Combination Chemotherapy Plus Steroid Therapy in Treating Children With Acute Lymphoblastic Leukemia or Lymphoblastic Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00003728|
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : January 21, 2011
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy plus steroid therapy is more effective for acute lymphoblastic leukemia or lymphoblastic non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy plus steroid therapy in treating children who have acute lymphoblastic leukemia or lymphoblastic non-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma||Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: methylprednisolone Drug: mitoxantrone hydrochloride Drug: prednisolone Drug: therapeutic hydrocortisone Drug: thioguanine Drug: vincristine sulfate Drug: vindesine Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Official Title:||The Value of Dexamethasone Versus Prednisolone During Induction and Maintenance Therapy of Prolonged Versus Conventional Duration of L-Asparaginase Therapy During Consolidation and Late Intensification, and of Corticosteroid + VCR Pulses During Maintenance in Acute Lymphoblastic Leukemia and Lymphoblastic Non-Hodgkin Lymphoma of Childhood|
|Study Start Date :||December 1998|
|Estimated Primary Completion Date :||May 2008|
- Event-free survival after first randomization
- Disease-free survival after second and third randomization
- Overall survival
- Response to prephase as assessed by number of blasts/mm³ in peripheral blood (< 1,000 vs ≥ 1,000) after randomization
- Response as assessed by bone marrow (BM) blasts after first randomization, at evaluation of prephase, and on day 15 of induction
- Toxicity and long-term toxicity as assessed by CTC v2
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): NCT00003728
|OverallOfficial:||Jacques Otten, MD||Academisch Ziekenhuis der Vrije Universiteit Brussel|