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Home > "B" Clinical Trials Conditions > Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

Bone Marrow Transplantation in Treating Patients With Hematologic Cancer



Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

For Condition: Lymphoma,Leukemia,Multiple Myeloma
Status: No longer recruiting
Sponsor(s): University of Maryland Greenebaum Cancer Center ,
Synopsis: RATIONALE: Bone marrow that has been treated to remove certain white blood cells may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy, and may reduce the chance of developing graft-versus-host disease following bone marrow transplantation. PURPOSE: Phase IV trial to study the incidence of graft-versus-host disease in patients who have hematologic cancer and who are undergoing bone marrow transplantation from a donor.
Details: OBJECTIVES: I. Evaluate the incidence of acute graft versus host disease in patients undergoing transplantation with an unrelated or related matched or mismatched antigen donor. II. Evaluate the rapidity of engraftment and CD4 count recovery post-transplantation in this patient population. PROTOCOL OUTLINE: Patients receive total body irradiation (TBI) three or two times a day on days -8 to -5. Following TBI, patients receive thiotepa IV over 4 hours daily on days -4 and -3 plus cyclophosphamide IV over 1 hour daily on days -2 and -1. Antithymocyte globulin is administered by IV over at least 4 hours on days -4 to -1. Patients undergo an allogenic bone marrow transplantation on day 0. Bone marrow is harvested from patient's donor, depleted of T-cells, and infused. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4. PROJECTED ACCRUAL: Approximately 26-45 patients will be accrued for this study within 3-4 years.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /50 Years
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven malignancy or condition of the following types: Acute myelogenous leukemia (not M5 or M6) or lymphocytic leukemia in first or greater remission or early relapse OR Chronic myelogenous leukemia OR Myelodysplastic syndrome OR Aggressive or refractory non-Hodgkin's lymphoma OR Aggressive or refractory Hodgkin's disease OR Multiple myeloma at early relapse or after conventional chemotherapy to reduce tumor mass OR High risk chronic lymphocytic leukemia OR Aplastic anemia - HLA-matched or 1 antigen mismatched (related or unrelated) available as donor --Prior/Concurrent Therapy-- - See Disease Characteristics --Patient Characteristics-- - Age: 50 and under - Performance status: Karnofsky 70-100% - Life expectancy: Greater than 8 weeks - Hematopoietic: Not specified - Hepatic: Bilirubin less than 2 mg/dL; SGOT less than 4 times upper limit of normal (ULN) - Renal: Creatinine less than 2 times ULN OR Creatinine clearance greater than 60 mL/min - Cardiovascular: LVEF at least 50% by MUGA - Pulmonary: DLCO at least 50% - Other: HIV negative; No active extramedullary disease; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
BarryMeisenberg,  Study Chair,  University of Maryland Greenebaum Cancer Center

Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore,  Maryland,  21201
United States
 


Additional Information:
Study ID Numbers:  CDR0000066400;  MSGCC-9739,NCI-V98-1433
Study Start Date: September 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003398

Other Multiple Myeloma Studies:
1. CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects with Multiple Myeloma

2. Total Therapy II

3. Anti-Angiogenesis Therapy Using Thalidomide in Multiple Myeloma

4. Xcellerated T CellsTM in Patients with Multiple Myeloma

5. Stem Cell Transplantation in Treating Patients with Hematologic Cancer

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