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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00053157
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : January 31, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Roswell Park Cancer Institute

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : June 2002
Actual Primary Completion Date : August 2004

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   5 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053157


Locations
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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Study Chair: Philip L. McCarthy, MD Roswell Park Cancer Institute
More Information
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ClinicalTrials.gov Identifier: NCT00053157    
Other Study ID Numbers: RPC 02-01
RPCI-RPC-0201
First Posted: January 28, 2003    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013
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:
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Lymphoma
Leukemia
Preleukemia
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Graft vs Host Disease
Syndrome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Sargramostim
Immunologic Factors
Physiological Effects of Drugs