R-CMOP in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma (NCT06594640) | Clinical Trial Compass
RecruitingPhase 1/2
R-CMOP in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma
China108 participantsStarted 2024-05-30
Plain-language summary
This is a prospective clinical study to evaluate the safety and efficacy of R-CMOP in patients with newly diagnosed diffuse large B-cell lymphoma
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years;
. Histologically confirmed newly diagnosed diffuse large B-cell lymphoma;
. Patients must have been untreated, including chemotherapy, targeted therapy, immunotherapy, radiotherapy;
. There must be at least one measurable lesion per the Lugano2014 criteria；
. For lymph lesion, the long axis must be greater than 1.5cm with 18F-deoxyglucose (18FDG) PET-CT positive；
. Ann Arbor stages II-IV；
. ECOG score 0\~2；
. Expected survival time ≥3 months;
Exclusion criteria
. Primary central nervous system DLBCL, Primary testicular large B-cell lymphoma, Primary mediastinal (thymic) large B-cell lymphoma, Lymphomatoid granulomatosis, ALK-positive large B-cell lymphoma, Plasmablastic lymphoma, HHV8-positive DLBCL, Primary effusion lymphoma, Intravascular large B-cell lymphoma, B-cell lymphoma unclassifiable between DLBCL and classical Hodgkin lymphoma, T-cell/histiocyte-rich large B-cell lymphoma, and High-grade B-cell lymphoma；
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase I:Maximum tolerated dose (MTD)
Timeframe: Through the last patient complete his DLT observation, assessed up to 21 days
2
Phase I: Recommended phaseII dose (RP2D)
Timeframe: Through the last patient complete his DLT observation, assessed up to 21 days
3
Phase II:Complete remission rate (CRR)
Timeframe: up to 2 years
4
Phase I: Dose limited toxicities (DLTs)
Timeframe: Through the last patient complete his DLT observation, assessed up to 21 days
Trial details
NCT IDNCT06594640
SponsorInstitute of Hematology & Blood Diseases Hospital, China
. Patients with active central nervous system involvement;
. History of hematopoietic stem cell transplantation;
. Have received prior anti-lymphoma treatment, excluding short-term or low-dose corticosteroids.;
. Used any NMPA-approved anticancer herbal medicines or proprietary Chinese medicines within 14 days prior to the first dose;
. History of allergy and contraindications to the same class and excipients of the experimental drug;
. Participating in any other intervention clinical trials within 4 weeks prior to the first dose except for participation in an observational (non-interventional) clinical study or the follow-up phase of an interventional study;