Know Cancer

or
forgot password

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


Phase 2
18 Years
65 Years
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

B. Douglas Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067160, J9852

NCT ID:

NCT00003961

Start Date:

April 1999

Completion Date:

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • 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
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410