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Combination of Bortezomib, Fludarabine and Cyclophosphamide Treat Recurrent Mantle Cell Lymphoma

NCT01322776 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-03-25

No results posted yet for this study

Summary

This is a multi-center, single arm, open-label, prospective IIS study, which will enroll 40 recurrent MCL patients.The aim is to evaluate the efficacy and safety of bortezomib, fludarabine and cyclophosphamide treatment and also analyze the relationship between NF-kB activity and efficacy of bortezomib treatment and whether NF-kB activity can predict MCL progression.

Conditions

  • Mantle Cell Lymphoma Recurrent

Interventions

DRUG

Combination of Bortezomib, Fludarabine and Cyclophosphamide

bortezomib 1.3mg/m\^2 i.v. on days 1, 4, 8 and 11 of each 28-day cycle fludarabine 25mg/m\^2 i.v. on days 1\~3 of each 28-day cycle cyclophosphamide i.v. on days 1\~2 of each 28-day cycle

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Zhejiang University

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Ruijin Hospital

    collaborator OTHER

  • Tianjin Medical University Cancer Institute and Hospital

    collaborator OTHER

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • Jiangsu Cancer Institute & Hospital

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • China

Study Locations

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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 NCT01322776 on ClinicalTrials.gov