BridgeMD
Compares treatment options for Diffuse Large B Cell Lymphoma
Official title The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk
ClinicalTrials.gov ID: NCT05018520
What this study is testing
What is Six Courses of R-CHOP Plus Two Courses of Rituximab?
Six Courses of R-CHOP Plus Two Courses of Rituximab is an investigational medicine, being studied as a potential treatment for diffuse large b cell lymphoma.
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
- The Safety and Effectiveness of Four Courses of R-CHOP Plus Four Courses of Rituximab Versus Six Courses of R-CHOP Plus Two Courses of Rituximab in the Treatment of Naive, Low-risk, Non-mass Diffuse Large B-cell Lymphoma: a Multi-center, Prospective, Randomized Controlled Study
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 75
You may be able to join if
- Pathologically confirmed CD20 positive DLBCL based on 2016 WHO classification who achieved CR after 4 cycles of RCHOP therapy (examined by PET-CT...
- Treatment naïve
- IPI=0,1
- Age ≥ 14 or ≤75 years
- non-mass (The length of the lesion\<7.5cm)
You likely can't join if
- Have received systemic or local treatment including chemotherapy in the past
- Have received autologous stem cell transplantation in the past
- Past medical history of other malignant tumors, except basal cell carcinoma of the skin and cervical cancer in situ
- Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases, severe infectious diseases and...
- Primary skin, primary central nervous system lymphoma
- Left ventricular ejection fraction ≦50%
See the full eligibility criteria
- Pathologically confirmed CD20 positive DLBCL based on 2016 WHO classification who achieved CR after 4 cycles of RCHOP therapy (examined by PET-CT, Deauville score 1-2)
- Treatment naïve
- IPI=0,1
- Age ≥ 14 or ≤75 years
- non-mass (The length of the lesion\<7.5cm)
- ECOG=0,1
- Life expectancy\>6 months
- Informed consented
- Have received systemic or local treatment including chemotherapy in the past
- Have received autologous stem cell transplantation in the past
- Past medical history of other malignant tumors, except basal cell carcinoma of the skin and cervical cancer in situ
- Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases, severe infectious diseases and other diseases
- Primary skin, primary central nervous system lymphoma
- Left ventricular ejection fraction ≦50%
- Other concurrent and uncontrolled situation which will affect the patient's medical status based on researchers decision
- Laboratory test value during screening: (unless it is caused by lymphoma) Neutrophils \<1.5\ 109/L Platelet\<80\ 109/L Hemoglobin \<100g/L ALT or AST is 2 times higher than the upper limit of normal, AKP and bilirubin...
- Psychiatric patients or other patients who are known or suspected to be unable to fully accomplish with the research protocol
- Pregnant or lactating women
- Patients with positive HbsAg test results need to undergo HBV-DNA test and can be admitted to the group after turning negative. In addition, if the HBsAg test result is negative, but the HBcAb test is positive...
- Patients living with HIV
- Patients with TP53 mutations or those who have not undergone DLBCL hot spot gene screening
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, 14 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.