A Sequentially Adaptive, Open Label, Dose-finding, Phase I/II Trial of Pentostatin in the Treatment of Steroid-refractory Acute Graft Versus Host Disease (aGvHD)
Phase 1/Phase 2
6 Months
N/A
6 Months
N/A
Not Enrolling
Both
Acute Graft Versus Host Disease
Both
Acute Graft Versus Host Disease
Trial Information
A Sequentially Adaptive, Open Label, Dose-finding, Phase I/II Trial of Pentostatin in the Treatment of Steroid-refractory Acute Graft Versus Host Disease (aGvHD)
Inclusion Criteria
Inclusion:
- Patients 6 months of age with grade 2 GVHD that is steroid-refractory
- Must be engrafted with ANC 1000/mL, may still be transfusion dependent for platelets
and PRBC
- Time post stem cell infusion < 100 days
- Written informed consent
- Must have adequate renal function (creatinine clearance 40 mL/min/1.73 m2
Exclusion:
- Post-transplant lymphoproliferative disease
- Uncontrolled infection
- Mental illness or other condition preventing full cooperation with the treatment and
monitoring requirements of the study
- ATG within the previous 14 days
- Other immunosuppressive agents (including monoclonal antibodies) when initiated
within the previous 7 days.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
SGI-NIP-010
NCT ID:
NCT00032773
Start Date:
Completion Date:
Related Keywords:
- Acute Graft Versus Host Disease
- acute graft versus host disease
- aGVHD
- allogeneic hematopoietic stem cell transplantation
- peripheral blood stem cell transplantation
- cord blood transplant
- pentostatin
- Nipent
- deoxycoformycin
- Graft vs Host Disease
Name | Location |
|---|---|
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
