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Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission Clinical research trials and Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission. Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission clinical trial. Subjects frequently get the best healthcare possible for their Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission  Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission
Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission
For Condition: childhood acute myeloid leukemia in remission,adult acute lymphoblastic leukemia in remission,recurrent adult acute myeloid leukemia,adult acute myeloid leukemia in remission,acute undifferentiated leukemia,recurrent childhood acute myeloid leukemia,recurrent adult acute lymphoblastic leukemia,recurrent childhood acute lymphoblastic leukemia,childhood acute lymphoblastic leukemia in remission
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of bone marrow transplantation using untreated or treated bone marrow in treating patients with acute leukemia in first or second remission.
Details: OBJECTIVES: I. Compare the efficacy of T-cell-depleted vs unmodified allogeneic marrow rescue with regard to disease-free survival, post-transplantation leukemic relapse rate, incidence and severity of graft-versus-host disease, quality of engraftment and hematopoietic reconstitution, and immunoreconstitution following transplantation in patients with acute leukemia in first or second remission. PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to disease (acute lymphocytic leukemia (ALL) vs acute myeloid leukemia (AML), and age (20 and under vs over 20). Patients are randomized to one of two treatment arms. Patients under age 5 are nonrandomly assigned to Arm I and those over age 55 are nonrandomly assigned to Arm II. Arm I: Patients receive total body radiotherapy on days -7 through -4 followed by cyclophosphamide IV on days -3 and -2. Patients undergo allogeneic bone marrow transplantation (ABMT) IV over 2-4 hours on day 0. Patients also receive standard graft vs host disease prophylaxis with cyclosporine and methotrexate. Arm II: Patients receive total body radiotherapy on days -9 through -6, thiotepa IV on days -5 and -4, and cyclophosphamide as in Arm I. Patients undergo T-cell depleted ABMT IV over 15 minutes on day 0. Patients over age 15 receiving bone marrow from female donors over age 30 or from male donors of any age also receive graft rejection prophylaxis consisting of antithymocyte globulin IV over 6-8 hours on days -5 and -4 and oral methylprednisolone twice daily on days -5 and -4. Beginning 2 months following transplantation, adult patients with AML and a prior history of CNS disease, all adult patients with ALL, and all pediatric patients (ALL and ANLL) receive CNS leukemia prophylaxis with cytarabine intrathecally with the diagnostic lumbar puncture and then monthly for 5 months (1 year in patients with a prior history of CNS leukemia). PROJECTED ACCRUAL: A total of 128 patients will be randomized. At an anticipated accrual rate of 35 patients/year, accrual is expected to be completed in 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Acute leukemias in the following categories: Histologically documented ANLL in first remission (CR1) or second remission (CR2); Pediatric ANLL patients in CR1 eligible provided they are not enrolled on protocol CCG-2891; ALL in CR1 presenting with at least 1 of the following high-risk features: WBC at presentation greater than 50,000/mm3 (200,000/mm3 in pediatric patients) Hypoploidy as measured by flow cytometry; Pseudodiploidy with translocations t(9;22), t(4;11), and t(8;14); CR not achieved until after 4 weeks of induction therapy; ALL in CR2 that has relapsed in the bone marrow following a first remission regardless of time of relapse; Acute biphenotypic leukemia (mixed myeloid and lymphoid lineage at presentation) in CR1 or CR2, i.e., patients classified as lymphoblastic or myeloblastic based on FAB morphology and histochemistry features; Adult acute undifferentiated leukemia (no evidence of lymphoid or myeloid differentiation) and in CR1 or CR2; Patients in this category are analyzed separately; CR defined as no evidence of leukemia at time of transplantation as documented by normocellular bone marrow aspirate containing no more than 5% blasts no more than 2 weeks prior to cytoreduction - Normal diagnostic LP or Ommaya reservoir tap required no more than 2 weeks prior to start of cytoreduction in all ALL patients and in ANLL patients at risk for CNS disease - No extramedullary disease at time of transplantation - HLA-identical, MLC-compatible related donor required Donor must be healthy and willing to undergo general anesthesia and donation procedure - For T-cell depletion, donor should be able to have a volume of 15 ml/kg patient body weight harvested safely --Prior/Concurrent Therapy-- - See Disease Characteristics --Patient Characteristics-- - Age: Any age (5 to 55 to be eligible for randomization) - Performance status: Karnofsky (or Lansky) 70-100% - Life expectancy: Greater than 8 weeks - Hematopoietic: See Disease Characteristics - Hepatic: Bilirubin less than 1.5 mg/dl; SGOT no greater than 3 times upper limit of normal (ULN) (both parameters stable for at least 4 weeks prior to transplantation) - Renal: Creatinine less than 2 times ULN and stable for at least 4 weeks prior to transplantation OR Creatinine clearance at least 70 mL/min - Cardiovascular: Fractional shortening greater than 28% on echocardiogram (23-28% if FS increases as a response to stress on supine bicycle ergometer); LVEF at least 50% on echocardiogram or MUGA - Other: In good clinical condition at time of transplantation with no medical problems that would significantly increase the risk of the procedure; No infection at time of transplantation; Not pregnant or nursing
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FaridBoulad, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000078464; MSKCC-93045,NCI-H93-0293
Study Start Date: May 1993
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002534
Other Childhood Acute Myeloid Leukemia In Remission Studies:
1. Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission
2. Docetaxel in Treating Children With Relapsed or Refractory Acute Lymphoblastic or Acute Myeloid Leukemia
3. 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
4. Detection of Residual Disease in Children Receiving Therapy for Acute Myeloid Leukemia or Myelodysplastic Syndrome
5. Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia
Related Studies:
Other childhood acute myeloid leukemia in remission Clinical Trials
Other New York Clinical Trials
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Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission
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