The Efficacy and Safety of Bortezomib Combined With Fludarabine and Cytarabine Treatment for Mantle Cell Lymphoma
Bortezomib Combined With Fludarabine and Cytarabine for Mantle Cell Lymphoma Patients：a Single Arm, Open-labelled, Phase 2 Study
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
Mantle cell lymphoma (MCL) is a type of non-Hodgkin's lymphoma (NHL) and shows poor survival. This study to evaluate the efficacy and safety of Bortezomib combined with Fludarabine and Cytarabine treatment in the naive and relapsed MCL who are not eligible for high dose therapy and transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2017
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedFirst Posted
Study publicly available on registry
January 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJanuary 11, 2017
August 1, 2016
1.9 years
October 11, 2016
January 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progress-free survival
Interval from registration to progression or death from any cause
Follow-up to 36 months
Secondary Outcomes (1)
Overall response rate
Up to 36 months
Study Arms (1)
Bortezomib,Fludarabine and Cytarabine
OTHERBortezomib(V) 1.3mg/m2, subcutaneously,day 1,4,8,11; Fludarabine(F) 25mg/m2, intravenously day 1-3; Cytarabine(A) 500mg/m2 for 3 days(day1-3).
Interventions
Bortezomib(V) 1.3mg/m2, subcutaneously,day 1,4,8,11;
Fludarabine(F) 25mg/m2, intravenously day 1-3;
Cytarabine(A) 500mg/m2 for 3 days(day1-3)
Eligibility Criteria
You may qualify if:
- pathologically confirmed, previously untreated MCL or relapsed MCL as defined by the World Health Organization classification;
- age≥18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- adequate haematologic function (haemoglobin \> 9.0 g/l, absolute neutrophil count \> 1500/ml, platelets \> 75,000/l),
- adequate hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal),
- adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min);
- normal coagulation function and electrocardiogram results.
- willingness to provide written informed consent.
You may not qualify if:
- MCL patients who do NOT response or are refractory to preview treatment.
- Who do NOT sign the consent form.
- whose life expectation is less than 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tingbo Liulead
- Union hospital of Fujian Medical Universitycollaborator
Related Publications (1)
Cheah CY, Seymour JF, Wang ML. Mantle Cell Lymphoma. J Clin Oncol. 2016 Apr 10;34(11):1256-69. doi: 10.1200/JCO.2015.63.5904. Epub 2016 Jan 11.
PMID: 26755518RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of medicine
Study Record Dates
First Submitted
October 11, 2016
First Posted
January 11, 2017
Study Start
January 1, 2017
Primary Completion
December 1, 2018
Study Completion
December 1, 2020
Last Updated
January 11, 2017
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share