Clinical trial · Interventional
Applying Pediatric Regimens to Younger Adult Patients With Acute Lymphoblastic Leukemia (ALL)
Phase 2 Study of Applying Pediatric Regimens to Younger Adult Patients With BCR-ABL-Negative Acute Lymphoblastic Leukemia
NCT00131053CI-TRIAL-00001784unknownPhase 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)
The purpose of this study is to investigate the efficacy and safety for treating adult ALL patients with the pediatric protocol.
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 |
|---|---|---|---|
| Lymphoblastic Leukemia, Acute | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Hydrocortisone | Drug | — | UNRESOLVED |
| L-asparaginase | Drug | Asparaginase | ALIAS |
| Mercaptopurine | Drug | Mercaptopurine | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Pirarubicin | Drug | — | UNRESOLVED |
| Prednisolone |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: Methotrexate
- Drug: Prednisolone
- Drug: Dexamethasone
- Drug: Vincristine
- Drug: Pirarubicin
- Drug: Cyclophosphamide
- Drug: L-asparaginase
- Drug: Cytarabine
- Drug: Hydrocortisone
- Drug: Mercaptopurine
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 3 years
Secondary outcomes (1)
- measure
- The rate of complete remission
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 24 Years
Show eligibility criteria text
Inclusion Criteria: * Previously untreated BCR-ABL-negative ALL * Age between 15 and 24 years * Performance status between 0 and 3 (ECOG criteria) * Adequate functioning of the liver (serum bilirubin level \< 2.0 mg/dL); kidneys (serum creatinine level \< 2.0 mg/dL); and heart (left ventricular ejection fraction greater than 50% and no severe abnormalities detected on electrocardiograms and echocardiographs). * Written informed consent to participate in the trial Exclusion Criteria: * Uncontrolled active infection * Another severe and/or life-threatening disease * Positive for HIV antibody and/or hepatitis B surface (HBs) antigen tests * Another primary malignancy which is clinically active and/or requires medical interventions * Pregnant and/or lactating women * Past history of renal failure
References
Publications (0)
Data not yet available
No reference posted for this study.