Expired Study
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Buffalo, New York 14263


Purpose:

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.


Study summary:

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.


Criteria:

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 PATIENT CHARACTERISTICS: Age - 5 to 60 Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients and donors must use effective contraception - No known allergy to GM-CSF - No prior of adverse reaction to any yeast recombinant molecule PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior allogeneic stem cell transplantation Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified


NCT ID:

NCT00053157


Primary Contact:

Study Chair
Philip L. McCarthy, MD
Roswell Park Cancer Institute


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14263
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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