Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

April 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00003961 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome

Official Title ^ICMJE

Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) After T-Lymphocyte Depleted Allogeneic BMT for Myelodysplastic Syndromes

Brief Summary

RATIONALE: Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood.

PURPOSE: Phase II trial to study the effectiveness of sargramostim after bone marrow transplantation in treating patients who have myelodysplastic syndrome.

Detailed Description

OBJECTIVES:

Determine the effect of sargramostim (GM-CSF) on the progression-free 1-year survival of patients with myelodysplastic syndrome who have undergone T-cell-depleted CD34+ augmented allogeneic bone marrow transplantation.

OUTLINE: All patients receive elutriated, CD34+ stem cell augmented donor bone marrow according to another protocol on day 0.

Patients receive sargramostim (GM-CSF) subcutaneously on days 5-60.

Patients are followed on days 120, 180, 360 and periodically thereafter.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 3-4 years.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases

Intervention ^ICMJE

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 ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Cytologically proven myelodysplastic syndrome (MDS) of one of the following types:
- Refractory anemia with excess blasts (RAEB)
- RAEB in transformation
- Chronic myelomonocytic leukemia
- MDS with multiple chromosomal abnormalities
- MDS with life threatening cytopenias in at least 2 cell lines
  - Platelet count < 30,000/mm^3 OR
  - Absolute neutrophil count no greater than 1,000/mm^3 OR
  - Anemia requiring transfusion support
- Leukemia out of MDS (meet any of above requirements, but greater than 30% blasts in marrow)
No acute leukemia
Medically eligible for bone marrow transplant according to standard operating procedure of the Sidney Kimmel Cancer Center at Johns Hopkins Blood and Bone Marrow Transplant

PATIENT CHARACTERISTICS:

Age:

18 to 65

Performance status:

ECOG 0-1

Life expectancy:

Not specified

Hematopoietic:

See Disease Characteristics

Hepatic:

Not specified

Renal:

Not specified

Other:

No prior acute allergic reactions to sargramostim (GM-CSF)
Not pregnant
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00003961

Responsible Party

Study ID Numbers ^ICMJE

CDR0000067160, JHOC-J9852, JHOC-98071505, NCI-G99-1544

Study Sponsor ^ICMJE

Sidney Kimmel Comprehensive Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

B. Douglas Smith, MD

Sidney Kimmel Comprehensive Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

January 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP