Bone Marrow Transplant (BMT)

Graft Versus Host Disease

1

Disease Status and/or Stage	Chronic GvHD
Protocol Title	CALGB 100101: A Phase II Trial of Pentostatin for the Treatment of Patients with Refractory Chronic Graft-Versus-Host Disease
PI	Tsiporah Shore, MD
Contact	June Greenberg, RN 212-746-2651
Key Eligibility	Histological documentation of chronic GvHD following allogeneic hematopoietic stem cell transplantation (HCT) Failed treatment with or experienced progression after prior corticosteroids for extensive chrnoic GvHD
Treatment Overview	Pentostatin IV over 20-30 minutes every 2 weeks Patients should receive an effective antiemetic 30 minutes prior to each dose of pentostatin Patients should receive prophylactic therapy

2

Disease Status and/or Stage	Bone Marrow Tranplant/GVHD
Protocol Title	A Phase III, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prochymal™ (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion in Combination with Corticosteroids for the Treatment of Newly Diagnosed Acute GVHD
PI	Michael Schuster, MD
Contact	June Greenberg, RN 212-746-2651
Key Eligibility	Patients are eligible if: - They have received an allogeneic hematopoietic stem cell transplant using either bone marrow, peripheral blood stem cells or cord blood or administered a donor leukocyte infusion; - They have newly diagnosed Grades B-D Acute GVHD
Treatment Overview	Subjects will be treated with investigational agent [Prochymal™ or Placebo] for a total of 6 infusions administered over a 4 weeks period. Four infusions will be administered over the first 2 weeks, twice weekly. The remaining 2 infusions will be administered once weekly for the next 2 weeks.

3

Disease Status and/or Stage	Bone Marrow Tranplant/GVHD
Protocol Title	A Phase III, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prochymal™ (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD
PI	Michael Schuster, MD
Contact	June Greenberg, RN 212-746-2651
Key Eligibility	Patients must have Grades B-D acute GVHD, that has failed to respond to steroid treatment and secondary to allogeneic hematopoietic stem cell transplantation (HSCT). Patients must be able to be treated within 4 days of randomization.
Treatment Overview	Patients will be treated with investigational agent [Prochymal™ or Placebo] twice per week for each of 4 consecutive weeks. A therapy assessment will be performed on day 32 (±2 days) to determine whether continued treatment is indicated. Eligible subjects will receive an additional 4 weeks of investigational agent (either Prochymal™ or Placebo) once per week according to the original randomization. Subjects may receive treatment up to day 100.

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