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Compares treatment options for Mantle Cell Lymphoma
Official title A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma
ClinicalTrials.gov ID: NCT07377578
What this study is testing
What is Rocbrutinib?
Rocbrutinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for mantle 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
- Mantle cell lymphoma (MCL) is an aggressive yet often indolent type of B-cell non-Hodgkin lymphoma (NHL). Rocbrutinib (LP-168) is a novel, highly selective, fourth-generation Bruton's tyrosine kinase (BTK) inhibitor that exhibits both covalent (irreversible) and non-covalent (reversible) binding.
- 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 18 and older
You may be able to join if
- Diagnosed with MCL, who have received at least one prior systemic regimen(s), and have experienced disease progression on the most recent line of...
- Have at least one measurable lesion according to the Lugano Response Criteria 2014.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2.
- Life expectancy ≥ 12 weeks.
- Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function, etc.
You likely can't join if
- Hypersensitivity to Rocbrutinib or any study drug in the control group.
- Prior treatment with any BTK-targeted therapy (except for intolerance).
- Central nervous system (CNS) involvement by lymphoma.
- History of other malignancy (except MCL) within the past 2 years, excluding radically cured skin basal cell carcinoma, cervical carcinoma in situ...
- History of major cardiovascular events within 6 months prior to randomization.
- Presence of any severe and/or uncontrolled systemic disease that, in the investigator's judgment, or have poor cardiac function.
See the full eligibility criteria
- Diagnosed with MCL, who have received at least one prior systemic regimen(s), and have experienced disease progression on the most recent line of therapy.
- Have at least one measurable lesion according to the Lugano Response Criteria 2014.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2.
- Life expectancy ≥ 12 weeks.
- Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function, etc.
- Toxicities or complications from prior anti-tumor therapy have recovered to Grade ≤1 according to NCI CTCAE v5.0.
- All male people and female people of childbearing potential must strictly use medically approved contraception throughout the entire study period. All male people must also avoid sperm donation during the above period...
- Subject voluntarily enrolls and signs the informed consent form, and agrees to comply with the study treatment plan and visit schedule.
- Hypersensitivity to Rocbrutinib or any study drug in the control group.
- Prior treatment with any BTK-targeted therapy (except for intolerance).
- Central nervous system (CNS) involvement by lymphoma.
- History of other malignancy (except MCL) within the past 2 years, excluding radically cured skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, localized squamous cell carcinoma, etc.
- History of major cardiovascular events within 6 months prior to randomization.
- Presence of any severe and/or uncontrolled systemic disease that, in the investigator's judgment, or have poor cardiac function.
- Uncontrolled active bacterial, fungal, or viral systemic infection, or active tuberculosis infection.
- Any medical condition that could interfere with the absorption, distribution, metabolism, or excretion (ADME) of the investigational drug or the evaluation of study outcomes.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Nanning, Guangxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Nanning, Guangxi, 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.