Non Hodgkin Lymphoma Clinical Trial
Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia
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.
Full 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.
Eligibility 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
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There is 1 Location for this study
Buffalo New York, 14263, United States
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