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CR-CHOP+X in Previously Untreated DEL

NCT ID: NCT06701357

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2028-12-01

Brief Summary

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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.

Detailed Description

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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; C2 and C3 were treated with orelabrutinib. TP53mut plus decitabine. During chemotherapy, routine evaluation was performed after each course of treatment, and an objective comprehensive evaluation of efficacy was performed after 3 courses of treatment. Efficacy evaluation Patients with CR or PR should continue the original treatment, and patients with SD or PD should be recommended second-line salvage treatment. For the first summary evaluation after completion of all treatments, CR patients are placed on chidamide maintenance therapy (2 years recommended unless intolerable toxicity or disease progression occurs).

Conditions

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DLBCL

Keywords

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DLBCL double-expression chidamide

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cluster1 DEL：CR-CHOP+PD1 inhibitor

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.

Group Type EXPERIMENTAL

CR-CHOP+PD1 inhibitor

Intervention Type 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

Cluster 2 and 3 DEL：CR-CHOP plus Orelabrutinib

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.

Group Type EXPERIMENTAL

CR-CHOP + Orelabrutinib

Intervention Type 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

Tp53 mut DEL：CR-CHOP plus Decitabine

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.

Group Type EXPERIMENTAL

CR-CHOP + decitabine

Intervention Type 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

Interventions

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CR-CHOP+PD1 inhibitor

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

Intervention Type DRUG

CR-CHOP + Orelabrutinib

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

Intervention Type DRUG

CR-CHOP + decitabine

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\. Histologically confirmed diffuse large B-cell lymphoma with CD20 positive;
* 2\. MYC and BCL2 are expressed simultaneously, WHO immunohistochemical standards: MYC≥40%, BCL2 ≥50%;
* 3\. Age ≥ 18 years old, ≦75 years old;
* 4\. ECOG physical status score of 0, 1 or 2;
* 5\. No previous history of malignant tumors; No other tumors occurred simultaneously;
* 6\. Patients judged by the investigator to have a life expectancy of at least 6 months;
* 7\. The patient or his legal representative must provide written informed consent prior to any research special examination or procedure;
* 8\. International prognostic Index (IPI) \>1 score.

Exclusion Criteria

* 1\. Have previously received systemic or local treatment including chemotherapy;
* 2\. Previously received autologous stem cell transplantation;
* 3\. Previous history of other malignant tumors, except skin basal cell carcinoma and cervical carcinoma in situ;
* 4\. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases;
* 5\. Primary central nervous system lymphoma;
* 6\. Left ventricular ejection fraction ≤ 50%;
* 7\. 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;
* 8\. Other concurrent and uncontrolled medical conditions that the investigator believes will affect patient participation in the study;
* 9\. Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;
* 10\. Pregnant or lactating women;
* 11\. People living with HIV;
* 12\. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhao Weili

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Wang

Role: CONTACT

Phone: 18917762217

Email: [email protected]

Facility Contacts

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Li Wang

Role: primary

Other Identifiers

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CSIIT-B41

Identifier Type: -

Identifier Source: org_study_id