Combination Chemotherapy in Treating Children With Anaplastic Large Cell Lymphoma (ALCL 99) (ALCL 99)
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ClinicalTrials.gov Identifier: NCT00006455 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : May 31, 2022
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Tracking Information | |||||
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First Submitted Date ICMJE | November 6, 2000 | ||||
First Posted Date ICMJE | January 27, 2003 | ||||
Last Update Posted Date | May 31, 2022 | ||||
Actual Study Start Date ICMJE | November 26, 1999 | ||||
Actual Primary Completion Date | January 12, 2009 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Event-free survival | ||||
Original Primary Outcome Measures ICMJE | Not Provided | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Combination Chemotherapy in Treating Children With Anaplastic Large Cell Lymphoma (ALCL 99) | ||||
Official Title ICMJE | International Protocol for the Treatment of Childhood Anaplastic Large Cell Lymphoma | ||||
Brief Summary | 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 combination chemotherapy regimen is more effective for treating anaplastic large cell lymphoma. PURPOSE: This randomized phase III trial is studying several different regimens of combination chemotherapy to compare how well they work in treating children with anaplastic large cell lymphoma. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to country, vinblastine (VBL) (yes vs no), and prognostic factors (standard-risk (SR) vs high-risk (HR) disease). Beginning immediately after confirmation of diagnosis, patients receive prephase therapy comprising dexamethasone (DM) IV or orally daily on days 1 and 2 and every 12 hours on days 3-5; cyclophosphamide (CTX) IV over 1 hour on days 1 and 2; and methotrexate (MTX) intrathecally (IT), doxorubicin (DOX) IV, and hydrocortisone (HC) IT on day 1. Patients are then assigned to one of two treatment groups based on prognosis:
Patients are followed every 2 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter. DEFINITIONS:
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study within 5.4-6.7 years. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Primary Purpose: Treatment |
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Condition ICMJE | Lymphoma | ||||
Intervention ICMJE |
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Study Arms ICMJE | Not Provided | ||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
885 | ||||
Original Enrollment ICMJE | Not Provided | ||||
Actual Study Completion Date ICMJE | September 3, 2020 | ||||
Actual Primary Completion Date | January 12, 2009 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Immunologic:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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Sex/Gender ICMJE |
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Ages ICMJE | 0 Years to 21 Years (Child, Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00006455 | ||||
Other Study ID Numbers ICMJE | CDR0000068133 FRE-IGR-ALCL99 EU-20031 NHL2000/06 |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Gustave Roussy, Cancer Campus, Grand Paris | ||||
Original Responsible Party | Not Provided | ||||
Current Study Sponsor ICMJE | Gustave Roussy, Cancer Campus, Grand Paris | ||||
Original Study Sponsor ICMJE | Societe Francaise Oncologie Pediatrique | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Gustave Roussy, Cancer Campus, Grand Paris | ||||
Verification Date | May 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |