Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

sargramostim

Biological
Who is being recruted

Anemia+16

+ Anemia, Refractory

+ Bone Marrow Diseases

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 1999
See protocol details

Summary

Principal SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last updated: April 17, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00003961
Principal SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last updated: April 17, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AnemiaAnemia, RefractoryBone Marrow DiseasesChronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesAnemia, Refractory, with Excess of BlastsLeukemiaMyelodysplastic SyndromesMyeloproliferative DisordersLeukemia, Myelomonocytic, ChronicMyelodysplastic-Myeloproliferative DiseasesLeukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, United StatesOpen Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Google Maps
CompletedOne Study Center