Health TrialsbyHealthPanel

CR-CHOP+X in Previously Untreated DEL

ConditionDLBCL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRuijin Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

  • 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

Treatment groups

49 Participants
are divided into 3 treatment groups
Group A: Cluster1 DEL：CR-CHOP+PD1 inhibitorExperimental treatment 1 intervention
Group B: Cluster 2 and 3 DEL：CR-CHOP plus OrelabrutinibExperimental treatment 1 intervention
Group C: Tp53 mut DEL：CR-CHOP plus DecitabineExperimental treatment 1 intervention

Trial outcomes

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

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

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

Time frame
2-year
2

OS（Overall survival）

OS defined as the time from treatment to death from any cause

Time frame
2-year
3

ORR（Overall response rate）

ORR at treatment completion or discontinuation defined as the proportion of participants with partial response (PR) or CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator

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

Other outcomes

Sponsors and contacts

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

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov
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