Clinical trial · Interventional

Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome

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

NCT00003961CI-TRIAL-00014287completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Myelodysplastic/Myeloproliferative Diseases	Myelodysplastic/Myeloproliferative Neoplasm	ALIAS	0.90
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
sargramostim	Biological	—	UNRESOLVED

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 65 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Apr 1, 1999
Primary completion: Dec 1, 2007
Completion: Dec 1, 2007
First posted: Jan 27, 2003
Last update posted: Apr 17, 2014
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, refractory cytopenia with multilineage dysplasia, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable

Data updated 22 days agoSource updated Apr 17, 2014source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.