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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 27, 2003

Last Updated Date

February 6, 2009

Start Date ^†

June 2002

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00053157 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

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

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.

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 Phase

Study Type ^†

Interventional

Study Design ^†

Supportive Care

Condition ^†

Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Lymphoma
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases

Intervention ^†

Biological: sargramostim

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

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

Gender

Both

Ages

5 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00053157

Responsible Party

Secondary IDs ^††

RPCI-RPC-0201

Study Sponsor ^†

Roswell Park Cancer Institute

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Study Chair:

Philip L. McCarthy, MD

Roswell Park Cancer Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2004

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.