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Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia Clinical research trials and Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia healthcare trials take place in many of cities 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 evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia. Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia  Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia
Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia
For Condition: Myeloid Leukemia,Neutropenia
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. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. 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 different treatment regimens in treating patients who have acute myeloid leukemia.
Details: OBJECTIVES: I. Compare the remission rate, duration of remission, survival, toxicity, and supportive care requirements associated with induction chemotherapy with cytarabine, daunorubicin, and etoposide vs mitoxantrone, cytarabine, and etoposide in patients with acute myeloid leukemia. II. Assess filgrastim (G-CSF) support in the recovery phase after the first induction course with respect to remission rate, reasons for failure, hematologic regeneration, febrile incidents, supportive care requirements, and overall survival in these patients. III. Compare 4 vs 5 courses of total treatment, with either chemotherapy or bone marrow transplantation (BMT) as the final course, with respect to remission duration, relapse rate, disease free mortality, and overall survival in these patients. IV. Compare allogeneic or autologous BMT vs conventional chemotherapy with respect to remission duration, relapse rate, disease free mortality, and overall survival in these patients. V. Evaluate the prognostic significance of blood and bone marrow morphology, cytogenetics, molecular genetics, and immunophenotype assessed at diagnosis, at second randomization, and at relapse. PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by center, age (15-29 vs 30-39 vs 40-49 vs 50-59), performance status, and disease status (de novo vs secondary). Patients who are eligible for the second randomization are also stratified by first randomization treatment (arm I vs II) and prognostic risk group (good vs standard). Original first randomization (closed as of 11/1998): Patients are randomized to 1 of 2 induction treatment arms. Arm I: During course 1, patients receive cytarabine IV every 12 hours on days 1-10, daunorubicin IV on days 1, 3, and 5, and etoposide IV over 1 hour on days 1-5. Patients are further randomized to receive either filgrastim (G- CSF) or placebo subcutaneously (SQ) beginning on day 18 and continuing until 2 days after blood counts have recovered (G-CSF randomization closed as of 8/15/2000). During course 2, patients receive daunorubicin and etoposide as in course 1 and cytarabine IV every 12 hours on days 1-8, but no G-CSF or placebo unless peripheral blood stem cells (PBSC) are harvested. Arm II: During course 1, patients receive mitoxantrone IV on days 1, 3, and 5 and cytarabine, etoposide, and G-CSF or placebo as in course 1 of arm I. During course 2, patients receive mitoxantrone and etoposide as in course 1 of arm II, cytarabine as in course 2 of arm I, but no G-CSF or placebo unless PBSC are harvested. Patients who have poor prognostic risk after course 1 or fail to achieve complete remission (CR) after course 2 are taken off this study and should be entered in the MRC refractory/relapse study. Patients who achieve CR after course 1 proceed to the harvest phase after completion of course 2. Patients who achieve CR after course 2 proceed to the postinduction chemotherapy phase. New first randomization (opened as of 12/1998): Patients are randomized to 1 of 2 induction treatment arms. Arm I: During course 1, patients receive daunorubicin IV on days 1, 3, and 5 and lower dose cytarabine IV every 12 hours and thioguanine IV every 12 hours on days 1-10. During course 2, patients receive treatment as in course 1, but with cytarabine and thioguanine on days 1-8. Arm II: During courses 1 and 2, patients receive treatment as in arm I, but with higher dose cytarabine. Both arms may be further randomized to receive no tretinoin or tretinoin for 60 days. Acute prophylactic subgroups are not randomized and all receive tretinoin. Postinduction chemotherapy: Patients receive amsacrine IV over 1 hour, cytarabine IV continuously, and etoposide IV over 1 hour on days 1-5. Harvest: Patients who have an HLA matched sibling donor undergo allogeneic bone marrow transplantation (BMT), otherwise autologous BMT is planned. PBSC may also be harvested. Patients who undergo harvest of PBSC also receive G-CSF on days 18-30 of induction and days 13-25 of postinduction. Second randomization: Patients are randomized to 1 of 4 consolidation treatment groups. Good risk patients are randomized to arm II or IV. Standard risk patients for whom BMT is considered inappropriate are randomized to arm II or IV and those for whom BMT is considered appropriate are randomized to arm I or III. Patients for whom 4 total courses of therapy are preferred are randomized to arm I or II and those for whom 5 total courses of therapy are preferred are randomized to arm III or IV. Arm I: Six to eight weeks following completion of induction, patients receive a fourth course of therapy comprised of cyclophosphamide IV over 1 hour for 2 days, followed 24 hours later by total body irradiation (TBI) for 4 days, and followed 24 hours later by reinfusion of bone marrow. Patients receive cranial irradiation daily for 3-5 days prior to TBI. Arm II: Patients receive a fourth course comprised of mitoxantrone IV on days 1-5 and cytarabine IV over 2 hours every 12 hours on days 1-3. Arm III: Patients receive a fourth course comprised of idarubicin IV on days 1 and 2, cytarabine as in arm II, and etoposide IV over 1 hour on days 1-3 and then a fifth course comprised of cranial irradiation, TBI, and BMT as in arm I. Arm IV: Patients receive a 4th course comprised of idarubicin, cytarabine, and etoposide as in arm III and then a 5th course comprised of mitoxantrone and cytarabine as in arm II. PBSC support: Optional PBSC are reinfused after completion of course 4 (arm I or II) or course 5 (arm III or IV) beginning no sooner than 24 hours after completion of BMT. CNS therapy: Patients receive cytarabine intrathecally at the time of diagnostic lumbar puncture, then 3 days a week until cerebral spinal fluid clears, and then every 2 weeks until completion of consolidation. PROJECTED ACCRUAL: A minimum of 2,000 patients will be accrued for 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-- De novo or secondary acute myeloid leukemia of any morphologic type - Acute promyelocytic leukemia also entered on MRC ATRA trial - No blastic transformation of chronic myeloid leukemia --Prior/Concurrent Therapy-- No prior cytotoxic chemotherapy for leukemia --Patient Characteristics-- Age: - 15 to physiologic 59 - Patients for whom intensive therapy is considered inappropriate may be entered on protocol MRC-LEUK-AML11 or its successor Performance status: Any status Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: - No concurrent active malignancy - Not pregnant or nursing
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlanBurnett, Study Chair, Medical Research Council
University of Wales College of Medicine
Cardiff, Wales, CF14 4XN
United Kingdom
Additional Information:
Study ID Numbers: CDR0000064208; MRC-LEUK-AML12,EU-95001
Study Start Date: January 1994
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002658
Other Neutropenia Studies:
1. Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome
2. Tipifarnib in Treating Patients With Advanced Hematologic Cancer
3. Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
4. Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia
5. Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
Related Studies:
Other Neutropenia Clinical Trials
Other Wales Clinical Trials
Other Cardiff Clinical Trials
Combination Chemotherapy, Biological Therapy, and Bone Marrow Transplantation in Treating Patients With Acute Myeloid Leukemia
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