18.0 years or older at the time of enrollment on Segment A
Patients with acute leukemia or chronic myelogenous leukemia with no circulating blasts and with less than 5% blasts in the bone marrow
Patients with myelodysplasia/chronic myelomonocytic leukemia with no circulating blasts and with less than 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with <5% vs. 5-10% blasts in this disease)
Patients with relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma with chemosensitive disease at time of transplantation
Patients with lymphoma [follicular lymphoma, Hodgkin lymphoma, diffuse large B cell lymphoma, mantle cell lymphoma, peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma and anaplastic large cell lymphoma] with chemosensitive disease at the time of transplantation
Planned reduced intensity conditioning regimen (see eligible regimens in Table 2.4a)
Patients must have a related or unrelated peripheral blood stem cell donor as follows:
Sibling donor must be a 6/6 match for Human Leukocyte Antigen-A (HLA)-A and -B at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing, and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation.
Unrelated donor must be a 7/8 or 8/8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing. Unrelated donor must be willing to donate peripheral blood stem cells and meet National Marrow Donor Program (NMDP) criteria for donation.
Cardiac function: Left ventricular ejection fraction at least 45%
Estimated creatinine clearance acceptable per institutional guidelines
Pulmonary function: Diffusing capacity of lung for carbon monoxide (DLCO) corrected for hemoglobin at least 40% and forced expiratory volume at one second (FEV1) predicted at least 50%
Liver function acceptable per institutional guidelines
Karnofsky Performance Score at least 60%
Female patients (unless postmenopausal for at least 1 year before the screening visit, or surgically sterilized), agree to practice two (2) effective methods of contraception at the same time, or agree to completely abstain from heterosexual intercourse, from the time of signing the informed consent through 12 months post-transplant (see Section 2.6.4 for definition of postmenopausal)
Male patients (even if surgically sterilized), of partners of women of childbearing potential must agree to one of the following: practice effective barrier contraception (see Section 2.6.4 for list of barrier methods), or abstain from heterosexual intercourse from the time of signing the informed consent through 12 months post-transplant
Plans for the use of post-transplant maintenance therapy must be disclosed upon enrollment and must be used irrespective of the outcome of the randomization. Please note that THIS DOES NOT INCLUDE INVESTIGATIONAL AGENTS and maintenance therapy with investigational treatment requires approval by the study chairs.
Voluntary written consent obtained prior to the performance of any study-related procedure that is not a part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.

You may not qualify if…

Prior allogeneic transplant
Active central nervous system (CNS) involvement by malignant cells
Patients with secondary acute myeloid leukemia arising from myeloproliferative disease, including chronic myelomonocytic leukemia (CMML)
Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment.
Presence of clinically significant fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated
Patients seropositive for human immunodeficiency virus (HIV) with detectable viral load. HIV+ patients with an undetectable viral load on antiviral therapy are eligible.
Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
Female patients who are pregnant (as per institutional practice) or lactating
Patients with a serious medical or psychiatric illness likely to interfere with participation in this clinical study
Patients with prior malignancies except resected non-melanoma skin cancer or treated cervical carcinoma in situ. Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously must be reviewed and approved by the Protocol Officer or Chairs.
Planned use of antithymocyte globulin (ATG) or alemtuzumab in conditioning regimen

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States
City of Hope National Medical Center — Duarte, California, United States
University of California, San Francisco — San Francisco, California, United States
Stanford Hospital and Clinics — Stanford, California, United States
University of Florida College of Medicine (Shands) — Gainesville, Florida, United States
University of Miami — Miami, Florida, United States
H. Lee Moffitt Cancer Center — Tampa, Florida, United States
Emory University — Atlanta, Georgia, United States
Blood & Marrow Transplant Program at Northside Hospital — Atlanta, Georgia, United States
University of Chicago — Chicago, Illinois, United States
Loyola University — Maywood, Illinois, United States
Indiana University Simon Cancer Center — Indianapolis, Indiana, United States
Indiana BMT - St. Francis Hospital — Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
University of Kansas Hospital — Kansas City, Kansas, United States
Johns Hopkins University — Baltimore, Maryland, United States
Dana Farber Cancer Institute/Brigham & Women's — Boston, Massachusetts, United States
Dana Farber Cancer Institute/Massachusetts General Hospital — Boston, Massachusetts, United States
University of Michigan — Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Children's Hospital of Michigan — Detroit, Michigan, United States
University of Minnesota — Minneapolis, Minnesota, United States
Mayo Clinic - Rochester — Rochester, Minnesota, United States
Washington University/Barnes Jewish Hospital — St Louis, Missouri, United States
Mount Sinai Medical Center — New York, New York, United States
Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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