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

Lymphoma, Large B-Cell, Diffuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04021992
• Other study ID #: B2019-088
• Status: Recruiting
• Phase: Phase 2
• Start date: July 15, 2019
• Est. completion date: December 15, 2023

Study information

• Verified date: August 2019
• Source: Sun Yat-sen University
• Contact: Qingqing Cai, MD
• Phone: 0086-20-87342823
• Email: caiqq[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Large B-Cell, Diffuse

Intervention

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.

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR		4-years
Secondary	success rates in autologous stem cell mobilization		4-years
Secondary	PFS		4-years
Secondary	EFS		4-years
Secondary	OS		4-years