Clinical trial · Interventional
Induction Intensification in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia
Induction Intensification in Infant ALL: A Children's Oncology Group Study
NCT00002756CI-TRIAL-00013777completedPhase 2ClinicalTrials.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 work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them as induction intensification may kill more cancer cells. PURPOSE: This phase II trial is studying how well induction intensification works in treating infants with newly diagnosed acute lymphocytic leukemia.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| asparaginase | Drug | Asparaginase | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| mercaptopurine | Drug | Mercaptopurine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemo (Reduced Induction) No BMT (Open February 2004)
- interventionNames
- Biological: filgrastim
- Drug: asparaginase
- Drug: cyclophosphamide
- Drug: cytarabine
- Drug: daunorubicin hydrochloride
- Drug: etoposide
- Drug: leucovorin calcium
- Drug: mercaptopurine
- Drug: methotrexate
- Drug: prednisone
- Drug: therapeutic hydrocortisone
- Drug: vincristine sulfate
Primary outcomes (3)
- measure
- Feasibility of intensification
- measure
- Event-free survival
- measure
- Comparison of event-free survival rates in infants with and without leukemic blasts translocations
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 1 Year
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia * No infants less than 36 weeks' gestation * CNS or testicular disease permitted * No B-cell ALL or acute myeloid leukemia * Previously untreated except for the following: * Steroid treatment within 48 hours of diagnosis allowed with physical examination and differential CBC immediately prior to beginning steroids * Concurrent registration on protocol POG-9900 (ALL classification study) required * Patients registered on POG-9407 are eligible for the pharmacokinetic part of the study PATIENT CHARACTERISTICS: Age: * Under 1 at diagnosis Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No uncontrolled infection * Adequate major organ function PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * See Disease Characteristics * No concurrent chronic steroid treatment Radiotherapy: * Not specified Surgery: * Not specified Other: * No other concurrent anticancer therapy
References
Publications (6)
- BACKGROUNDDreyer ZE, Dinndorf PA, Camitta B, Sather H, La MK, Devidas M, Hilden JM, Heerema NA, Sanders JE, McGlennen R, Willman CL, Carroll AJ, Behm F, Smith FO, Woods WG, Godder K, Reaman GH. Analysis of the role of hematopoietic stem-cell transplantation in infants with acute lymphoblastic leukemia in first remission and MLL gene rearrangements: a report from the Children's Oncology Group. J Clin Oncol. 2011 Jan 10;29(2):214-22. doi: 10.1200/JCO.2009.26.8938. Epub 2010 Dec 6. PMID 21135279
- BACKGROUNDFernandez CV, Kodish E, Taweel S, Shurin S, Weijer C; Children's Oncology Group. Disclosure of the right of research participants to receive research results: an analysis of consent forms in the Children's Oncology Group. Cancer. 2003 Jun 1;97(11):2904-9. doi: 10.1002/cncr.11391. PMID 12767106
- RESULTKang H, Wilson CS, Harvey RC, Chen IM, Murphy MH, Atlas SR, Bedrick EJ, Devidas M, Carroll AJ, Robinson BW, Stam RW, Valsecchi MG, Pieters R, Heerema NA, Hilden JM, Felix CA, Reaman GH, Camitta B, Winick N, Carroll WL, Dreyer ZE, Hunger SP, Willman CL. Gene expression profiles predictive of outcome and age in infant acute lymphoblastic leukemia: a Children's Oncology Group study. Blood. 2012 Feb 23;119(8):1872-81. doi: 10.1182/blood-2011-10-382861. Epub 2011 Dec 30. PMID 22210879
- RESULTSalzer WL, Jones TL, Devidas M, Hilden JM, Winick N, Hunger S, Carroll WL, Camitta B, Dreyer ZE. Modifications to induction therapy decrease risk of early death in infants with acute lymphoblastic leukemia treated on Children's Oncology Group P9407. Pediatr Blood Cancer. 2012 Nov;59(5):834-9. doi: 10.1002/pbc.24132. Epub 2012 Apr 5. PMID 22488662
- RESULTRobinson BW, Devidas M, Carroll AJ, et al.: Specific MLL partner genes in infant acute lymphoblastic leukemia (ALL) associated with outcome are linked to age and white blood cell count (WBC) at diagnosis: A report on the Children's Oncology Group (COG) P9407 trial. [Abstract] Blood 114 (22): A-907, 2009.
- RESULTThompson PA, Murry DJ, Rosner GL, Lunagomez S, Blaney SM, Berg SL, Camitta BM, Dreyer ZE, Bomgaars LR. Methotrexate pharmacokinetics in infants with acute lymphoblastic leukemia. Cancer Chemother Pharmacol. 2007 May;59(6):847-53. doi: 10.1007/s00280-006-0388-1. Epub 2006 Nov 29.