Phase 2
N=38
Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease
Graft Versus Host Disease
Bottom Line
View on ClinicalTrials.gov: NCT00074035 ↗Enrolled (actual)
38
Serious AEs
41.2%
Results posted
Mar 2017
Primary outcome: Primary: Response Rate — 20 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pentostatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate |
20 | — |
| SECONDARY Grade 3 or Higher Non-hematologic Adverse Events |
3; 4; 2; 10; 1; 1 | — |
| SECONDARY Overall Survival At 1 Year |
53 | — |
| SECONDARY Overall Survival At 2 Years |
50 | — |
Summary
RATIONALE: Pentostatin may be effective in treating chronic graft-versus-host disease by stopping the immune system from rejecting donor stem cells or donor white blood cells.
PURPOSE: This phase II trial is studying how well pentostatin works in treating patients with chronic graft-versus-host disease that is refractory (not responsive) to treatment with steroids.
Eligibility Criteria
- Histologic documentation of chronic GvHD following allogeneic HCT or donor lymphocyte infusion.
- Patients may have progressive, quiescent, or de novo onset chronic GvHD.
- Patients with extensive stage chronic GvHD requiring systemic immunosuppressive therapy are eligible. Patients with limited stage disease are excluded. Extensive stage is defined according to Seattle criteria (9) as either:
- Generalized skin involvement or
- Limited skin involvement or hepatic involvement with any one of the following:
- Liver histology showing chronic progressive hepatitis, bridging necrosis or cirrhosis
- Eye involvement (Schirmer's test with 10 mg/kg methylprednisolone or equivalent to maintain a partial response or better at 18 weeks of corticosteroid treatment.
4.2 Patients with progression of extensive stage chronic GvHD after a prior history of treatment with at least 18 weeks of corticosteroids, now requiring the reintroduction of corticosteroids (> 10 mg/day methylprednisolone or equivalent) or an additional agent (including photopheresis, PUVA) for treatment.
- Patients with established chronic GvHD not improving or progressing on other immunosuppressive agents are also eligible if steroid refractoriness has been established previously.
- Age ≥ 18 years
- Performance Status 0-3
- Patients on mechanical ventilation are excluded.
- No active infection. Patients with active infection requiring antibiotic therapy are not eligible until infection is controlled.
- No HIV infection. Patients with HIV infection are excluded because of safety concerns in this patient population.
- Non-pregnant and non-nursing. Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial (although it is unlikely that successful pregnancy will occur in patients with chronic GvHD). Appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives (Norplant®), or double barrier method (diaphragm plus condom).
- Required Initial Laboratory Values:
- Calc. Creatinine Clearance ≥ 30 mL/min/1.73 m^2
- ANC > 1000/μL
- Platelets > 50,000/μL without transfusion
Data sourced from ClinicalTrials.gov (NCT00074035). 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.