Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia
This study has been completed.
Sponsor:
Roswell Park Cancer Institute
Collaborator:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00053157
First received: January 27, 2003
Last updated: January 30, 2013
Last verified: January 2013
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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.
| Condition | Intervention |
|---|---|
|
Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms |
Biological: sargramostim |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
acute promyelocytic leukemia
familial acute myeloid leukemia with mutated CEBPA
primary myelofibrosis
MedlinePlus related topics:
Acute Myeloid Leukemia
Anemia
Aplastic Anemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Leukemia
Lymphoma
Myelodysplastic Syndromes
Drug Information available for:
Sargramostim
U.S. FDA Resources
Further study details as provided by Roswell Park Cancer Institute:
| Enrollment: | 10 |
| Study Start Date: | June 2002 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 5 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053157
Locations
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
| Study Chair: | Philip L. McCarthy, MD | Roswell Park Cancer Institute |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00053157 History of Changes |
| Other Study ID Numbers: | RPC 02-01, RPCI-RPC-0201 |
| Study First Received: | January 27, 2003 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Roswell Park Cancer Institute:
|
graft versus host disease accelerated phase chronic myelogenous leukemia chronic phase chronic myelogenous leukemia primary myelofibrosis childhood acute myeloid leukemia/other myeloid malignancies childhood acute promyelocytic leukemia (M3) recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia recurrent childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma recurrent childhood small noncleaved cell lymphoma recurrent/refractory childhood Hodgkin lymphoma de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes |
meningeal chronic myelogenous leukemia noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult lymphoblastic lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma noncontiguous stage II mantle cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Burkitt lymphoma |
Additional relevant MeSH terms:
|
Neoplasms Graft vs Host Disease Leukemia Lymphoma Lymphoma, Non-Hodgkin Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Lymphoma, Large-Cell, Immunoblastic |
Myelodysplastic-Myeloproliferative Diseases Immune System Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
ClinicalTrials.gov processed this record on June 17, 2013