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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
Not Enrolling
Both
Acute Graft Versus Host Disease

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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 CenterHouston, Texas  77030-4096