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

Sponsors and Collaborators:	Roswell Park Cancer Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00053157

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 Diseases	Biological: sargramostim

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Anemia Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

June 2002

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.

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Philip L. McCarthy, MD

Roswell Park Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000269288, RPCI-RPC-0201
Study First Received:	January 27, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00053157 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

graft versus host disease
accelerated phase chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
chronic idiopathic 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

Study placed in the following topic categories:

Aplastic Anemia
Lymphoma, Mantle-Cell
Mantle Cell Lymphoma
Follicular Lymphoma
Graft Versus Host Disease
Preleukemia
Acute Myelocytic Leukemia
Acute Myeloid Leukemia, Adult
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Promyelocytic, Acute
Neoplasm Metastasis
Hodgkin Disease
Myelodysplastic Myeloproliferative Disease
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma

Immunoproliferative Disorders
Hematologic Diseases
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Myeloproliferative Disorders
Leukemia, Myeloid
B-cell Lymphomas
Leukemia, Myeloid, Accelerated Phase
Chronic Myelogenous Leukemia
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous
Acute Lymphoblastic Leukemia, Childhood
Leukemia, Lymphoid
Hematologic Neoplasms
Precancerous Conditions
Hodgkin Lymphoma, Childhood

Additional relevant MeSH terms:

Disease
Immunoproliferative Disorders
Neoplasms by Histologic Type
Precancerous Conditions
Immune System Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Lymphatic Diseases
Leukemia
Preleukemia

Neoplasms
Pathologic Processes
Syndrome
Lymphoma, Large-Cell, Immunoblastic
Graft vs Host Disease
Bone Marrow Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Myelodysplastic-Myeloproliferative Diseases
Lymphoma

ClinicalTrials.gov processed this record on September 11, 2009