Clinical trial · Interventional
Combination Chemotherapy Plus Steroid Therapy in Treating Children With Acute Lymphoblastic Leukemia or Lymphoblastic Non-Hodgkin's Lymphoma
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
- 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 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (19)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| asparaginase | Drug | Asparaginase | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Event-free survival after first randomization
- measure
- Disease-free survival after second and third randomization
Secondary outcomes (4)
- measure
- Overall survival
- measure
- Response to prephase as assessed by number of blasts/mm³ in peripheral blood (< 1,000 vs ≥ 1,000) after randomization
- measure
- Response as assessed by bone marrow (BM) blasts after first randomization, at evaluation of prephase, and on day 15 of induction
- measure
- Toxicity and long-term toxicity as assessed by CTC v2
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 17 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed acute lymphoblastic leukemia (ALL) of FAB L1 or L2 morphology
* Positive SIg allowed OR
* Histologically confirmed precursor B or precursor T lymphoblastic non-Hodgkin's lymphoma (NHL)
* No diffuse large cell B-cell lymphoma, Burkitt's lymphoma, or high-grade B-cell lymphoma (Burkitt-like)
* Very low-risk (VLR) patients meeting 1 of the following criteria:
* ALL of B-cell lineage
* WBC less than 10,000/mm\^3
* Must meet 1 of the following conditions:
* DNA index greater than 1.16 and less than 1.50 and chromosome number 51-66 or unknown
* DNA index not assessed and chromosome number 51-66
* DNA index greater than 1.16 and less than 1.50 and chromosome number is unknown
* Good response to prephase therapy
* Absence of t(9;22) or BCR/ABL, t(4;11)/MLL-AF4, or 11q23/MLL rearrangement
* No acute undifferentiated leukemia (AUL)
* No CNS or gonadal involvement
* Precursor B-lymphoblastic NHL stage I or II OR
* Average risk (AR) patients:
* Must meet 1 of the following criteria:
* ALL with good response to prephase therapy who are neither VLR or very high risk (VHR)
* VLR ALL with CNS involvement (CSF positive or negative)
* Precursor B-lymphoblastic NHL stage III or IV without any VHR feature
* Precursor T-lymphoblastic NHL
* AR patients substratified in:
* AR1: B-cell lineage ALL with WBC less than 100,000/mm\^3
* Surreptitious or hemorrhagic CSF becoming negative at D4 of prephase therapy
* Precursor B-lymphoblastic NHL stage III or IV
* Precursor T-lymphoblastic NHL stage I or II
* AR2: B-cell lineage ALL with WBC at least 100,000/mm\^3
* T-cell lineage ALL regardless of the WBC
* Overt or non-equivocal CNS involvement at D0 or any CSF involvement at D4
* Gonadal involvement
* Precursor T-lymphoblastic NHL stage III or IV
* Newborn Down syndrome patients with AR2 features are assigned to the AR1 group OR
* VHR patients:
* Must meet 1 of the following criteria:
* ALL patients meeting 1 of the following conditions:
* Poor response to prephase therapy (at least 1,000/mm\^3 blasts in peripheral blood after completion of prephase therapy)
* t(9;22) or BCR/ABL
* t(4;11)/MLL-AF4 = 11q23/MLL rearrangement
* Near haploidy (no more than 34 chromosomes or DNA index less than 0.7)
* Hypodiploid (35-40 chromosomes or DNA index 0.7 to 0.8)
* AUL
* For B lineage ALL: failure to achieve complete response (CR) after completion of protocol IA
* For T lineage ALL: failure to achieve CR or good partial response (GPR) after completion of protocol IA
* Minimal-residual disease (greater than 1,000 blasts/100,000 mononuclear bone marrow cells) at evaluation of IA (day 35)
* NHL patients who failed to achieve CR or GPR after completion of protocol IA
* All VHR patients are eligible for stem cell transplantation except those whose sole VHR criterion is a poor response to prephase therapy and who have none of the following features:
* T-cell immunophenotype
* Early B ALL (CD10 negative)
* WBC at least 100,000/mm\^3
* Newborn Down syndrome patients with VHR features are assigned to AR1 group NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
* Under 18
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Not specified
Renal:
* Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No prior therapyReferences
Publications (17)
- BACKGROUNDDucassou S, Ferlay C, Bergeron C, Girard S, Laureys G, Pacquement H, Plantaz D, Lutz P, Vannier JP, Uyttebroeck A, Bertrand Y. Clinical presentation, evolution, and prognosis of precursor B-cell lymphoblastic lymphoma in trials LMT96, EORTC 58881, and EORTC 58951. Br J Haematol. 2011 Feb;152(4):441-51. doi: 10.1111/j.1365-2141.2010.08541.x. Epub 2011 Jan 7. PMID 21210776
- BACKGROUNDClappier E, Collette S, Grardel N, Girard S, Suarez L, Brunie G, Kaltenbach S, Yakouben K, Mazingue F, Robert A, Boutard P, Plantaz D, Rohrlich P, van Vlierberghe P, Preudhomme C, Otten J, Speleman F, Dastugue N, Suciu S, Benoit Y, Bertrand Y, Cave H; EORTC-CLG. NOTCH1 and FBXW7 mutations have a favorable impact on early response to treatment, but not on outcome, in children with T-cell acute lymphoblastic leukemia (T-ALL) treated on EORTC trials 58881 and 58951. Leukemia. 2010 Dec;24(12):2023-31. doi: 10.1038/leu.2010.205. Epub 2010 Sep 23. PMID 20861920
- BACKGROUNDClappier E, Collette S, Grardel N, et al.: Prognostic significance of NOTCH1 and FBXW7 mutations in childhood T-cell acute lymphoblastic leukemia (T-ALL): results from the EORTC Children Leukemia Group. [Abstract] Blood 114 (22): A-909, 2009.
- BACKGROUNDRenneville A, Kaltenbach S, Clappier E, Collette S, Micol JB, Nelken B, Lepelley P, Dastugue N, Benoit Y, Bertrand Y, Preudhomme C, Cave H. Wilms tumor 1 (WT1) gene mutations in pediatric T-cell malignancies. Leukemia. 2010 Feb;24(2):476-80. doi: 10.1038/leu.2009.221. Epub 2009 Oct 22. No abstract available. PMID 19847202
- BACKGROUNDCave H, Suciu S, Preudhomme C, Poppe B, Robert A, Uyttebroeck A, Malet M, Boutard P, Benoit Y, Mauvieux L, Lutz P, Mechinaud F, Grardel N, Mazingue F, Dupont M, Margueritte G, Pages MP, Bertrand Y, Plouvier E, Brunie G, Bastard C, Plantaz D, Vande Velde I, Hagemeijer A, Speleman F, Lessard M, Otten J, Vilmer E, Dastugue N; EORTC-CLG. Clinical significance of HOX11L2 expression linked to t(5;14)(q35;q32), of HOX11 expression, and of SIL-TAL fusion in childhood T-cell malignancies: results of EORTC studies 58881 and 58951. Blood. 2004 Jan 15;103(2):442-50. doi: 10.1182/blood-2003-05-1495. Epub 2003 Sep 22.