CINJALL: Treatment for Children With Acute Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT00176462|
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : June 9, 2014
Last Update Posted : June 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphocytic Leukemia||Drug: aminopterin Drug: L-asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunomycin Drug: dexamethasone Drug: 6-mercaptopurine Drug: methotrexate Drug: 6-thioguanine Drug: vincristine Drug: Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone) Drug: Leucovorin||Phase 2|
Outline of Therapy:
Combinations of chemotherapy drugs will be given orally, intravenously and intrathecally (directly into the cerebrospinal fluid by spinal tap) over a period of roughly two and a half years.
Therapy will be divided into five phases:
Induction (4 weeks): chemotherapy given to produce a clinical remission (defined by normal blood counts, with the absence of leukemia cells in the blood and fewer than 5% leukemia cells in the bone marrow).
Consolidation (11 weeks): chemotherapy given to consolidate the remission. Delayed Intensification (7 weeks) Intensive chemotherapy aimed at killing any resistant leukemia cells will be given only for patients at high risk of relapse.
Intensive Continuation (approximately 1 year): Eight week cycles of chemotherapy, given eight times.
Continuation (final year of therapy): Eight week cycles of largely oral chemotherapy, with one clinic visit for a lumbar puncture every eight weeks.
Irradiation: radiation will be given in the middle of intensive continuation to the head and spine of those patients who have leukemia cells found in the cerebrospinal fluid at the time of diagnosis.
Follow-up: After the conclusion of therapy, there will be periodic office visits, initially monthly, then gradually spaced out to annual visits. The purpose of these visits is to evaluate for late side-effects of therapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||CINJALL: Treatment for Children With Acute Lymphocytic Leukemia|
|Study Start Date :||February 2001|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
Experimental: Arm 1 Standard Risk
6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and ContinuationDrug: daunomycin
Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and ContinuationDrug: dexamethasone
Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and ContinuationDrug: 6-mercaptopurine
Experimental: Arm 2 High Risk
6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
- Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years [ Time Frame: 5 years ]This measure looks at the percentage of patients on Arm 2 who did not experience a relapse at 5 years, where relapse is defined as the presence of progressive disease after the achievement of a complete remission.
- To Measure 5-methyltetrahydrofolate, Aminopterin and Methotrexate Uptake in Leukemic Blasts Isolated at Diagnosis [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00176462
|United States, New Jersey|
|Jersey Shore University Medical Center|
|Neptune, New Jersey, United States, 07754|
|Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||Barton Kamen, MD||Rutgers, The State University of New Jersey|