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Rituximab Plus Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia

NCT01358253 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-05-20

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Weili Zhao, MD,PhD · Department of hematology Ruijin Hospital/Shanghai Institute of Hematology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01358253 on ClinicalTrials.gov