Lymphoma Clinical Trial
Official title:
Phase I/II Study of Pentostatin Combined With Tacrolimus and Mini-Methotrexate for GVHD Prevention After Matched-Unrelated Donor Blood and Marrow Transplantation
Verified date | August 2012 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | November 2009 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Patients receiving allogeneic hematopoietic transplants from an unrelated donor or one antigen mismatched related donors. 2. 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. 3. Patients must have bilirubin < 1.5 mg/dL, DLCO > 50% predicted, LVEF > 45% and performance status 0 or 1. 4. Candidates must have a creatinine level < 1.5 mg/dL or a calculated creatinine clearance > 60 ml/min. Exclusion Criteria: 1. HIV seropositivity 2. Uncontrolled infection 3. Pregnancy 4. 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. 5. Diagnosis of myelofibrosis. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | U.T.M.D. Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | Astex Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients Without GVHD at 100 Days | The primary efficacy endpoint of escalating doses Pentostatin with Tacrolimus + Methotrexate is success, defined to be that the patient is alive, engrafted, and without acute graft-versus-host disease (GVHD) at 100 days. | 100 days | Yes |
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