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CD-RCHOP in ND DLBCL With a Combination of TP53 Mutation and Del(17p)

ConditionDLBCL
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRuijin Hospital

About this trial

This was an open, multicenter clinical study of newly treated DLBCL patients with TP53 mutations and del(17p) with IPI\>1. Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of R-CHOP, followed by the remaining 5 cycles courses of chidamide and decitabine combined with a standard-dose R-CHOP regimen.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Histologically confirmed diffuse large B-cell lymphoma with CD20 positive;

2. Pathologically confirmed a combination of TP53 mutation and del(17p);

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

Single group

Treatments tested in this trial

  • CDR-CHOP

    Drug

    Rituximab 375 mg/m2 D1 Cyclophosphamide 750 mg/m2 D2 Doxorubicin 50 mg/m2 D2 Vincristine 1.4 mg/m2 D2 Prednisone 69 mg.m2 D2-6 Chidamide 20 mg/d D1,4,8,11 Decitabine 10 mg/m2 D-5 - -1

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: CDR-CHOPExperimental treatment 1 intervention

Trial outcomes

Primary 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
1-year

Secondary 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]
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

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