NCT00053157

Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia

Use Of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) To Mobilize Donor Peripheral Blood Stem Cells Along With GM-CSF Administration Post Allogeneic Transplant - A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 5 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy or radiation therapy. Giving sargramostim to the stem cell donor and the patient may reduce the chance of developing graft-versus-host disease following stem cell transplantation. PURPOSE: Clinical trial to study the effectiveness of sargramostim in decreasing graft-versus-host disease in patients who are undergoing donor stem cell transplantation for hematologic cancer or aplastic anemia.

Detailed description

OBJECTIVES: * Determine the efficacy of sargramostim (GM-CSF) to mobilize CD34+ hematopoietic stem cells in donors and to reduce graft-vs-host disease in patients after allogeneic stem cell transplantation (SCT) for hematologic malignancy or aplastic anemia. * Determine the safety of GM-CSF after allogeneic SCT transplantation in these patients. OUTLINE: This is a pilot study. * Donors: Donors receive sargramostim (GM-CSF) subcutaneously (SC) once daily on days 1-6. Donors undergo stem cell harvest on day 7. Donors may undergo up to 3 apheresis procedures to reach the target stem cell dose and may receive additional GM-CSF prior to each collection. * Patients: Patients receive conditioning therapy as per transplantation protocol RP98-15. Patients undergo allogeneic stem cell transplantation on day 0. Patients then receive GM-CSF SC once daily beginning on day 7 and continuing until blood counts recover. Patients are followed weekly until day 100 and then at days 180 and 360. PROJECTED ACCRUAL: A total of 10 patients and 10 donors will be accrued for this study.

Conditions

• Chronic Myeloproliferative Disorders
• Graft Versus Host Disease
• Leukemia
• Lymphoma
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	sargramostim

Timeline

• Start date: 2002-06-01
• Primary completion: 2004-08-01
• First posted: 2003-01-28
• Last updated: 2022-10-05

Locations

1 site across 1 country: United States