Clinical trial · Interventional
Combination Chemotherapy in Treating Children With Anaplastic Large Cell Lymphoma (ALCL 99)
International Protocol for the Treatment of Childhood Anaplastic Large Cell Lymphoma
NCT00006455CI-TRIAL-00058807ALCL 99completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Event-free survival
Secondary outcomes (5)
- measure
- Overall survival
- measure
- Complete remission achieved after treatment course B3 and lasting ≥ 4 weeks
- measure
- Short- and long-term toxicity
- measure
- Nonlymphoma related death and early deaths (excluding deaths occurring after second-line treatment for failure or relapse)
- measure
- CNS relapses
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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 lymphomaReferences
Publications (3)
- RESULTAttarbaschi 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
- RESULTWrobel 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
- RESULTLe 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