CR-CHOP+X in Previously Untreated DEL

NCT06701357 | Recruiting Phase 2 DMC

• 1 other identifier: CSIIT-B41
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-arm, open-label phase II clinical trial that evaluates the efficacy and safety of CR-CHOP regimen combined with different targeted drugs based on different molecular subtypes in newly diagnosed DEL patients.

Conditions

DLBCL

Keywords

DLBCL; double-expression; chidamide

Outcome Measures

Primary Outcomes (1)

• CRR（Complete response rate）

  CR rate at the end of treatment by FDG-PET defined as the proportion of participants with CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator

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

Secondary Outcomes (3)

• PFS（Progression-free survival）

  2-year

• 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 (3)

Cluster1 DEL：CR-CHOP+PD1 inhibitor

EXPERIMENTAL

Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of CR-CHOP, followed by stratification of the remaining 5 cycles based on genetic subtypes. C1 plus PD1 inhibitor.

Drug: CR-CHOP+PD1 inhibitor

Cluster 2 and 3 DEL：CR-CHOP plus Orelabrutinib

EXPERIMENTAL

Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of CR-CHOP, followed by stratification of the remaining 5 cycles based on genetic subtypes. C2 and C3 were treated with Orelabrutinib.

Drug: CR-CHOP + Orelabrutinib

Tp53 mut DEL：CR-CHOP plus Decitabine

EXPERIMENTAL

Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of CR-CHOP, followed by stratification of the remaining 5 cycles based on genetic subtypes.TP53mut plus decitabine.

Drug: CR-CHOP + decitabine

Interventions

CR-CHOP+PD1 inhibitor DRUG

Rituximab 375 mg/m2 D1； Cyclophosphamide 750mg/m2 D2； Doxorubicin 50mg/m2 D2； Vincristine 1.4 mg/m2 D2； Prednisone 60 mg/m2 D2-6； Chidamide 20mg/d D1,4,8,11； PD1 200mg D1

Cluster1 DEL：CR-CHOP+PD1 inhibitor

CR-CHOP + Orelabrutinib DRUG

Rituximab 375 mg/m2 D1； Cyclophosphamide 750mg/m2 D2； Doxorubicin 50mg/m2 D2； Vincristine 1.4 mg/m2 D2； Prednisone 60 mg/m2 D2-6； Chidamide 20mg/d D1,4,8,11； Orelabrutinib 150mg/qd D1-21

Cluster 2 and 3 DEL：CR-CHOP plus Orelabrutinib

CR-CHOP + decitabine DRUG

Rituximab 375 mg/m2 D1； Cyclophosphamide 750mg/m2 D2； Doxorubicin 50mg/m2 D2； Vincristine 1.4 mg/m2 D2； Prednisone 60 mg/m2 D2-6； Chidamide 20mg/d D1,4,8,11； Decitabine 10mg/m2 D-5 - -1

Tp53 mut DEL：CR-CHOP plus Decitabine

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;
• \. MYC and BCL2 are expressed simultaneously, WHO immunohistochemical standards: MYC≥40%, BCL2 ≥50%;
• \. 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

RECRUITING

MeSH Terms

Interventions

orelabrutinib; Decitabine

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Central Study Contacts

Li Wang

CONTACT

18917762217; dr_wangli@126.com

Study Design

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

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 22, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)