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New treatment option for Mantle Cell Lymphoma
Official title Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy
ClinicalTrials.gov ID: NCT07341191
What this study is testing
What is Zanubrutinib?
Zanubrutinib is an investigational medicine, given as a 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
- The purpose of this study is to evaluate the effects of adding two oral medications (sonrotoclax plus zanubrutinib) to standard of care chimeric antigen receptor (CAR-T) cell therapy in participants with mantle cell lymphoma.
- 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 and older
You may be able to join if
- Have histologically confirmed mantle cell lymphoma that is relapsed or refractory after at least one prior line of systemic therapy
- Eligible for and planned to receive Health Canada approved CAR-T.
- Have a formalin fixed paraffin embedded tumour tissue block available and must have provided informed consent for the release of the block.
- Presence of radiologically documented disease.
- Measurable disease (one site bidimensionally measurable).
You likely can't join if
- Participants on active anticancer therapy for other advanced or metastatic malignancies.
- Concurrent treatment with other anti-cancer therapy
- Serious illnesses or medical conditions which would not permit the participant to be managed according to the protocol.
- Known hypersensitivity to the study drug(s) or their components.
- Prior CD19-directed CAR-T at any time, autologous hematopoietic cell transplantation within 6 weeks, or allogeneic hematopoietic cell transplantation...
- Untreated and/or uncontrolled cardiovascular conditions and/or symptomatic cardiac dysfunction (including cardiac ventricular arrhythmias requiring...
See the full eligibility criteria
- Have histologically confirmed mantle cell lymphoma that is relapsed or refractory after at least one prior line of systemic therapy
- Eligible for and planned to receive Health Canada approved CAR-T.
- Have a formalin fixed paraffin embedded tumour tissue block available and must have provided informed consent for the release of the block.
- Presence of radiologically documented disease.
- Measurable disease (one site bidimensionally measurable).
- Age ≥ 18 years.
- Have an ECOG performance status of 0, 1 or 2
- Anticipated life expectancy of ≥ 6 months
- Adequate hematologic and biochemical parameters
- Must have received prior systemic therapy as shown below;
- At least one line of systemic therapy including a Bruton's Tyrosine Kinase inhibitor (BTKi).
- Participants who have previously received venetoclax, sonrotoclax, or any other BCL2 inhibitor (BCL2i) are eligible as long as progressive disease did not occur within 6 months of the last dose of BCL2i. Participants...
- Participants must enter the study while on a BTKi or enroll to a substudy of the protocol to receive zanubrutinib for a minimum duration prior to enrolling to the main study.
- Participants previously exposed to zanubrutinib are eligible irrespective of response to treatment.
- Participants entering the study while on a BTKi must have their BTKi switched to zanubrutinib supplied through the study.
- Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior therapies.
- Adequate washout must be followed per protocol.
- Prior high-dose myelosuppresive radiation is permitted ≥28 prior to enrollment.
- Previous major surgery is permitted ≥28 days prior to enrollment. Participants of childbearing potential must have agreed to use a highly effective contraceptive method.
- Participants on active anticancer therapy for other advanced or metastatic malignancies.
- Concurrent treatment with other anti-cancer therapy
- Serious illnesses or medical conditions which would not permit the participant to be managed according to the protocol.
- Known hypersensitivity to the study drug(s) or their components.
- Prior CD19-directed CAR-T at any time, autologous hematopoietic cell transplantation within 6 weeks, or allogeneic hematopoietic cell transplantation within 3 months. Allogeneic hematopoietic cell transplantation...
- Untreated and/or uncontrolled cardiovascular conditions and/or symptomatic cardiac dysfunction (including cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction...
- Active, uncontrolled bacterial, fungal, or viral infection within 14 days prior to enrollment
- Pregnant or breastfeeding women.
- Inability to discontinue use of moderate or strong CYP3A inducers or inhibitors during the ramp-up treatment period with sonrotoclax.
- Live vaccination within 4 weeks prior to enrollment or who plan to receive a live vaccine during treatment or within 90 days post last dose.
- Inability to swallow capsules or tablets or have any diseases significantly affecting GI function
- Active central nervous system (CNS) disease; Participants with stable CNS disease are eligible.
- Growth factors within 28 days prior to enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
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 Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Toronto, Ontario, Canada. 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.