NCT06750991

CD-RCHOP in ND DLBCL With a Combination of TP53 Mutation and Del(17p)

A Prospective, Open-label Phase II Study of Chidamide, Decitabine Plus R-CHOP in Previously Untreated Diffuse Large B-cell Lymphoma With a Combination of TP53 Mutation and Del(17p)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This was an open, multicenter clinical study of newly treated DLBCL patients with TP53 mutations and del(17p) with IPI\>1. Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of R-CHOP, followed by the remaining 5 cycles courses of chidamide and decitabine combined with a standard-dose R-CHOP regimen.

Detailed description

This was an open, multicenter clinical study of newly treated DLBCL patients with TP53 mutations and del(17p) with IPI\>1. Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of R-CHOP, followed by the remaining 5 cycles courses of chidamide and decitabine combined with a standard-dose R-CHOP regimen. . Patients who achieve CR will continue with chidamide maintenance therapy (20mg, D1,4,8,11) or opt for autologous hematopoietic stem cell transplantation after completion of induction therapy, with maintenance therapy recommended for at least 1 year (unless intolerable side effects or disease progression occur). Concurrent follow-up assessment (patients will enter the follow-up period described in the time and event table) until the end of the specified follow-up period (total study duration is 3 years) or until the patient meets the exit criteria.

Conditions

• DLBCL

Interventions

Type	Name	Description
DRUG	CDR-CHOP	Rituximab 375 mg/m2 D1 Cyclophosphamide 750 mg/m2 D2 Doxorubicin 50 mg/m2 D2 Vincristine 1.4 mg/m2 D2 Prednisone 69 mg.m2 D2-6 Chidamide 20 mg/d D1,4,8,11 Decitabine 10 mg/m2 D-5 - -1

Timeline

• Start date: 2024-12-31
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2024-12-27
• Last updated: 2024-12-27

Locations

1 site across 1 country: China