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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00053157
Date of registration: 27/01/2003
Prospective Registration: No
Primary sponsor: Roswell Park Cancer Institute
Public title: Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia
Scientific 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
Date of first enrolment: June 2002
Target sample size: 10
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00053157
Study type:  Interventional
Study design:  Primary Purpose: Supportive Care  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Philip L. McCarthy, MD
Address: 
Telephone:
Email:
Affiliation:  Roswell Park Cancer Institute
Key inclusion & exclusion 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



Age minimum: 5 Years
Age maximum: 60 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Lymphoma
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Intervention(s)
Biological: sargramostim
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
RPC 02-01
RPCI-RPC-0201
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Cancer Institute (NCI)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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