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Study on the Treatment of Double/Triple-hit DLBCL With Chidamide and Lisaftoclax in Combination With Pola-R-CHP

ConditionsDHLTHLDLBCL - Diffuse Large B Cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorRuijin Hospital

About this trial

This is an open-label, multicenter clinical study for patients aged 65 and above with double/triple-hit diffuse large B-cell lymphoma who are not suitable for transplantation. The study employs a 6-cycle CL-Pola-R-CHP regimen, with cycles repeated every 21 days.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Double or triple hit confirmed by pathology;

Age ≥ 65 years old;

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

Disqualifiers

There is a history of other malignant tumors, excluding basal cell carcinoma and cervical carcinoma in situ;

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

Primary central nervous system lymphoma;

Left ventricular ejection fraction (LVEF) is less than or equal to 50%;

Trial design

Design model

Single group

Treatments tested in this trial

  • CL-Pola-R-CHP

    Drug

    R 375 mg/m2 D1 Pola 1.8mg/kg D1 CTX 750mg/m2 D2 ADR 50mg/m2 D2 Pred 60 mg/m2 D2-6 Chidamide 20mg/d D1,4,8,11 Lisaftoclax 600mg/d D1-21

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Treatment GroupExperimental treatment 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

1-year progression-free survival (PFS) rate

Time frame
1 years after enrollment
2

2-year overall survival (OS) rate

Time frame
2 years after enrollment

Other outcomes

Locations

This trial has no locations.

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: