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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01322776
Other study ID # Vel-FC-4003
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received March 24, 2011
Last updated March 24, 2011
Start date March 2011
Est. completion date October 2013

Study information

Verified date March 2011
Source Sun Yat-sen University
Contact Huiqiang Huang
Email huanghq@sysucc.org.cn
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
China SunYat-sen University Cancer Centre Guang Zhou Guang Dong

Sponsors (8)

Lead Sponsor Collaborator
Sun Yat-sen University Beijing Cancer Hospital, Fudan University, Jiangsu Cancer Institute & Hospital, Ruijin Hospital, Tianjin Medical University Cancer Institute and Hospital, West China Hospital, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical efficacy will be assessed according to the CT scan and bone marrow aspirate and biopsy The International Working Group (IWG) published the guidelines for response criteria for lymphoma in 1999. These response criteria are based on the reduction in the size of the enlarged lymph node as measured by CT scan and the extent of bone marrow involvement that is determined by bone marrow aspirate and biopsy. 2cycle,28-day/cycle Yes
Secondary Maximum Tolerated Dose(MTD)of Cyclophosphamide Maximum tolerated dose (MTD) of cyclophosphamide will be determined in accordance with the standard "3+3" method, testing three dose levels, 150mg/m^2, 200mg/m^2 and 250mg/m^2. Cyclophosphamide dose escalation test will be conducted in the first cycle, with every three patients in a group. Patients' enrollment will be competed among different sites, but futher step should be taken only after the 3 patients in one group complete the first cycle, their efficacy and safety have been completely evaluated, and the notification of going to next step by a CRO company. 6 months Yes
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