Cyclophosphamide Versus Anti-thymocyte Globulin for GVHD Prophylaxis After RIC Allo-SCT

• Status: Completed
• Trial end date: 2020-10-12
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed as a two arm randomized Phase II, multicenter trial comparing cyclophosphamide to anti-thymocyte globulin for Graft-versus-Host Disease (GVHD) prophylaxis in patients with hematologic malignancies undergoing reduced intensity conditioning hematopoietic stem cell transplantation.

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

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Antilymphocyte Serum; Cyclophosphamide; Cyclosporine; Cyclosporins; Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria :

• Patients aged between 18 and 65 years

• Presence of a hematologic malignancy for which a reduced-intensity conditioning allo-SCT is indicated (eligibility criteria for RIC allo-SCT include at least one of the following parameters: (i) patient age older than 50 years; (ii) heavily pre-treated patients who received an autologous hematopoietic SCT (auto-SCT) or with more than 2 lines of chemotherapy before allo-SCT; and (iii) patients with poor performance status because of significant medical comorbidities as described by Sorror et al.

• Karnofsky index ≥ 70%

• Availability of a sibling or unrelated stem-cell donor (10/10-HLA matched unrelated donor)

• Efficient contraceptive method within 1 month for women and 3 months for men after the last dose of treatment

• Written informed consent.

Exclusion Criteria:

• Creatinine clearance less than 30 mL/min

• Bilirubin or amino-transferases above 3X upper normal limit

• Cardiac ejection fraction less than 40%

• Pulmonary impairment with <50% lung carbon monoxide diffusing capacity (DLCO)

• Known hypersensitivity or contraindication to the use of post-transplant Cy and ATG

• Any circumstance that precludes the use of the drugs involved in the protocol

• Pregnancy