Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Rituximab Plus Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
Information provided by:
Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT01358253
First received: May 18, 2011
Last updated: May 19, 2014
Last verified: May 2011
  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

Resource links provided by NLM:


Further study details as provided by Ruijin Hospital:

Primary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: December 2010
Study Completion Date: December 2012
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.

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.

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358253

Locations
China, Shanghai
Ruijin Hospital
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Ruijin Hospital
Investigators
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 19, 2014
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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
6-Mercaptopurine
Asparaginase
Cyclophosphamide
Cytarabine
Dexamethasone
Methotrexate
Prednisone
Rituximab
Vincristine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on November 27, 2014