A Phase 2 interventional study of R-CHOP + X in Diffuse Large B Cell Lymphoma (DLBCL), sponsored by Ruijin Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Ruijin Hospital · Phase 2, Interventional, and Treatment
This is a prospective, single-arm, noninferiority trial involving patients with previously untreated CD20-positive DLBCL. The aim of this study is to determine the efficacy and safety of treatment stratified based on ctDNA dynamic changes after one cycle of chemotherapy and the targeted therapy based on DLBCL genotype.
A total of 108 patients were planned to be enrolled in this trial, and the patients were stratified according to the dynamic changes of ctDNA after one cycle of chemotherapy: the chemotherapy-sensitive group continued the original R-CHOP regimen, and the potential drug resistance group received genotype-guided targeted drug combination. The whole trial included a screening period (day -28 to day -1), a treatment period, and a 2-year follow-up period.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 108 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
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Exclusion Criteria:
Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):
Drug: R-CHOP + X
Eligible participants will receive 1 cycle of R-CHOP therapy with genotyping and ctDNA testing at C1D14. Chemotherapy sensitive patients with C1D14 ctDNA negative or ctDNA LFC ≥ 2 will continue to receive R-CHOP therapy for up to 6 courses. Potentially resistant patients with C1D14 ctDNA positive and LFC \< 2 were stratified by DLBCL genotyping and treated with cycle 2-6 R-CHOP in combination with obutinib or decitabine or lenalidomide or Chidamide.
Complete response (CR) rate
CR rate at the end of treatment. Defined as the proportion of participants who achieved CR at the end of treatment.
Time frame: End of Cycle 6 (each cycle is 21 days)
2-year progression-free survival (PFS) rate
PFS, defined as the time from enrollment 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. The 2-year PFS rate was the percentage of patients who did not experience disease progression or death within two years of enrollment.
Time frame: 2 years
2-year Overall survival (OS) rate
OS defined as the time from enrollment to death from any cause. The 2-year OS rate was the percentage of patients who did not die within two years of enrollment.
Time frame: 2 years
The incidence and severity of adverse events were determined according to the NCI CTCAE v5.0 rating scale
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: From enrollment to study completion, a maximum of 4 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Ruijin Hospital