Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation in Patients With Hematologic Malignancy

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate whether the combination of cyclophosphamide and abatacept versus the treatment used in standard of care will reduce the incidence of moderate and severe chronic graft-versus-host disease (GVHD) following hematopoietic stem cell transplantation. GVHD occurs when the cells from your donor (the graft) see your body's cells (the host) as different and attack them.

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

Details

• Lead Sponsor: Dimitrios Tzachanis, MD PhD
• Collaborator: Bristol-Myers Squibb
• Treatments: Abatacept; Calcineurin Inhibitors; Cyclophosphamide; Methotrexate; Tacrolimus

Criteria

Inclusion Criteria:

• High risk hematologic malignancy justifying the need for an allogeneic hematopoetic stem cell transplantation: AML, ALL, CML in accelerated or blast phase, MDS/MPN, NHL, Hodgkin lymphoma, and multiple myeloma

• Creatinine clearance > 40

• Adequate hepatic function

• Normal cardiac function (EF > 50%)

Exclusion Criteria:

• Patients with hematologic malignancies for which transplant is not the only curative option, such as AML with good or intermediate cytogenetics or molecular markers in CR1 or CML in chronic phase

• Inability to identify an 10/10 HLA-Matched Donor (related or unrelated) or a haploidentical donor

• Active malignant disease relapse

• Active, uncontrolled infection, uncontrolled cardiac angina, symptomatic congestive heart failure

• Life expectancy <3 months

• Pregnancy or lactation

• Patients may not be receiving any other investigational agents in the last 28 days

• Patients with chronic myeloid leukemia in first chronic phase