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New treatment option for DLBCL
Official title CR-CHOP+X in Previously Untreated DEL
ClinicalTrials.gov ID: NCT06701357
What this study is testing
What is CR-CHOP+PD1 inhibitor?
CR-CHOP+PD1 inhibitor is an investigational medicine, being studied as a potential treatment for dlbcl.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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;
You likely can't join if
- 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...
- 5\. Primary central nervous system lymphoma;
- 6\. Left ventricular ejection fraction ≤ 50%;
See the full eligibility 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.
- 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...
- 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 study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.