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Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome

Primary Purpose

Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sargramostim
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
April 16, 2014
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003961
Brief Title
Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome
Official Title
Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) After T-Lymphocyte Depleted Allogeneic BMT for Myelodysplastic Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
sargramostim

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B. Douglas Smith, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States

12. IPD Sharing Statement

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Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome

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