CHiR Therapy for Elderly DLBCL Intolerant to Chemo
ConditionDiffuse Large B-Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age70-100
SponsorFirst Affiliated Hospital of Ningbo University
About this trial
The objective of exploring the application of CHiR is to evaluate its therapeutic efficacy and safety in newly diagnosed elderly patients with diffuse large B-cell lymphoma (DLBCL) aged 70 and above, and to investigate the genetic subtypes that may benefit from CHiR. The primary endpoint is the complete remission rate (CRR) at the end of 8 cycles.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 70 years;
ECOG score of 0-3;
Rated as unfit or frail on the simplified geriatric assessment (sGA);
Histologically confirmed CD20-positive diffuse large B-cell lymphoma (diagnostic criteria according to WHO 2016), excluding transformed type 2 DLBCL;
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
CHiR-DEL
DrugUsing the combined regimen of CHiR (chidamide, zanubrutinib, and lenalidomide) to treat newly diagnosed elderly patients with MYC- and BCL2-expressing positive diffuse large B-cell lymphoma (DLBCL) who are intolerant to chemotherapy.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: CHiRExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
the complete remission rate (CRR)
The primary endpoint is the complete remission rate (CRR) at the end of 8 cycles.
Time frame
Each cycle consists of 21 days, with a total of 8 cycles.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov