Clinical trial · Interventional
High-Dose Methotrexate (MTX) for Adult Acute Lymphoblastic Leukemia (ALL)
Randomized Controlled Trial to Test Efficacy of High-Dose Methotrexate Consolidation Therapy for BCR-ABL-Negative Acute Lymphoblastic Leukemia in Adults
NCT00131027CI-TRIAL-00001782unknownPhase 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)
The purpose of this study is to investigate the clinical efficacy of high-dose methotrexate consolidation therapy for adult patients with BCR-ABL-negative ALL.
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 (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Daunorubicin | Drug | Daunorubicin | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| L-asparaginase | Drug | Asparaginase | ALIAS |
| Mercaptopurine | Drug | Mercaptopurine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- HD-MTX
- interventionNames
- Drug: Cyclophosphamide
- Drug: Daunorubicin
- Drug: Vincristine
- Drug: Prednisolone
- Drug: L-asparaginase
- Drug: Cytarabine
- Drug: Etoposide
- Drug: Dexamethasone
- Drug: Methotrexate
- Drug: Mercaptopurine
- Drug: Doxorubicin
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- ID-MTX
- interventionNames
- Drug: Cyclophosphamide
- Drug: Daunorubicin
- Drug: Vincristine
- Drug: Prednisolone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Previously untreated BCR-ABL-negative ALL * Age between 25 and 64 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.