Rituximab Plus Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia
Recruitment status was Recruiting
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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 | Intervention | Phase |
|---|---|---|
|
Acute Lymphoblastic Leukemia |
Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Dexamethasone Drug: Cytarabine Drug: Methotrexate Drug: Rituximab Drug: 6-Mercaptopurine Drug: Prednisone Drug: L-asparaginase |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective Study of Rituximab Combined With Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia |
- CR duration [ Time Frame: After two 21-day courses ] [ Designated as safety issue: Yes ]Bone marrow MRD examination every two months
- disease free survival [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: HyperCVAD
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. |
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: 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.
|
|
Experimental: R-HyperCVAD
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. |
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. 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Weili Zhao, MD,PhD | 86-21-64370045 ext 610707 | weili_zhao_sih@yahoo.com |
| Contact: Pengpeng Xu, MD | 86-21-64370045 ext 610707 | xpproc@msn.com |
| China, Shanghai | |
| Ruijin Hospital | Recruiting |
| Shanghai, Shanghai, China, 200025 | |
| Contact: Weili Zhao, MD,PhD 86-21-64370045 ext 610707 weili_zhao_sih@yahoo.com | |
| Principal Investigator: | Weili Zhao, MD,PhD | Department of hematology Ruijin Hospital/Shanghai Institute of Hematology |
More Information
No publications provided
| Responsible Party: | Zhao Weili/Professor, Department of hematology Ruijin Hospital/Shanghai Institute of hematology |
| ClinicalTrials.gov Identifier: | NCT01358253 History of Changes |
| Other Study ID Numbers: | RJ-2010-56 |
| Study First Received: | May 18, 2011 |
| Last Updated: | May 20, 2011 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Ruijin Hospital:
|
Rituximab HyperCVAD |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases 6-Mercaptopurine Cytarabine Methotrexate Cyclophosphamide Rituximab Asparaginase |
Dexamethasone Doxorubicin Prednisone Vincristine BB 1101 Dexamethasone acetate Dexamethasone 21-phosphate Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 21, 2013