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

Sun Yat-sen University

Status and phase: Completed; Phase 2

Conditions: Lymphoma, Large B-Cell, Diffuse

Treatments: Drug: Chidamide, Rituximab, Gemcitabine,Oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT04022005

B2019-091

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• biopsy proved CD20+ DLBCL;
• relapse or refractory DLBCL#
• 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 gemcitabine within the past 6 months;
• patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Chidamide combined with R-GemOx

Experimental group

Description:

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.

Treatment:

Drug: Chidamide, Rituximab, Gemcitabine,Oxaliplatin