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 | Acute GvHD |
|---|---|
| Protocol Title | A Randomized, Double Blind, Placebo-Controlled Trial to Evaluate Palifermin (rHuKGF) in the Reduction of Acute Graft Versus Host Disease in Subjects with Hematologic Malignancies Undergoing Allogeneic Marrow/PBPC Transplantation |
| PI | Tsiporah Shore, MD |
| Contact | June Greenberg, RN 212-746-2651 |
| Key Eligibility |
- Subjects with hematologic malignancies who are considered eligible for Cy/TBI +/- VP-16; TBI/VP-16; Mel/TBI; Bu/Cy; Bu/Mel, or Flu/Mel conditioning therapy with allogeneic stem cell support (contact research nurse for more information or conditioning therapy clarification) - Subjects with a 6/6 HLA-matched family member or unrelated donor who would provide donor marrow/peripheral progenitor stem cells. |
| Treatment Overview |
Arm A (control): Placebo 60 mcg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 mcg/kg administered once at least 96 hours from last 60 mcg/kg dose of placebo. Arm B (treatment): Palifermin 60 mcg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 mcg/kg administered once at least 96 hours from last 60 mcg/kg dose of palifermin. |
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 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. |
| Last updated: July 25, 2007 |  |
