Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention

• Status: Active, not recruiting
• Trial end date: 2021-08-12
• Target enrollment: 0
• Participant gender: All

Summary

This randomized clinical trial studies standard GVHD prophylaxis with tacrolimus and methotrexate compared to tacrolimus, mycophenolate mofetil and a reduced-dose methotrexate in patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplant. Both mycophenolate mofetil and reduced-dose methotrexate, in combination with a calcineurin inhibitor, have been shown to be safe and effective in GVHD prevention with less toxicity than standard dose methotrexate. It is not yet known, however, whether this combination of mycophenolate mofetil and reduced-dose methotrexate with tacrolimus is more effective than tacrolimus and standard dose methotrexate in preventing GVHD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Methotrexate; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

Inclusion Criteria:

• Patients must have one of the following documented diseases:

• Chronic myelogenous leukemia

• Chronic lymphocytic leukemia

• Multiple myeloma

• Myelodysplasia

• Myeloproliferative disorder

• Non-Hodgkin's lymphoma

• Hodgkin's disease

• Acute myelogenous leukemia

• Acute lymphoblastic leukemia

• Acute biphenotypic leukemia

• Patients must be undergoing a myeloablative allogeneic hematopoietic cell transplant with one of the following conditioning regimens:

• Busulfan (≥ 12.8 mg/kg IV or PO) and cyclophosphamide (≥ 120 mg/kg)

--- Busulfan dose may be adjusted according to pharmacokinetics targeting a daily AUC of 5000 μmol-min/L, per institution standard of practice.

• Total body irradiation (TBI) (≥ 1200 cGy) and etoposide (60 mg/kg)

• TBI (≥ 1200 cGy) and cyclophosphamide (120 mg/kg)

• Patient must have achieved and be in complete morphologic remission prior to starting conditioning regimen

• Patient's donor must be a related or unrelated human leukocyte antigen (HLA) 8/8 allele-level match (HLA-A, B, C and DRB1)

• Adult patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; pediatric patients must have Lansky score ≥ 60%

• Patients must have a life expectancy of 100 days

• Patients must sign written informed consent

Exclusion Criteria:

• Patients who have undergone any prior transplant

• Patients who are seropositive for human immunodeficiency virus (HIV)

• Patients with any medical illness or concurrent psychiatric illness which, in the investigators' opinion, cannot be adequately controlled with appropriate therapy

• Patients who are pregnant or lactating