Rituximab Plus Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia

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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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

CR duration


Condition

Acute Lymphoblastic Leukemia

Intervention

Cyclophosphamide

Study Arms / Comparison Groups

 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

December 2010

Completion Date

December 2012

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

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Weili Zhao, MD,PhD, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT01358253

Organization ID

RJ-2010-56



Study Sponsor

Ruijin Hospital


Study Sponsor

Weili Zhao, MD,PhD, Principal Investigator, Department of hematology Ruijin Hospital/Shanghai Institute of Hematology


Verification Date

May 2011