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

Sponsor

Roswell Park Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00053157

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms	Biological: sargramostim	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jun 1, 2002

Actual Primary Completion Date :

Aug 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Diagnosis of a malignant hematologic disease, including:
Acute or chronic leukemia
Myelodysplastic syndromes
Myeloproliferative disorder
Hodgkin's lymphoma
Non-Hodgkin's lymphoma OR
Aplastic anemia
Planned transplantation on an RPCI IRB-approved allogeneic stem cell transplantation protocol
HLA-matched (6/6) related donor available