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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myeloid Leukemia  Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myeloid Leukemia
Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myeloid Leukemia
For Condition: untreated childhood acute myeloid leukemia and other myeloid malignancies,de novo myelodysplastic syndromes,childhood acute promyelocytic leukemia (M3),refractory anemia with excess blasts in transformation,refractory anemia with excess blasts,secondary acute myeloid leukemia,secondary myelodysplastic syndromes
Status: No longer recruiting
Sponsor(s): Medical Research Council ,
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 doctors to give higher doses of chemotherapy and kill more cancer cells. It is not yet known whether chemotherapy is more effective with or without bone marrow transplantation for acute myeloid leukemia. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without bone marrow transplantation in treating children who have acute myeloid leukemia.
Details: OBJECTIVES: I. Compare two induction schedules with respect to achievement and duration of remission, survival, toxicity, and supportive care requirements in children with previously untreated acute myeloid leukemia. II. Compare 4 versus 5 courses of treatment in total (where the final course is either chemotherapy or bone marrow transplantation) with respect to remission duration, relapse rates, deaths in remission, and overall survival in these patients. III. Compare the value of allogeneic bone marrow transplantation versus conventional chemotherapy with respect to remission duration, relapse rates, deaths in remission, and overall survival in these patients. IV. Reduce toxicity without compromising survival by restricting the number of patients receiving bone marrow transplant in this study. PROTOCOL OUTLINE: This is a randomized study. Patients are first randomized to one of two treatment arms. Patients in arm I receive 2 courses of cytarabine IV push every 12 hours on days 1-10 or 1-8 (20 or 16 doses); daunorubicin IV over 6 hours on days 1, 3, and 5; and etoposide IV over 4 hours on days 1-5 (5 doses). Patients in arm II receive 2 courses of mitoxantrone IV over 6 hours on days 1, 3, and 5; cytarabine IV push every 12 hours on days 1-10 or 1-8 (20 or 16 doses); and etoposide IV over 4 hours on days 1-5 (5 doses). Patients with no CNS disease at diagnosis receive 3 courses of triple intrathecal therapy (methotrexate, cytarabine, and hydrocortisone), one after each of the first 3 courses of chemotherapy. Patients with CNS disease receive at least 6 courses of intrathecal therapy (2 courses per week), then monthly courses until the final course of chemotherapy is complete. Patients in complete response after course 2 continue on this study. Patients not in complete response after course 2 are taken off study and are eligible for the current Medical Research Council (MRC) refractory/relapse study or another therapy. All patients continuing on this study receive amsacrine IV over 1 hour daily on days 1-5, cytarabine continuous IV infusion daily on days 1-5, and etoposide IV over 4 hours on days 1-5 as course 3. After course 3, patients are assigned to two risk groups: good risk patients, and standard and poor risk patients. Standard and poor risk patients with no matched sibling donor and good risk patients are then further randomized to receive mitoxantrone IV over 6 hours on days 1-5 and cytarabine IV over 2 hours every 12 hours on days 1-3 (4 courses of chemotherapy total; arm I) or cytarabine IV over 3 hours every 12 hours on days 1, 2, 8, and 9, and asparaginase subcutaneous infusion 3 hours after completion the last cytarabine doses on days 2 and 9, followed by a course of mitoxantrone and cytarabine, as in arm I (5 courses of chemotherapy total; arm II). Standard and poor risk children with matched sibling donor are randomized to receive either no consolidation treatment (3 courses of chemotherapy total) plus bone marrow transplantation (arm III) or cytarabine and asparaginase as described above (4 courses of chemotherapy total) plus bone marrow transplantation (arm IV). Patients are followed for at least 1 year. PROJECTED ACCRUAL: Approximately 2,000 patients will be accrued into this study over 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /15 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed de novo or secondary acute myeloid leukemia (AML) OR Aggressive myelodysplastic syndromes (refractory anemia with excess blasts (RAEB) and RAEB in transformation) for which intensive AML therapy is considered appropriate OR Acute promyelocytic leukemia (should also be entered into protocol MRC-ATRA) - No chronic myeloid leukemia in blast transformation - Must be considered suitable for intensive chemotherapy --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy for leukemia - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified --Patient Characteristics-- - Age: Under 16 - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Other: No other concurrent active malignancy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
OsbornEden, Study Chair, Medical Research Council
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
United Kingdom
Additional Information:
Study ID Numbers: CDR0000066463; MRC-LEUK-AML12CH,EU-98010
Study Start Date: July 1998
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003436
Other Childhood Acute Promyelocytic Leukemia (m3) Studies:
1. Genetic Study of Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndromes
2. Tretinoin, Cytarabine, and Daunorubicin With or Without Arsenic Trioxide Followed by Tretinoin With or Without Mercaptopurine and Methotrexate in Treating Patients With Acute Promyelocytic Leukemia
3. Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myeloid Leukemia
Related Studies:
Other childhood acute promyelocytic leukemia (M3) Clinical Trials
Other England Clinical Trials
Other Manchester Clinical Trials
Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myeloid Leukemia
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