Phase 2 Completed N=150 Treatment

Phase I/II Study of Pentostatin Combined With Tacrolimus and Mini-Methotrexate for GVHD Prevention After MUD BMT

leukemia · Lymphoma

Source: ClinicalTrials.gov NCT00506922 ↗

Enrolled (actual)

150

Serious AEs

0.0%

Results posted

Mar 2011

Primary outcomePrimary: Number of Patients Without GVHD at 100 Days — 100 participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Without GVHD at 100 Days	100	—

Eligibility Criteria

Inclusion Criteria

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 50% predicted, LVEF > 45% and performance status 0 or 1.
Candidates must have a creatinine level 60 ml/min.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00506922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.