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Combination Chemotherapy in Treating Children With Anaplastic Large Cell Lymphoma (ALCL 99) (ALCL 99)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00006455
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 31, 2022
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lymphoma Drug: cyclophosphamide Drug: cytarabine Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: leucovorin calcium Drug: methotrexate Drug: therapeutic hydrocortisone Drug: vinblastine sulfate Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 885 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: International Protocol for the Treatment of Childhood Anaplastic Large Cell Lymphoma
Actual Study Start Date : November 26, 1999
Actual Primary Completion Date : January 12, 2009
Actual Study Completion Date : September 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Event-free survival

Secondary Outcome Measures :
  1. Overall survival
  2. Complete remission achieved after treatment course B3 and lasting ≥ 4 weeks
  3. Short- and long-term toxicity
  4. Nonlymphoma related death and early deaths (excluding deaths occurring after second-line treatment for failure or relapse)
  5. CNS relapses

Eligibility Criteria
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Ages Eligible for Study:   0 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven standard-risk (SR) or high-risk (HR) anaplastic large cell lymphoma

    • SR disease defined by no involvement of the skin, mediastinum, liver, spleen, or lung

    • HR disease defined by any of the following:

      • Biopsy proven skin lesions (except skin lesions overlying an involved node or isolated skin disease)
      • Mediastinal involvement by x-ray or CT scan
      • Involvement of the liver (enlarged by at least 5 cm and/or nodular), spleen (enlarged and/or nodular), or lung (biopsy not needed for obvious lesions)
  • Histologic or cytologic slides must be available for national pathology review for all patients not meeting the classical criteria for diagnosis (typical histopathology, immunohistochemistry: CD30 positive, endomysial antibody positive, nucleophosmin negative, anaplastic lymphoma kinase (ALK) positive (if available), null or T-immunophenotype) unless proven t(2;5)
  • Must enroll within 1 week prior to beginning study regimen A
  • No CNS involvement (CSF or cerebral tumor)

  • First randomization (SR or HR disease):

    • Must have begun prephase therapy
    • No isolated primary skin disease
    • No low-risk disease defined as completely resected stage I disease

  • Second randomization (HR disease only):

    • Must have completed first randomization therapy without disease progression

PATIENT CHARACTERISTICS:

Age:

  • Under 22

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • See Disease Characteristics

Renal:

  • Not specified

Pulmonary:

  • See Disease Characteristics

Immunologic:

  • No congenital immunodeficiency
  • No AIDS

Other:

  • No prior malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Prior corticosteroids for anaplastic large cell lymphoma allowed if given for no more than 8 days

Radiotherapy:

  • Not specified

Surgery:

  • No prior organ transplantation

Other:

  • No other prior therapy for anaplastic large cell lymphoma
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00006455


Locations
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Austria
St. Anna Children's Hospital
Vienna, Austria, A-1090
Belgium
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
France
Institut Gustave Roussy
Villejuif, France, F-94805
Germany
Kinderklinik
Giessen, Germany, D-35385
Italy
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Netherlands
Dutch Childhood Leukemia Study Group
Den Haag, Netherlands, 2504 AM
Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Sweden
Karolinska University Hospital - Huddinge
Stockholm, Sweden, S-171 76
Switzerland
University Children's Hospital
Zurich, Switzerland, CH-8032
United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
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Study Chair: Laurence Brugieres, MD Gustave Roussy, Cancer Campus, Grand Paris
More Information
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Publications of Results:

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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT00006455    
Other Study ID Numbers: CDR0000068133
FRE-IGR-ALCL99
EU-20031
NHL2000/06
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 31, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
stage I childhood anaplastic large cell lymphoma
stage II childhood anaplastic large cell lymphoma
stage III childhood anaplastic large cell lymphoma
stage IV childhood anaplastic large cell lymphoma
recurrent childhood anaplastic large cell lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Leucovorin
Cytarabine
Dexamethasone
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
 Hydrocortisone acetate
Hydrocortisone hemisuccinate
Cyclophosphamide
Ifosfamide
Doxorubicin
Liposomal doxorubicin
Methotrexate
Etoposide
Vinblastine
Levoleucovorin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating