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Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma Clinical research trials and Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma. Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma clinical trial. Human subjects often receive the most effective healthcare possible for their Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma  Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma
Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma
For Condition: Leukemia,Lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Massey Cancer Center
Synopsis: RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Eliminating the T cells from the donor cells before transplanting them may prevent this from happening. PURPOSE: Randomized phase II/III trial to compare the effectiveness of conventional bone marrow transplantation with T cell-depleted bone marrow transplantation in treating patients who have leukemia, myelodysplasia, or lymphoblastic lymphoma.
Details: OBJECTIVES: I. Compare the disease free survival of patients with leukemia, myelodysplasia, or lymphoblastic lymphoma after treatment with conventional (non-T cell depleted) or T cell depleted unrelated donor bone marrow transplantation. II. Compare the incidence of primary and secondary graft failure, acute and chronic graft-vs-host disease, complications (infection, veno-occlusive disease, interstitial pneumonitis), and relapse in these patients after these treatments. III. Compare the incidence of other malignancies, lymphoproliferative disorders, and post-transplant myelodysplasia in these patients after these treatments. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients will be stratified according to institution. Patients are assigned to one of two treatment arms, one with conventional bone marrow transplantation (arm I) and one with T cell depletion of the bone marrow (arm II). Arm I: Patients receive cyclophosphamide on days -6 and -5. Total body irradiation (TBI) is administered on days -4 to 0, although this order may be reversed. Males with ALL receive a testicular boost of radiation therapy. Bone marrow is infused on day 0. Patients receive cyclosporine beginning on day -1 and methotrexate IV on days 1, 3, 6, and 11. Arm II: T cell depletion is conducted by 2 different methods, according to the institution, and treatment varies depending on the method used. Method I is by T10B9 depletion and Method II is by counterflow elutriation depletion. Method I: Depending on the institution, some patients receive TBI on days -9 to -7 (before chemotherapy) (Course I) and some receive TBI on days -3 to -1 (after chemotherapy) (Course II). Course I also includes cytarabine IV on days -5 to -3, cyclophosphamide IV on days -2 and -1, and methylprednisolone IV on days -2 to 0 and 5-18. Bone marrow infusion is administered on day 0. Cyclosporine begins on day -1. Course II includes cytarabine IV on days -7 to -4 and cyclophosphamide on days -6 to -5. Methylprednisolone IV is administered on days -2 to 0 and 5-18. Bone marrow infusion is administered on day 0. Cyclosporine begins on day 0. Method II: Preparative therapy varies according to the disease category. Acute lymphoblastic leukemia: Patients undergo TBI on days -7 to -4. Males receive testicular boost on day -7, and all receive electron boost to anterior and posterior chest wall on days -5 and -4. Cyclophosphamide IV is administered on days -3 and -2. Bone marrow infusion is administered on day 0. Acute nonlymphocytic leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome: Patients receive cyclophosphamide IV on days -7 and -6, followed by TBI on days -4 to -1. Bone marrow infusion is administered on day 0. Patients receive methylprednisolone IV every 12 hr on days -2,-1, and 5-19. Cyclosporine is administered from day -3 to day 180. All patients on both arms receive filgrastim (granulocyte colony-stimulating factor; G-CSF) beginning on day 7 post-transplant. Patients are followed weekly for the first 14 weeks, at day 100, every 6 months for 2 years, then annually thereafter. PROJECTED ACCRUAL: A total of 560 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /55 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Pathologically confirmed acute myeloid leukemia; Not in first complete remission with translocations t(8;21) unless failed first line induction therapy; Not in first complete remission with translocations t(15;17) or 16q abnormality unless: Failed first line induction therapy OR Molecular evidence of disease - Pathologically confirmed acute lymphoblastic lymphoma (ALL); Not in first complete remission OR High risk ALL in first complete remission defined as: Hypodiploidy OR Pseudodiploidy with translocations t(9,22), t(4;11), or t(8;14) OR Elevated WBC at presentation; Greater than 100,000/mm3 if 6-12 months old; Greater than 50,000/mm3 if 10-20 years old; Greater than 20,000/mm3 if 21 or over OR Failed to achieve complete remission after 4 weeks of induction therapy - Pathologically confirmed chronic myelogenous leukemia (CML) not in blast crisis - Pathologically confirmed undifferentiated leukemia or biphenotypic leukemia - Pathologically confirmed juvenile CML with or without either 7q- or infantile monosomy 7; Leukocytosis with absolute monocytosis greater than 450 microliters AND Immature myeloid cells in peripheral blood circulation Less than 25% marrow blasts - Myelodysplastic syndromes: Refractory anemia (RA) RA with ringed sideroblasts RA with excess blasts (RAEB); RAEB in transformation; Chronic myelomonocytic leukemia - Pathologically confirmed stage IV lymphoblastic lymphoma - No active CNS or skin leukemic involvement - No consenting suitably HLA-matched related donor available - Consenting unrelated donor available --Prior/Concurrent Therapy-- - Biologic therapy: No prior autologous or allogeneic bone marrow transplant - Chemotherapy: See Disease Characteristics - Endocrine therapy: Not specified - Radiotherapy: No concurrent mediastinal radiation; No prior radiation therapy that would preclude total body irradiation - Surgery: Not specified --Patient Characteristics-- - Age: 55 and under - Performance status: Karnofsky 70-100% OR Lansky 60-100% - Life expectancy: Not specified - Hematopoietic: See Disease Characteristics - Hepatic: Bilirubin less than 2.5 mg/dL; SGOT less than 3 times upper limit of normal - Renal: Creatinine within normal range OR Creatinine clearance greater than 60 mL/min - Cardiovascular: Asymptomatic OR Left ventricular ejection fraction at rest greater than 40% and improves with exercise - Pulmonary: Asymptomatic OR DLCO greater than 45% - Other: Not pregnant or lactating; HIV negative; No uncontrolled viral, bacterial, or fungal infection
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LeeJensen, Study Chair, Massey Cancer Center
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
United States
University of South Carolina School of Medicine
Columbia, South Carolina, 29203
United States
Additional Information:
Study ID Numbers: CDR0000066016; MCV-CCHR-9504-2X,NCI-G98-1388,DUMC-75951
Study Start Date: April 2000
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003187
Other Lymphoma Studies:
1. Evaluation and Natural History of Children with Cancer and AIDS
2. Treating High Risk Leukemia with CD40 Ligand & IL-2 Gene Modified Tumor Vaccine.
3. Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
4. Chemotherapy Plus Donor White Blood Cell Infusion in Treating Patients With Relapsed Hematologic Cancer Following Donor Peripheral Stem Cell Transplantation
5. ZD0473 and Doxorubicin in Treating Patients With Advanced Solid Tumors or Lymphoma
Related Studies:
Other Lymphoma Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma
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