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Home > "C" Clinical Trials Conditions > Comparison of Different Combination Chemotherapy Regimens in Treating Infants With Acute Lymphoblastic Leukemia  Comparison of Different Combination Chemotherapy Regimens in Treating Infants With Acute Lymphoblastic Leukemia
Comparison of Different Combination Chemotherapy Regimens in Treating Infants With Acute Lymphoblastic Leukemia
For Condition: untreated childhood acute lymphoblastic leukemia
Status: Recruiting
Sponsor(s): International Coordination Unit ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapyregimen is most effective for treating infants with acute lymphoblastic leukemia. PURPOSE: Randomizedphase III trial to compare the effectiveness of different combination chemotherapy regimens in treating infants who have newly diagnosed acute lymphoblastic leukemia.
Details: OBJECTIVES: - Determine the outcome of induction chemotherapy followed by consolidation and reinduction chemotherapy with or without late intensification chemotherapy followed by a maintenance regimen or allogeneic bone marrow transplantation in infants with newly diagnosed acute lymphoblastic leukemia. - Determine the value of a late intensification course between reinduction and maintenance therapy in these patients. - Determine the prognostic value of age, immunophenotype, WBC, day 15 bone marrow status, and MLL gene rearrangement in patients treated with these regimens. OUTLINE: This is a partially randomized, multicenter study. Patients are stratified according to risk (high vs standard). Patients receive induction therapy comprising prednisone orally or IV three times a day on days 1-7; dexamethasone orally or IV three times a day on days 8-35; vincristine IV on days 8, 15, 22, and 29; cytarabine IV over 30 minutes on days 8-21; daunorubicin IV over 60 minutes on days 8 and 9; asparaginase IV over 1 hour or intramuscularly (IM) on days 15, 18, 22, 25, 29, and 33; methotrexate intrathecally (IT) on days 1 and 29; and cytarabine IT on day 15. Patients receive prednisolone IT in combination with any dose of intrathecal chemotherapy. Patients with CNS involvement receive additional doses of methotrexate IT on days 8 and 22 and then weekly after day 29 until there is no evidence of CNS leukemia. After achieving complete remission, patients receive MARAM chemotherapy comprising oral mercaptopurine daily on days 1-14; methotrexate IV over 24 hours on days 1 and 8; leucovorin calcium orally or IV 36, 42, and 48 hours after beginning each dose of oral methotrexate; methotrexate IT on days 2 and 9; cytarabine IV over 3 hours twice daily on days 15, 16, 22, and 23; and asparaginase IV over 1 hour or IM on days 16 and 23. Patients receive prednisolone IT in combination with any dose of intrathecal methotrexate. At least 2 weeks after the completion of MARAM chemotherapy, patients receive OCTADD chemotherapy comprising oral dexamethasone three times a day on days 1-21; oral thioguanine daily on days 1-28 and 36-49; vincristine IV on days 1, 8, 15, and 22; daunorubicin IV over 60 minutes on days 1, 8, 15, and 22; cytarabine IV on days 2-5, 9-12, 16-19, 23-26, 37-40, and 45-48; cytarabine IT on days 1 and 15; and cyclophosphamide IV over 1 hour on days 36 and 49. Patients receive prednisolone IT in combination with any dose of intrathecal methotrexate. Patients are randomized to one of two treatment arms for late intensification therapy. - Arm I: Beginning at least 1 week after the completion of OCTADD chemotherapy, patients receive VIMARAM chemotherapy comprising vincristine IV on days 1, 8, 15, and 22; oral mercaptopurine daily on days 1-14; methotrexate IV over 24 hours on days 1 and 8; leucovorin calcium orally or IV 36, 42, and 48 hours after the beginning of each dose of oral methotrexate; methotrexate IT on days 2 and 9; cytarabine IV over 3 hours twice daily on days 15, 16, 22, and 23; and asparaginase IV over 1 hour or IM on days 16 and 23. Patients receive prednisolone IT in combination with any dose of intrathecal methotrexate. Patients then receive the appropriate maintenance therapy. - Arm II: Patients do not receive VIMARAM chemotherapy but receive appropriate maintenance therapy. At least 2 weeks after the completion of the last course of chemotherapy, patients receive maintenance therapy. Patients with a good response to initial therapy with prednisone receive maintenance therapy comprising oral dexamethasone three times daily on weeks 1 and 2; vincristine IV on day 2 of weeks 1 and 2; oral mercaptopurine daily on weeks 1-14; and oral methotrexate once weekly on weeks 1-14. Patients with a poor response to initial therapy with prednisone receive maintenance therapy comprising oral mercaptopurine daily for weeks 1-14; oral methotrexate once weekly for weeks 1-14; oral dexamethasone three times daily for weeks 1 and 2; vincristine IV on day 1 of weeks 1 and 2; etoposide IV over 2 hours once weekly on weeks 8 and 9; and cytarabine IV over 1 hour once weekly on weeks 8 and 9. Treatment repeats in both maintenance therapy regimens every 14 weeks for a total of 3 courses. Patients also receive methotrexate IT on day 1 of the first and third course of therapy and cytarabine IT on day 1 of the second course of therapy. Patients receive prednisolone IT in combination with any dose of intrathecal chemotherapy. Beginning after the completion of maintenance therapy, all patients receive continuing maintenance therapy comprising oral mercaptopurine daily and oral methotrexate once a week. Treatment continues until 104 weeks after initial diagnosis. Patients with a poor response to initial therapy with prednisone may receive allogeneic bone marrow transplantation if a donor is available. The patient undergoes transplantation immediately after OCTADD chemotherapy rather than being randomized and receiving maintenance therapy. These patients receive conditioning regimen comprising oral busulfan four times a day on days -8 to -5, etoposide IV over 4 hours on day -4, methotrexate IT on day -3, and cyclophosphamide IV over 1 hour on days -3 and -2. Allogenic bone marrow is transplanted on day 0. Patients then receive cyclosporine orally or IV on days 1-180 as graft-versus-host disease prophylaxis. Patients are followed annually. PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /1 Year
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of acute lymphoblastic leukemia (ALL) - Newly diagnosed - Morphological verification by cytochemistry and immunophenotyping - CNS or testicular leukemia at diagnosis allowed - Trisomy 21 allowed PATIENT CHARACTERISTICS: Age: - 365 days or less Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for leukemia Endocrine therapy: - At least 4 weeks since prior systemic corticosteroids - Prior inhaled steroids allowed Radiotherapy: - No prior radiotherapy for leukemia Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobPieters, Study Chair, Sophia Children's Hospital
Ostra Sjukhuset *Recruiting*
Gothenburg (Goteborg), , 41685
Sweden
Recruiting L. Mellander 46-31-374-000
Hopital Universitaire Des Enfants Reine Fabiola *Recruiting*
Brussels, , 1020
Belgium
Recruiting Alice Ferster 32-2-477-2678
Institute of Child Health *Recruiting*
London, , WC1N 1EH
United Kingdom
Recruiting Judith Chessells 44-171-813-8192
Sophia Children's Hospital *Recruiting*
Rotterdam, , 3015 GJ
Netherlands
Recruiting Rob Pieters 31-10-4636691
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting Jeffrey Rubnitz 901-495-2388
Nuovo Ospedale San Gerardo *Recruiting*
Monza, , 20052
Italy
Recruiting Andrea Biondi 39-039-233-3661
Medizinische Hochschule Hannover *Recruiting*
Hannover, , D-30625
Germany
Recruiting Martin Schrappe 49-511-532-6713
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Lewis Silverman 617-632-5285
St. Anna Children's Hospital *Recruiting*
Vienna, , A-1090
Austria
Recruiting Helmut Gadner 43-1-401-70-250
Universitaets-Krankenhaus Eppendorf *Recruiting*
Hamburg, , D-20246
Germany
Recruiting Gritta Janka-Schaub 040-4717-2580
Ospedale San Gerardo *Recruiting*
Monza, , 20052
Italy
Recruiting M.G. Valsecchi 39-039-233-3074
University Hospital Motol *Recruiting*
Prague, , 150 06
Czech Republic
Recruiting J. Stary 00-420-2-2443-2200
Hopital Saint-Louis *Recruiting*
Paris, , 75475
France
Recruiting T. Leblanc 33-1-42-499-721
Additional Information:
Study ID Numbers: CDR0000068529; ICU-INTERFANT99,EU-20063
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00015873
Other Untreated Childhood Acute Lymphoblastic Leukemia Studies:
1. Hormone Therapy Plus Chemotherapy in Treating Children With Acute Lymphocytic Leukemia
2. Genetic Study of Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndromes
3. Combination Chemotherapy With or Without Donor Bone Marrow Transplantation in Treating Infants With Previously Untreated Acute Lymphoblastic Leukemia
4. Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
5. Comparison of Different Combination Chemotherapy Regimens in Treating Infants With Acute Lymphoblastic Leukemia
Related Studies:
Other untreated childhood acute lymphoblastic leukemia Clinical Trials
Other Clinical Trials
Other Monza Clinical Trials
Comparison of Different Combination Chemotherapy Regimens in Treating Infants With Acute Lymphoblastic Leukemia
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