Combination Chemotherapy Plus Steroid Therapy in Treating Children With Acute Lymphoblastic Leukemia or Lymphoblastic Non-Hodgkin's Lymphoma
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: methylprednisolone Drug: mitoxantrone hydrochloride Drug: prednisolone Drug: therapeutic hydrocortisone Drug: thioguanine Drug: vincristine sulfate Drug: vindesine Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | 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 |
- Event-free survival after first randomization [ Designated as safety issue: No ]
- Disease-free survival after second and third randomization [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Response to prephase as assessed by number of blasts/mm³ in peripheral blood (< 1,000 vs ≥ 1,000) after randomization [ Designated as safety issue: No ]
- Response as assessed by bone marrow (BM) blasts after first randomization, at evaluation of prephase, and on day 15 of induction [ Designated as safety issue: No ]
- Toxicity and long-term toxicity as assessed by CTC v2 [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1500 |
| Study Start Date: | December 1998 |
| Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 therapy
Contacts and Locations| Belgium | |
| Ziekenhuis Netwerk Antwerpen Middelheim | |
| Antwerp, Belgium, 2020 | |
| Academisch Ziekenhuis der Vrije Universiteit Brussel | |
| Brussels, Belgium, 1090 | |
| Hopital Universitaire Des Enfants Reine Fabiola | |
| Brussels, Belgium, 1020 | |
| Ghent University | |
| Ghent, Belgium, B-9000 | |
| Universitair Ziekenhuis Gent | |
| Ghent, Belgium, B-9000 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Centre Hospitalier Regional de la Citadelle | |
| Liege, Belgium, 4000 | |
| Clinique de l'Esperance | |
| Montegnee, Belgium, 4420 | |
| France | |
| Centre Hospitalier Regional et Universitaire d'Angers | |
| Angers, France, 49033 | |
| CHR de Besancon - Hopital Saint-Jacques | |
| Besancon, France, 25030 | |
| CHU de Caen | |
| Caen, France, 14033 | |
| CHU de Grenoble - Hopital de la Tronche | |
| Grenoble, France, 38043 | |
| Hopital Debrousse | |
| Lyon, France, 69322 | |
| Hopital Arnaud de Villeneuve | |
| Montpellier, France, 34059 | |
| CHR Hotel Dieu | |
| Nantes, France, 44035 | |
| Hopital de l'Archet CHU de Nice | |
| Nice, France, F-06202 | |
| CHU - Hopital Robert Debre | |
| Paris, France, 75019 | |
| Hopital Jean Bernard | |
| Poitiers, France, 86021 | |
| Hopital Americain | |
| Reims, France, 51092 | |
| Hopital Universitaire Hautepierre | |
| Strasbourg, France, 67098 | |
| Hopital des Enfants | |
| Toulouse, France, 31026 | |
| Portugal | |
| Instituto Portugues de Oncologia Centro do Porto, SA | |
| Porto, Portugal, 4200 | |
| Hospital Escolar San Joao | |
| Porto, Portugal, 4200 | |
| Investigator: | Jacques Otten, MD | Academisch Ziekenhuis der Vrije Universiteit Brussel |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00003728 History of Changes |
| Other Study ID Numbers: | CDR0000066840, EORTC-58951 |
| Study First Received: | November 1, 1999 |
| Last Updated: | January 20, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I childhood lymphoblastic lymphoma stage II childhood lymphoblastic lymphoma stage III childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma untreated childhood acute lymphoblastic leukemia |
L1 childhood acute lymphoblastic leukemia L2 childhood acute lymphoblastic leukemia T-cell childhood acute lymphoblastic leukemia B-cell childhood acute lymphoblastic leukemia acute undifferentiated leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases 6-Mercaptopurine Cytarabine Methotrexate Thioguanine |
Cyclophosphamide Asparaginase Daunorubicin Dexamethasone Doxorubicin Etoposide Methylprednisolone Hemisuccinate Prednisolone Mitoxantrone Vincristine Vindesine BB 1101 Dexamethasone acetate Cortisol succinate Hydrocortisone acetate |
ClinicalTrials.gov processed this record on June 18, 2013