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The Efficacy and Safety of Bortezomib Combined With Fludarabine and Cytarabine Treatment for Mantle Cell Lymphoma

Primary Purpose

Mantle Cell Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Bortezomib

Fludarabine

Cytarabine

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma focused on measuring Mantle cell lymphoma, Bortezomib, Fludarabine, Cytarabine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Bortezomib,Fludarabine and Cytarabine

Arm Description

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).

Outcomes

Primary Outcome Measures

Progress-free survival

Interval from registration to progression or death from any cause

Secondary Outcome Measures

Overall response rate

Lugano classification

Full Information

NCT ID

NCT03016988

First Posted

October 11, 2016

Last Updated

January 9, 2017

Sponsor

Tingbo Liu

Collaborators

Union hospital of Fujian Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03016988

Brief Title

The Efficacy and Safety of Bortezomib Combined With Fludarabine and Cytarabine Treatment for Mantle Cell Lymphoma

Official Title

Bortezomib Combined With Fludarabine and Cytarabine for Mantle Cell Lymphoma Patients：a Single Arm, Open-labelled, Phase 2 Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2017 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Tingbo Liu

Collaborators

Union hospital of Fujian Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The eligibility criteria were 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), 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), renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min); normal coagulation function and electrocardiogram results. Stage was defined according to the Ann Arbor system. The Fujian Medical University Union Hospital approved this study before subjects were enrolled. Treatment dosages were as follows: days 1,4,8,and 11 subcutaneous infusion of 1.3mg/m2 Bortezomib. Days 1-3 intravenous infusion 25mg/m2 Fludarabine. Days 1-3 intravenous infusion of 500mg/m2 Cytarabine. The regimen was repeated every 28 days for a maximum of six cycles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mantle Cell Lymphoma

Keywords

Mantle cell lymphoma, Bortezomib, Fludarabine, Cytarabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bortezomib,Fludarabine and Cytarabine

Arm Type

Other

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

Bortezomib

Other Intervention Name(s)

Bortezomib (PS-341)

Intervention Description

Bortezomib(V) 1.3mg/m2, subcutaneously,day 1,4,8,11;

Intervention Type

Drug

Intervention Name(s)

Fludarabine

Other Intervention Name(s)

NSC 118218

Intervention Description

Fludarabine(F) 25mg/m2, intravenously day 1-3;

Intervention Type

Drug

Intervention Name(s)

Cytarabine

Other Intervention Name(s)

Cytosar-U, Cytosine Arabinoside

Intervention Description

Cytarabine(A) 500mg/m2 for 3 days(day1-3)

Primary Outcome Measure Information:

Title

Progress-free survival

Description

Interval from registration to progression or death from any cause

Time Frame

Follow-up to 36 months

Secondary Outcome Measure Information:

Title

Overall response rate

Description

Lugano classification

Time Frame

Up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Inclusion Criteria: 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. Exclusion Criteria: 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.

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

26755518

Citation

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.

Results Reference

result

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The Efficacy and Safety of Bortezomib Combined With Fludarabine and Cytarabine Treatment for Mantle Cell Lymphoma

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