RecruitingPhase 2NCT06701357

CR-CHOP+X in Previously Untreated DEL

A Prospective, Open-label Phase II Study of Chidamide Plus R-CHOP + X in Previously Untreated Diffuse Large B-cell Lymphoma with Double Expression of MYC and BCL2.

Sponsor

Ruijin Hospital

Enrollment

49 participants

Start Date

Dec 10, 2024

Study Type

INTERVENTIONAL

Conditions

DLBCL

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination of treatments — including a drug called rituximab plus chemotherapy and other targeted agents — for people newly diagnosed with a particularly aggressive form of large B-cell lymphoma (a type of blood cancer) that is driven by two specific genetic markers (MYC and BCL2). **You may be eligible if...** - You are between 18 and 75 years old - You have newly diagnosed diffuse large B-cell lymphoma that is positive for both MYC and BCL2 proteins - You have not had any previous cancer treatment - You are in reasonably good physical health - Your international prognostic score (a measure of disease severity) is greater than 1 **You may NOT be eligible if...** - You have previously received systemic cancer treatment or a stem cell transplant - You have another active cancer - You have uncontrolled heart, blood clotting, or serious infectious conditions - Your heart pumping function is reduced (ejection fraction 50% or less) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCR-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

DRUGCR-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

DRUGCR-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

Locations(1)

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

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06701357

Related Trials

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

NCT05139017121 locations

P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies

NCT0601476217 locations

Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma

NCT045127167 locations

A Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma

NCT037589891 location

A Real-world Data and Sample Compendium of Frail and/or Multiply Treated Large B-cell Lymphoma

NCT073351201 location