Clinical trial · Interventional
Combination Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia
EXTRAMEDULLARY RELAPSE AND OCCULT BONE MARROW INVOLVEMENT IN CHILDHOOD ACUTE LYMPHOBLASTIC LEUKEMIA: A PHASE III GROUP-WIDE STUDY
NCT00002816CI-TRIAL-00011821completedPhase 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 cancer cells from dividing so they stop growing or die. PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy in treating children who have relapsed acute lymphoblastic 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 (15)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| idarubicin | Drug | Idarubicin | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| low-LET cobalt-60 gamma ray therapy | Radiation | — | UNRESOLVED |
| low-LET electron therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EARLY # CNS RELAPSE with BM DONOR
- description
- Induction (Etoposide, Ifosfamide with Mesna Uroprotection,Ifosfamide, Dexamethasone, Vincristine sulfate, PEG, ITT (methotrexate, cytosine arabinoside and therapeutic hydrocortisone), and leucovorin calcium then Intensification (4 courses of 6 weeks, ITT, dexamethasone, vincristine, methotrexate, leucovorin, 6-Thioguanine, cytarabine (Ara-C), Etoposide, pegaspargase, Ifosfamide with Mesna) and Idarubicin and CXRT.
- interventionNames
- Drug: cytarabine
- Drug: dexamethasone
- Drug: etoposide
- Drug: idarubicin
- Drug: ifosfamide
- Drug: leucovorin calcium
- Drug: mesna
- Drug: pegaspargase
- Drug: therapeutic hydrocortisone
- Drug: thioguanine
- Drug: vincristine sulfate
- Radiation: low-LET electron therapy
- Radiation: low-LET photon therapy
- Drug: Methotrexate
- type
- EXPERIMENTAL
- label
- LATE CNS RELAPSE with/without BM DONOR, TESTICULAR or OCULAR
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 20 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Acute lymphoblastic leukemia (ALL) with isolated extramedullary relapse Relapse occurred during or following front-line therapy for ALL Initial diagnosis of more than 25% blasts of L1 or L2 morphology No leukemic marrow (M1) by conventional assessment Patients with B precursor ALL must also be enrolled on study CCG-B958 Relapse occurred in the CNS, testis, or eye Ocular relapse confirmed by an ophthalmologist and by cytology or iris biopsy Combined CNS and ocular relapse eligible Down Syndrome patients not eligible No prior bone marrow transplantation in first remission No prior toxicity from any study drugs Patient age: Under 21 PATIENT CHARACTERISTICS: See General Eligibility Criteria
References
Publications (2)
- RESULTUckun FM, Gaynon PS, Stram DO, Sensel MG, Sarquis MB, Willoughby M. Bone marrow leukemic progenitor cell content in pediatric T-lineage acute lymphoblastic leukemia patients with an isolated extramedullary first relapse. Leuk Lymphoma. 2001 Jan;40(3-4):279-85. doi: 10.3109/10428190109057926. PMID 11426549
- RESULTUckun FM, Gaynon PS, Stram DO, Sensel MG, Sarquis MB, Lazarus KH, Willoughby M. Paucity of leukemic progenitor cells in the bone marrow of pediatric B-lineage acute lymphoblastic leukemia patients with an isolated extramedullary first relapse. Clin Cancer Res. 1999 Sep;5(9):2415-20. PMID 10499612