Phase I/II Study of Pentostatin Combined With Tacrolimus and Mini-Methotrexate for GVHD Prevention After MUD BMT
Completed · Phase 1/Phase 2
Conditions studied: Leukemia, Lymphoma
In brief
Primary Objective: 1\. To determine efficacy of escalating doses of pentostatin in combination with tacrolimus and methotrexate for the prevention of acute graft-versus-host disease (GVHD) in the context of unrelated donor and one antigen mismatched related donor transplantation. Secondary Objectives: 1. To determine safety of escalating doses of pentostatin in combination with tacrolimus and methotrexate. 2. To reduce the incidence of acute GVHD following transplants with unrelated donor to 40%. 3. To document blood levels of tacrolimus when combined with pentostatin.
Key facts
- Study ID
- NCT00506922
- Run by
- M.D. Anderson Cancer Center
- People needed
- 150
- Starts
- 2000-09-01
- Expected to finish
- 2009-11-01
- Last updated by the study team
- 2015-04-28
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients receiving allogeneic hematopoietic transplants from an unrelated donor or one antigen mismatched related donors.
- Patients with AML, ALL, Hodgkin's disease, MDS (including CMML), CML in late chronic or accelerated phase or in blast crisis, and lymphoma in first or later relapses.
- Patients must have bilirubin < 1.5 mg/dL, DLCO > 50% predicted, LVEF > 45% and performance status 0 or 1.
- Candidates must have a creatinine level < 1.5 mg/dL or a calculated creatinine clearance > 60 ml/min.
You may not qualify if…
- HIV seropositivity
- Uncontrolled infection
- Pregnancy
- Candidates should not have received chemotherapy other than hydroxyurea or Gleevec for at least 3 weeks prior to treatment. Maintenance therapy with oral chemotherapy is acceptable. Treatment day is defined as transplant day +8, which is the date of first dose of pentostatin.
- Diagnosis of myelofibrosis.
Where it is running
- U.T.M.D. Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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