The Effect of Folinic Acid Rescue Following MTX GVHD Prophylaxis on Regimen Related Toxicity and Transplantation Outcome

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the impact of folinic acid (FA) -rescue following methotrexate (MTX) graft-versus-host disease (GVHD) prophylaxis on regimen related toxicity and transplantation outcomes after allogeneic hematopoietic cell transplantation (alloHCT) in a double blind randomized controlled trial.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rabin Medical Center
• Treatments: Folic Acid; Leucovorin; Levoleucovorin; Methotrexate

Criteria

Inclusion Criteria:

• Acute leukemia in complete remission (CR) or myelodysplastic syndrome;

• First transplantation;

• Peripheral blood graft;

• Matched sibling or unrelated donor or one antigen or allelic mismatched sibling or unrelated donor (10/10 or 9/10 human leukocyte antigen match );

• Myeloablative or reduced intensity preparative regimen;

• Post-transplant GVHD prophylaxis consisting of a calcineurin inhibitor (CSA or tacrolimus) and methotrexate;

• Glutamate Pyruvate Transaminase (GPT) < 3 times upper normal limit (UNL) and creatinine ≤ 1.4 mg%;

• Written informed consent;

Exclusion Criteria:

• True non-myeloablative preparative regimen (TBI 200 +/- fludarabine);

• Acute leukemia not in remission;

• GPT > 3 times upper normal limit or creatinine > 1.4 mg%;

• Bone marrow, haploidentical or cord blood grafts;