Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)

Status: Recruiting
Phase: Phase 3
Diagnosis: Graft-versus-Host-Disease
NCT ID: NCT01295710 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-216

 

The study objective is to compare the efficacy and safety of US-ATG-F as a supplement to standard of care prophylaxis versus standard of care prophylaxis alone in moderate to severe chronic GVHD-free survival.

 

Conducting Institutions:
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Massachusetts General Hospital

Overall PI:
Robert Soiffer, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
James Levine, MD, Beth Israel Deaconess Medical Center
Yi-Bin Chen, MD, Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Kimberly Phillips, kimberly_phillips@dfci.harvard.edu
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Key Inclusion Criteria: - Patients designated to undergo allogeneic peripheral blood or bone marrow stem cell transplantation following the diagnosis of one of the primary diseases in early or intermediate disease status (i.e., acute myeloid leukemia, acute lymphoid leukemia, and myelodysplastic syndrome) - Patients with an unrelated HLA-A,-B, -C and -DRBI matched donor - Patients with a Karnofsky Performance Score ≥ 70% Key Exclusion Criteria: - Clinically significant concomitant diseases (i.e., cardiac, pulmonary, renal and CNS) - Bacterial, viral, or fungal infections - Known positive for Hepatitis B surfaces antigen, or Hepatitis C antibody, or who have been tested positive for HIV - Patients with any concurrent malignancy. Patients with prior malignancy being curatively treated and disease-free for less than 10 years - Known contraindications to the administration of rabbit immunoglobulin antibodies - Hypersensitivity to methylprednisolone, tacrolimus, methotrexate or any excipients contains in these products
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