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A Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated DEL Under the Guidance of Genotyping

ConditionsDLBCL - Diffuse Large B Cell LymphomaDouble Expressor Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRuijin Hospital

About this trial

Evaluate the efficacy and safety of C Pola R-CHP+X compared to CR-CHOP in the treatment of previously untreated patients with DEL

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Histopathological diagnosis confirmed as diffuse large B-cell lymphoma, with CD20 positivity;

2. Simultaneous expression of MYC and BCL2, according to the WHO standard for immunohistochemistry: MYC ≥ 40%, BCL2 ≥ 50%

3. Age ≥ 18 years old and ≤ 75 years old;

4. ECOG performance status score of 0, 1, or 2;

Disqualifiers

1. Have previously received systemic or local treatments, including chemotherapy;

2. Have previously undergone autologous stem cell transplantation;

3. Previously had a history of other malignant tumors, excluding basal cell carcinoma and cervical carcinoma in situ;

4. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc;

Trial design

Design model

Parallel

Treatments tested in this trial

  • C-Pola-R-CHP+X

    Drug

    The experimental group first received one course of CR-CHOP regimen, and then the subsequent treatment was determined based on whether the ctDNA LFC reached 3 after one cycle of CR-CHOP treatment. Perform ctDNA detection at C1D14, and continue CR-CHOP treatment for patients with C1D14 ctDNA LFC ≥ 3 until 6 cycles. For patients with C1D14 ctDNA LFC \< 3, stratification is based on gene subtypes, namely C1, C2-3, and TP53mut, which determines the medication for the remaining 5 cycles. For C1 subtype, a PD1 inhibitor is added; for C2 and C3 subtypes, a BTK inhibitor is added; for TP53mut subtype, decitabine is added.

  • CR-CHOP

    Drug

    If assigned to the control group, they will continue to receive CR-CHOP for up to 6 cycles.

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: Innovative Treatment GroupExperimental treatment 1 intervention
Group B: CR-CHOPActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Complete remission (CR) rate

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

Secondary outcomes

1

2-year progression-free survival (PFS) rate

Time frame
2 years after enrollment
2

2-year overall survival (OS) rate

Time frame
2 years after enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: