GVD±R Regimen for ASCT-eligible Patients With Refractory/Relapsed DLBCL

August 3, 2019 updated by: Qingqing Cai, Sun Yat-sen University

GVD±R (Gemcitabine, Oral Vinorelbine and Doxorubicin Liposome, With or Without Rituximab) Regimen for Autologous Hematopoietic Stem Cell Transplantation(ASCT)-Eligible Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma:a Multi-center, Single Arm, Phase II Study

The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of GVD±R (gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab) regimen for autologous hematopoietic stem cell transplantation(ASCT)-eligible patients with refractory/relapsed diffuse large B-cell lymphoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • biopsy proved CD20+ DLBCL;
  • previously received at least one systemic treatment (including chemotherapy) without remission or relapse after remission;
  • at least one evaluable lesion；
  • ECOG PS 0-1;
  • 18-65 years;
  • proper functioning of the major organs.

Exclusion Criteria:

  • involvement of central nervous system;
  • with other malignancy;
  • patients receiving or received drug of other clinical trial within 30 days；
  • previously received doxorubicin liposome or have used other anthracycline drug with accumulated restricted doses (adriamycin 450mg/m2, epirubicin 935mg/m2, acrarubicin 900mg/m2)；
  • patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;
  • grade 2 or more peripheral neuropathy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GVD with or without R
Gemcitabine 1000mg/m2, d1,d8, intravenous drip; Vinorelbine 50mg/m2, d1,d8, oral; Doxorubicin liposomes 30mg/m2, d1,intravenous drip; With or without rituximab 375 mg/m2, d0,intravenous drip; All patients received up to 6 treatment cycles of 21 days.
Drug: gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab
All patients enrolled in the study will accept gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab as their salvage chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ORR
Time Frame: 4-years
4-years

Secondary Outcome Measures

Outcome Measure
Time Frame
OS
Time Frame: 4-years
4-years
success rates in autologous stem cell mobilization
Time Frame: 4-years
4-years
PFS
Time Frame: 4-years
4-years
EFS
Time Frame: 4-years
4-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 15, 2019

Primary Completion (ANTICIPATED)

July 15, 2023

Study Completion (ANTICIPATED)

December 15, 2023

Study Registration Dates

First Submitted

July 13, 2019

First Submitted That Met QC Criteria

July 13, 2019

First Posted (ACTUAL)

July 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 3, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2019-088

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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