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

NCT ID: NCT04021992

Last Updated: 2019-08-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-15
• Study Completion Date: 2023-12-15

Brief Summary

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.

Conditions

Lymphoma, Large B-Cell, Diffuse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab

Intervention Type: DRUG

All patients enrolled in the study will accept gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab as their salvage chemotherapy.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Qingqing Cai

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qingqing Cai, MD

Role: CONTACT

caiqq@sysucc.org.cn

0086-20-87342823

Facility Contacts

Zhihua LI, MD

Role: primary

Other Identifiers

B2019-088

Identifier Type: -

Identifier Source: org_study_id