Clinical trial · Interventional
Phase I/II Study of Pentostatin Combined With Tacrolimus and Mini-Methotrexate for GVHD Prevention After MUD BMT
Phase I/II Study of Pentostatin Combined With Tacrolimus and Mini-Methotrexate for GVHD Prevention After Matched-Unrelated Donor Blood and Marrow Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methotrexate | Drug | Methotrexate | ALIAS |
| Pentostatin | Drug | Pentostatin | ALIAS |
| Tacrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- No Pentostatin
- description
- Group 1: No Pentostatin
- interventionNames
- Drug: Pentostatin
- Drug: Tacrolimus
- Drug: Methotrexate
- type
- EXPERIMENTAL
- label
- Pentostatin 0.5
- description
- Group 2: Pentostatin 0.5 mg/m\^2
- interventionNames
- Drug: Pentostatin
- Drug: Tacrolimus
- Drug: Methotrexate
- type
- EXPERIMENTAL
- label
- Pentostatin 1
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDParmar S, Del Lima M, Zou Y, Patah PA, Liu P, Cano P, Rondon G, Pesoa S, de Padua Silva L, Qazilbash MH, Hosing C, Popat U, Kebriaei P, Shpall EJ, Giralt S, Champlin RE, Stastny P, Fernandez-Vina M. Donor-recipient mismatches in MHC class I chain-related gene A in unrelated donor transplantation lead to increased incidence of acute graft-versus-host disease. Blood. 2009 Oct 1;114(14):2884-7. doi: 10.1182/blood-2009-05-223172. Epub 2009 Aug 4. PMID 19654407