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

Not Applicable

Completed

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

• Registration Number: NCT00053157
• Lead Sponsor: Roswell Park Cancer Institute

Brief 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.

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2003-01-27
• Study First Submitted QC: 2003-01-27
• Study First Posted: 2003-01-28
• Primary Completion: 2004-08
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-03
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States