Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia
NCT ID: NCT00053157
Last Updated: 2022-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2002-06-30
Brief Summary
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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.
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Detailed Description
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* 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
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Study Design
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SUPPORTIVE_CARE
Interventions
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sargramostim
Eligibility Criteria
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Inclusion Criteria
* 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
5 Years
60 Years
ALL
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Principal Investigators
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Philip L. McCarthy, MD
Role: STUDY_CHAIR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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RPCI-RPC-0201
Identifier Type: -
Identifier Source: secondary_id
RPC 02-01
Identifier Type: -
Identifier Source: org_study_id
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