Clinical trial · Interventional
Rituximab Plus Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia
Prospective Study of Rituximab Combined With Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia
NCT01358253CI-TRIAL-00014590completedPhase 4ClinicalTrials.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 main purpose of this study is to evaluate the safety and efficacy of Rituximab combined with chemotherapy in CD20+ adult 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 |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 6-Mercaptopurine | Drug | Mercaptopurine | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| L-asparaginase | Drug | Asparaginase | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- HyperCVAD
- description
- Consolidation: HyperCVAD(odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Maintenance: 6-Mercaptopurine+Methotrexate for 24 months. Vincristine+Prednisone for the first 12 months. L-asparaginase in month 3 and 9.
- interventionNames
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Dexamethasone
- Drug: Cytarabine
- Drug: Methotrexate
- Drug: 6-Mercaptopurine
- Drug: Prednisone
- Drug: L-asparaginase
- type
- EXPERIMENTAL
- label
- R-HyperCVAD
- description
- Consolidation: R-HyperCVAD(odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Maintenance: 6-Mercaptopurine+Methotrexate for 24 months. Vincristine+Prednisone for the first 12 months. L-asparaginase in month 3 and 9. Rituximab in month 6 and 12.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of CD20-positive ALL * Adequate liver function (bilirubin less than or equal to 1.5\*ULN, unless considered due to tumor), and renal function (creatinine less than or equal to 1.5\*ULN, unless considered due to tumor) * Signed informed consent Exclusion Criteria: * Prior history of treatment with high-dose Ara-C, MTX or rituximab * Pregnant or lactating women * History of allergy to rituximab * Unable to sign informed consent * Active replication of HBV * History of stem cell transplantation
References
Publications (0)
Data not yet available
No reference posted for this study.