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

NCT00006455 | Completed Phase 3

• 4 other identifiers: CDR0000068133FRE-IGR-ALCL99EU-20031NHL2000/06
• Study Type: interventional
• Target: 885
• Locations: 10 countries
• Sites: 10

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.

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Event-free survival

Secondary Outcomes (5)

• Overall survival

• Complete remission achieved after treatment course B3 and lasting ≥ 4 weeks

• Short- and long-term toxicity

• Nonlymphoma related death and early deaths (excluding deaths occurring after second-line treatment for failure or relapse)

• CNS relapses

Interventions

cyclophosphamide DRUG

cytarabine DRUG

dexamethasone DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

ifosfamide DRUG

leucovorin calcium DRUG

methotrexate DRUG

therapeutic hydrocortisone DRUG

vinblastine sulfate DRUG

Eligibility Criteria

• Age: 0 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (10)

St. Anna Children's Hospital

Vienna, A-1090, Austria

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Kinderklinik

Giessen, D-35385, Germany

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Dutch Childhood Leukemia Study Group

The Hague, 2504 AM, Netherlands

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Karolinska University Hospital - Huddinge

Stockholm, S-171 76, Sweden

Location

University Children's Hospital

Zurich, CH-8032, Switzerland

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Related Publications (3)

• Attarbaschi A, Mann G, Rosolen A, Williams D, Uyttebroeck A, Marky I, Lamant L, Horibe K, Wrobel G, Beishuizen A, Wossmann W, Reiter A, Mauguen A, Le Deley MC, Brugieres L; European Intergroup for Childhood Non-Hodgkin Lymphoma (EICNHL) ALCL99 Trial. Limited stage I disease is not necessarily indicative of an excellent prognosis in childhood anaplastic large cell lymphoma. Blood. 2011 May 26;117(21):5616-9. doi: 10.1182/blood-2010-12-324012. Epub 2011 Mar 28.

  PMID: 21444917 RESULT

• Wrobel G, Mauguen A, Rosolen A, Reiter A, Williams D, Horibe K, Brugieres L, Le Deley MC; European Inter-Group for Childhood, Non-Hodgkin Lymphoma (EICNHL). Safety assessment of intensive induction therapy in childhood anaplastic large cell lymphoma: report of the ALCL99 randomised trial. Pediatr Blood Cancer. 2011 Jul 1;56(7):1071-7. doi: 10.1002/pbc.22940. Epub 2011 Jan 28.

  PMID: 21280197 RESULT

• Le Deley MC, Rosolen A, Williams DM, Horibe K, Wrobel G, Attarbaschi A, Zsiros J, Uyttebroeck A, Marky IM, Lamant L, Woessmann W, Pillon M, Hobson R, Mauguen A, Reiter A, Brugieres L. Vinblastine in children and adolescents with high-risk anaplastic large-cell lymphoma: results of the randomized ALCL99-vinblastine trial. J Clin Oncol. 2010 Sep 1;28(25):3987-93. doi: 10.1200/JCO.2010.28.5999. Epub 2010 Aug 2.

  PMID: 20679620 RESULT

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large-Cell, Anaplastic

Interventions

Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin; Etoposide; Ifosfamide; Leucovorin; Methotrexate; Hydrocortisone; Vinblastine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Oxazines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Aminopterin; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Laurence Brugieres, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2000
• First Posted: January 27, 2003
• Study Start: November 26, 1999
• Primary Completion: January 12, 2009
• Study Completion: September 3, 2020
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

DE (1); CH (1); SE (1); AU (1); IT (1); NL (1); GB (1); FR (1); ES (1); BE (1)