Rituximab Plus Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia
Overview[ - collapse ][ - ]
| Purpose | The main purpose of this study is to evaluate the safety and efficacy of Rituximab combined with chemotherapy in CD20+ adult acute lymphoblastic leukemia. |
|---|---|
| Condition | Acute Lymphoblastic Leukemia |
| Intervention | Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Dexamethasone Drug: Cytarabine Drug: Methotrexate Drug: Rituximab Drug: 6-Mercaptopurine Drug: Prednisone Drug: L-asparaginase |
| Phase | Phase 4 |
| Sponsor | Ruijin Hospital |
| Responsible Party | Ruijin Hospital |
| ClinicalTrials.gov Identifier | NCT01358253 |
| First Received | May 18, 2011 |
| Last Updated | May 20, 2011 |
| Last verified | May 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 18, 2011 |
|---|---|
| Last Updated Date | May 20, 2011 |
| Start Date | December 2010 |
| Estimated Primary Completion Date | December 2012 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Rituximab Plus Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia |
|---|---|
| Official Title | Prospective Study of Rituximab Combined With Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia |
| Brief Summary | The main purpose of this study is to evaluate the safety and efficacy of Rituximab combined with chemotherapy in CD20+ adult acute lymphoblastic leukemia. |
| Detailed Description | Acute lymphoblastic leukemia (ALL) is a group of biologically heterogeneous diseases with diverse prognosis. Novel strategies for adult ALL have approached a CR rate of over 80%, which is similar to pediatric ALL. But the long term survival of adult ALL is only 30%-40%, much lower than pediatric patients. In our trial, all the patients will first receive Vincristine 1.4mg/m2, max 2mg IV days 1,8,15,22, Daunorubicin 45mg/m2 IV days 1-3,Cyclophosphamide 750mg/m2 IV day 1 and prednisone 40-60mg/m2,by mouth days 1-14 (VDCP)regimen as initial induction therapy. If patients achieve complete remission after induction, they will be enrolled in our study for further consolidation and maintenance. If the tumor cells in bone marrow remain 5% to 20% after induction, the patients will receive VDCLP(VDCP+L-asparaginase 6000IU/m2 IV days5,7,9,11,13) and be enrolled until complete remission. Rituximab is the main experimental intervention in our study.The consolidation regimen is HyperCVAD/MA or R-HyperCVAD/MA for totally 8 courses. The maintenance regimen includes 6-Mercaptopurine+Methotrexate for 24 months, Vincristine+Prednisone for the first 12 months, L-asparaginase in month 3 and 9 with or without Rituximab in month 6 and 12. |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Acute Lymphoblastic Leukemia |
| Intervention | Drug: Cyclophosphamide 300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2)(odd courses). Drug: Doxorubicin 50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses). Drug: Vincristine Consolidation:1.4 mg/m2 (max 2mg) IV on day 4 and day 11 (odd courses). Maintenance:1.4mg/m2(max 2mg) IV monthly from 1st to 12th month. Drug: Dexamethasone 40mg IV or by mouth (P.O.) daily days 1-4 and days 11-14(odd courses) Drug: Cytarabine 2g/m2 IV over 2 hours every 12 hours for 4 doses on days 2, 3 (even courses). Drug: Methotrexate Consolidation:1000 mg/m2 IV over 24 hours on day 1 (even courses). Maintenance:25mg/m2 weekly for 24 months. Drug: Rituximab Consolidation:375 mg/m2 IV day 1 for the odd courses of therapy (total 4 times). Maintenance:375 mg/m2 IV in 6th month and 12th month. Drug: 6-Mercaptopurine Maintenance:60mg/m2 daily for 24 months. Drug: Prednisone Maintenance:40mg/m2 from days 1-7 monthly from 1st to 12th month. Drug: L-asparaginase Maintenance:6000IU/m2 IV on days 1,3,5 of the 3rd and 9th month. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 100 |
| Estimated Completion Date | December 2012 |
| Estimated Primary Completion Date | December 2012 |
| Eligibility Criteria | 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Weili Zhao, MD,PhD 86-21-64370045 weili_zhao_sih@yahoo.com |
| Location Countries | China |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01358253 |
|---|---|
| Other Study ID Numbers | RJ-2010-56 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Ruijin Hospital |
| Study Sponsor | Ruijin Hospital |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Weili Zhao, MD,PhD Department of hematology Ruijin Hospital/Shanghai Institute of Hematology |
| Verification Date | May 2011 |
Locations[ + expand ][ + ]
| Ruijin Hospital | Shanghai, Shanghai, China, 200025 Contact: Weili Zhao, MD,PhD | 86-21-64370045610707 | weili_zhao_sih@yahoo.comRecruiting |
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