Clinical trial · Interventional
Combination Chemotherapy With or Without Donor Bone Marrow Transplantation in Treating Infants With Previously Untreated Acute Lymphoblastic Leukemia
A Study of Modified Augmented BFM Therapy for Infants With Acute Lymphoblastic Leukemia
- 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. Giving the drugs in different combinations may kill more cancer cells. Bone marrow transplantation allows the doctor to give higher doses of chemotherapy and kill more cancer cells. PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or without donor bone marrow transplantation in treating infants who have previously untreated 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 |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| asparaginase | Drug | Asparaginase | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| cytarabine | Drug | Cytarabine | ALIAS |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Modified Augmented BFM Therapy
- interventionNames
- Drug: asparaginase
- Drug: cyclophosphamide
- Drug: cyclosporine
- Drug: cytarabine
- Drug: daunorubicin hydrochloride
- Drug: dexamethasone
- Drug: doxorubicin hydrochloride
- Drug: mercaptopurine
- Drug: methotrexate
- Drug: methylprednisolone
- Drug: pegaspargase
- Drug: thioguanine
- Drug: vincristine sulfate
- Procedure: allogeneic bone marrow transplantation
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Establish whether the CCG Augmented Regimen (AR) can be successfully administered in the infant age group
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 1 Year
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of previously untreated acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia * CNS or testicular disease allowed * No L3 sIg+ ALL or acute myelogenous leukemia * At least 36 weeks gestation for congenital ALL PATIENT CHARACTERISTICS: Age: * Under 366 days at diagnosis Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Steroid therapy within 48 hours of study allowed if complete blood counts and lumbar puncture results known * No chronic steroid treatment for other disease Radiotherapy: * Not specified Surgery: * Not specified Other: * No other concurrent cytotoxic therapy
References
Publications (0)
Data not yet available