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A Study of Bortezomib Plus GDP in the Treatment of Refractory and Relapsed Non-GCB DLBCL

Primary Purpose

Diffuse Large B-cell Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Bortezomib

Gemcitabine

Dexamethasone

Cisplatin

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring diffuse large b-cell lymphoma

Eligibility Criteria

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

Inclusion Criteria:

Histologically proven diffuse large B-cell lymphoma non-GCB subtype. Previously treated with 1, and only 1, chemotherapy regimen including an anthracycline and excluding cisplatin, cytarabine, bortezomib and gemcitabine. Relapse after CR, less than PR or PR to previous treatment.
No history of stem cell transplantation, and no intention for stem cell transplantation.
Age between 16-75.
ECOG<3.
At least 1 measurable tumor mass.
Minimum life expectancy of 3 months.
Written informed consent.
No uncontrolled CNS involvement by lymphoma:No CNS disease at time of relapse;CNS disease diagnosed at initial presentation allowed provided a complete response for CNS disease was achieved and maintained.

Exclusion Criteria:

Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.
Clinically significant active infection.
Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.
Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
Patients who are pregnant or breast-feeding.
HIV infection.

Sites / Locations

Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

V-GDP

Arm Description

Bortezomib 1.6 mg/m2/d iv d1 and d8 Gemcitabine 1000mg/m2/d iv d1 and d8 Dexamethasone 40mg/d iv d1-4 cisplatin 25 mg/m2 iv d2-4 Frequency every 28 days Total cycles 4

Outcomes

Primary Outcome Measures

Response rate

28 days as one cycle

Secondary Outcome Measures

Progression free survival

Overall survival

Safety as assessed using the CTCAE

28 days as one cycle

Full Information

NCT ID

NCT02542111

First Posted

August 24, 2015

Last Updated

November 10, 2017

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02542111

Brief Title

A Study of Bortezomib Plus GDP in the Treatment of Refractory and Relapsed Non-GCB DLBCL

Official Title

A Phase II Study of the Efficacy and Safety of Bortezomib Plus GDP in the Treatment of Refractory and Relapsed Non-GCB Diffuse Large B-cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Unknown status

Study Start Date

May 2015 (undefined)

Primary Completion Date

May 2018 (Anticipated)

Study Completion Date

May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

5. Study Description

Brief Summary

This study is to evaluate the efficacy and safety of Bortezomib plus GDP in the treatment of non-GCB DLBCL patients.

6. Conditions and Keywords

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

Diffuse Large B-cell Lymphoma

Keywords

diffuse large b-cell lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

V-GDP

Arm Type

Experimental

Arm Description

Bortezomib 1.6 mg/m2/d iv d1 and d8 Gemcitabine 1000mg/m2/d iv d1 and d8 Dexamethasone 40mg/d iv d1-4 cisplatin 25 mg/m2 iv d2-4 Frequency every 28 days Total cycles 4

Intervention Type

Drug

Intervention Name(s)

Bortezomib

Intervention Description

Bortezomib IV

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

Gemcitabine IV

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Dexamethasone IV

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Cisplatin IV

Primary Outcome Measure Information:

Title

Response rate

Description

28 days as one cycle

Time Frame

Every 2 cycles during treatment and then every 3 months for 2 years

Secondary Outcome Measure Information:

Title

Progression free survival

Time Frame

1 year

Title

Overall survival

Time Frame

1 year

Title

Safety as assessed using the CTCAE

Description

28 days as one cycle

Time Frame

Days 1 of each course and 4-6 weeks after final treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically proven diffuse large B-cell lymphoma non-GCB subtype. Previously treated with 1, and only 1, chemotherapy regimen including an anthracycline and excluding cisplatin, cytarabine, bortezomib and gemcitabine. Relapse after CR, less than PR or PR to previous treatment. No history of stem cell transplantation, and no intention for stem cell transplantation. Age between 16-75. ECOG<3. At least 1 measurable tumor mass. Minimum life expectancy of 3 months. Written informed consent. No uncontrolled CNS involvement by lymphoma:No CNS disease at time of relapse;CNS disease diagnosed at initial presentation allowed provided a complete response for CNS disease was achieved and maintained. Exclusion Criteria: Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study. Clinically significant active infection. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule. Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures. Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment. Patients who are pregnant or breast-feeding. HIV infection.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Weili Zhao, Prof

Phone

64370045

Ext

610707

zhao.weili@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Pengpeng XU, MD

Phone

64370045

Ext

610707

xpproc@msn.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Weili Zhao, Prof

Organizational Affiliation

Ruijin Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ruijin Hospital

City

Shanghai

State/Province

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pengpeng XU, MD

Phone

64370045

Ext

610707

12. IPD Sharing Statement

Learn more about this trial

A Study of Bortezomib Plus GDP in the Treatment of Refractory and Relapsed Non-GCB DLBCL

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