Chidamide + R-GemOx Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory DLBCL

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04022005
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 50
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide with R-GemOx(rituximab、gemcitabine plus oxaliplatin) regimen in the treatment of transplant-ineligible patients with relapsed/refractory diffuse large B-cell lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Large B-Cell, Diffuse	Drug: Chidamide, Rituximab, Gemcitabine,Oxaliplatin	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 54 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Chidamide Combined With R-GemOx(Rituximab、Gemcitabine Plus Oxaliplatin) Regimen as Salvage Treatment for Transplant-ineligible Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma: a Multi-center, Single Arm, Phase II Study
• Actual Study Start Date: Jul 15, 2019
• Anticipated Primary Completion Date: Jul 15, 2023
• Anticipated Study Completion Date: Sep 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chidamide combined with R-GemOx Chidamide, 20 mg,twice per week; Rituximab 375mg/m2, d1, intravenous drip; Gemcitabine 1000mg/m2, d2, intravenous drip; Oxaliplatin 100mg/m2, d2,intravenous drip; All patients received up to 6 treatment cycles of 21 days. Patients with CR or PR will receive chidamide maintenance therapy.	Drug: Chidamide, Rituximab, Gemcitabine,Oxaliplatin; All patients enrolled in the study will accept Chidamide + R-GemOx (Rituximab, Gemcitabine and Oxaliplatin) as their salvage chemotherapy. Patients with CR or PR will receive chidamide maintenance therapy.

Outcome Measures

Primary Outcome Measures

1. ORR [4-years]

Secondary Outcome Measures

1. DOR [4-years]

2. DFS [4-years]

3. OS [4-years]

Other Outcome Measures

1. bio-marker analysis [4-years]

   Correlation between epigenetic factor mutation and efficacy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• biopsy proved CD20+ DLBCL;

• first relapse or refractory；

• previously received systemic chemotherapy with anthracycline；

• not eligible for autologous hematopoietic stem cell transplantation；

• at least one evaluable lesion；

• ECOG PS 0-1;

• 18-75 years; without other malignancy;

• proper functioning of the major organs.

Exclusion Criteria:

• double-hit lymphoma;

• previously received treatment of HDAC inhibitor;

• plan to receive autologous stem cell transplantation;

• involvement of central nervous system;

• previously received more than one chemotherapy regimen;

• patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong	China	51000

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qingqing Cai, Chief physician, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT04022005
• Other Study ID Numbers: B2019-091
• First Posted: Jul 16, 2019
• Last Update Posted: Aug 6, 2019
• Last Verified: Aug 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse; Gemcitabine; Rituximab; Oxaliplatin

Study Results

No Results Posted as of Aug 6, 2019