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

NCT06750991 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: CSIIT-B45
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

DLBCL

Keywords

DLBCL; TP53; Chidamide

Outcome Measures

Primary Outcomes (1)

• PFS（Progression-free survival）

  PFS, defined as the time from treatment to the first occurrence of disease progression or relapse using the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first; as determined by the investigator

  1-year

Secondary Outcomes (3)

• CRR（Complete response rate）

  End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

• OS（overall survival）

  2-year

• ORR（overall response rate）

  End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

Study Arms (1)

CDR-CHOP

EXPERIMENTAL

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.

Drug: CDR-CHOP

Interventions

CDR-CHOP DRUG

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

CDR-CHOP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Histologically confirmed diffuse large B-cell lymphoma with CD20 positive;
• \. Pathologically confirmed a combination of TP53 mutation and del(17p);
• \. Age ≥ 18 years old, ≦75 years old;
• \. ECOG physical status score of 0, 1 or 2;
• \. No previous history of malignant tumors; No other tumors occurred simultaneously;
• \. Patients judged by the investigator to have a life expectancy of at least 6 months;
• \. The patient or his legal representative must provide written informed consent prior to any research special examination or procedure.
• \. International prognostic Index (IPI) \>1 score.

You may not qualify if:

• \. Have previously received systemic or local treatment including chemotherapy;
• \. Previously received autologous stem cell transplantation;
• \. Previous history of other malignant tumors, except skin basal cell carcinoma and cervical carcinoma in situ;
• \. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases;
• \. Primary central nervous system lymphoma;
• \. Left ventricular ejection fraction ≤ 50%;
• \. Laboratory test values at the time of screening (unless due to lymphoma); A. Neutrophils \<1.5\*109/L; B. Platelet \<75\*109/L; C. ALT or AST were 2 times higher than the upper limit of normal, AKP and bilirubin were 1.5 times higher than the upper limit of normal.
• D. Creatinine levels higher than 1.5 times the upper limit of normal
• \. Other concurrent and uncontrolled medical conditions that the investigator believes will affect patient participation in the study.
• \. Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;
• \. Pregnant or lactating women;
• \. People living with HIV.
• \. Patients with positive HbsAg test results need to undergo HBV DNA test, and can be enrolled before turning negative. In addition, if the HBsAg test result is negative, but the HBcAb test is positive (regardless of the HBsAb status), HBV DNA test should also be performed. If the result is positive, the treatment should also be negative before admission.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

No. 197 Ruijin 2nd Road, Huangpu District, Shanghai

Shanghai, Shanghai Municipality, China

Location

Central Study Contacts

Li Wang

CONTACT

18917762217; dr_wangli@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: December 31, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)