Clinical trial · Interventional
CR-CHOP+X in Previously Untreated DEL
A Prospective, Open-label Phase II Study of Chidamide Plus R-CHOP + X in Previously Untreated Diffuse Large B-cell Lymphoma with Double Expression of MYC and BCL2.
NCT06701357CI-TRIAL-00084169recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DLBCL | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CR-CHOP + decitabine | Drug | — | UNRESOLVED |
| CR-CHOP + Orelabrutinib | Drug | — | UNRESOLVED |
| CR-CHOP+PD1 inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cluster1 DEL:CR-CHOP+PD1 inhibitor
- description
- Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of CR-CHOP, followed by stratification of the remaining 5 cycles based on genetic subtypes. C1 plus PD1 inhibitor.
- interventionNames
- Drug: CR-CHOP+PD1 inhibitor
- type
- EXPERIMENTAL
- label
- Cluster 2 and 3 DEL:CR-CHOP plus Orelabrutinib
- description
- Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of CR-CHOP, followed by stratification of the remaining 5 cycles based on genetic subtypes. C2 and C3 were treated with Orelabrutinib.
- interventionNames
- Drug: CR-CHOP + Orelabrutinib
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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; * 5\. No previous history of malignant tumors; No other tumors occurred simultaneously; * 6\. Patients judged by the investigator to have a life expectancy of at least 6 months; * 7\. The patient or his legal representative must provide written informed consent prior to any research special examination or procedure; * 8\. International prognostic Index (IPI) \>1 score. Exclusion Criteria: * 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; * 5\. Primary central nervous system lymphoma; * 6\. Left ventricular ejection fraction ≤ 50%; * 7\. Laboratory test values at the time of screening (unless due to lymphoma): A. Neutrophils \<1.5\*109/L; B. Platelet \<75\*109/L; C. ALT or AST were 2 times higher than the upper limit of normal, AKP and bilirubin were 1.5 times higher than the upper limit of normal; D. Creatinine levels higher than 1.5 times the upper limit of normal; * 8\. Other concurrent and uncontrolled medical conditions that the investigator believes will affect patient participation in the study; * 9\. Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol; * 10\. Pregnant or lactating women; * 11\. People living with HIV; * 12\. Patients with positive HbsAg test results need to undergo HBV DNA test, and can be enrolled before turning negative. In addition, if the HBsAg test result is negative, but the HBcAb test is positive (regardless of the HBsAb status), HBV DNA test should also be performed. If the result is positive, the treatment should also be negative before admission.
References
Publications (0)
Data not yet available
No reference posted for this study.