Print Friendly Page

Protocol No. BMTCTN1703/1801

Principal Investigator Hall, Aric

Phase III

Age Group Adult

Scope National

Sponsor Type Externally Peer-Reviewed

Title BMTCTN1703: A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation BMTCTN1801: Microbiome and Immune Reconstitution in Cellular Therapies and Hematopoietic Stem Cell Transplantation (Mi-Immune)

Objective The purpose of this study is to compare 2 combinations of drugs to prevent graftversus-host disease (GVHD), a serious complication of a stem cell transplant. These combinations are either Tacrolimus/methotrexate or Tacrolimus/mycophenolate mofetil/cyclophosphamide. Doctors want to know which combination is better or if they give the same results. The study will help doctors decide which treatment is best at preventing GVHD for future transplant patients

Treatment
Group A:
  • Tacrolimus: given daily as a pill by mouth or intravenously (IV) through your vein,beginning 3 days before your transplant(We will slowly decrease the amount of drug given to you and eventually stop, this process occurs over several months)
  • Methotrexate: given intravenously (IV) through your vein on 4 different days (1,3, 6 and 11) after your transplant
    Group B:
  • Tacrolimus: daily as a pill by mouth or by intravenously (IV) through your vein, beginning on Day 5 after your transplant(We will slowly decrease the amount of drug given to you and eventually stop, this process occurs over several months)
  • Mycophenolate mofetil: daily intravenously (IV) through your vein or as a pill by mouth 3 times a day, beginning on Day 5 after your transplant, and will continue for 30 days. Your doctor may decide to continue this drug if you still have GVHD
  • Cyclophosphamide: given intravenously (IV) through your vein, over 1-2 hours, on Day 4 and 4 after your transplant

  • Description Phase III Trial of Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

    Key Eligibility
  • Age 18 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 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 less than 5% vs. 5-10% blasts in this disease)
  • Patients with relapsed chronic lymphocytic leukemia with chemosensitive disease at time of transplantation
  • Patients with lymphoma with chemosensitive disease at the time of transplantation
  • Planned reduced intensity conditioning regimen per protocol
  • Patients must have a related or unrelated peripheral blood stem cell donor as follows:
  • Sibling donor must be a 6/6 match for 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 OR
  • 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 NMDP criteria for donation
  • Cardiac function: Left ventricular ejection fraction at least 45%
  • Estimated creatinine clearance acceptable per institutional guidelines
  • Pulmonary function: DLCO corrected for hemoglobin at least 40% and FEV1 predicted at least 50%
  • Liver function acceptable per institutional guidelines
  • Karnofsky Performance Score at least 60%
  • Female and Male of child bearing potential must agree to effective birth control as defined by the protocol
  • 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
    EXCLUSION:
  • Prior allogeneic transplant
  • Active CNS involvement by malignant cells
  • Patients with secondary acute myeloid leukemia arising from myeloproliferative disease,including CMML
  • Patients with uncontrolled bacterial, viral or fungal infections
  • 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 or lactating
  • Planned use of ATG or alemtuzumab in conditioning regimen

  • Applicable Disease Sites Hematologic cancers, other; Leukemia

    Status Open

    Participating Institutions UW Hospital and Clinics