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Home > "S" Clinical Trials Conditions > Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome  Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome
Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome
For Condition: atypical chronic myeloid leukemia,Myelodysplastic Syndromes,Chronic Myelomonocytic Leukemia,myelodysplastic and myeloproliferative disease
Status: Recruiting
Sponsor(s): Sidney Kimmel Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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 OR - Absolute neutrophil count no greater than 1,000/mm 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
B.Smith, Principal Investigator, Sidney Kimmel Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting B. Smith 410-614-5068
Additional Information:
Study ID Numbers: CDR0000067160; JHOC-98071505,JHOC-J9852,NCI-G99-1544
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003961
Other Chronic Myelomonocytic Leukemia Studies:
1. Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
2. Radiolabeled Monoclonal Antibody Therapy Combined With Total-body Irradiation, Allogeneic Peripheral Stem Cell Transplantation, and Immunosuppression Therapy in Treating Older Patients Who Have Advanced Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia
3. Imatinib Mesylate in Treating Patients With Myelofibrosis
4. VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia
5. Tipifarnib in Treating Patients With Myelodysplastic Syndrome
Related Studies:
Other Chronic Myelomonocytic Leukemia Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome
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