Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell … (NCT04783415) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma
United States12 participantsStarted 2021-03-26
Plain-language summary
This phase II trial studies the effects of acalabrutinib, umbralisib, and ublituximab in treating previously untreated mantle cell lymphoma. Acalabrutinib and umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Ublituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving acalabrutinib and umbralisib with ublituximab may work better in treating mantle 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:
* Documented informed consent of the participant and/or legally authorized representative
* Assent, when appropriate, will be obtained per institutional guidelines
* Histologically confirmed mantle cell lymphoma with documentation of monoclonal CD20+ B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1
* Age \>= 65 years; or \>= 50 years and deemed ineligible for aggressive induction therapy or autologous stem cell transplant by the investigator, or unwilling to undergo aggressive induction; or \>= 18 years with documented del(17p), or TP53 mutation, or complex karyotype (CK) by cytogenetics and/or fluorescence in situ hybridization (FISH) studies
* Requiring treatment for MCL, and for which no prior systemic anticancer therapies have been received (local radiotherapy not exceeding a total dose of 20 Gy at least 2 weeks prior the first dose of study therapy is allowed)
* Measurable disease by computed tomography (CT) or positron emission tomography (PET)/CT scan with one or more sites of disease \>= 1.5 cm in longest dimension (including splenomegaly), or bone marrow involvement with or without malignant lymphocytosis
* Without bone marrow involvement: Absolute neutrophil count (ANC) \>= 1000/mm\^3
* NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement
* With bone marrow involvement: ANC \>= 500/mm\^3
* NOTE: Growth factor is not permitted …
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.
1This trial combines three drugs — acalabrutinib, umbralisib, and ublituximab — for mantle cell lymphoma that hasn't been treated yet. Can you explain how this combination is different from the standard first-line treatment options you'd recommend for me, and why one approach might be better suited to my situation?
2Since this is a Phase 2 trial, it's still building evidence on how well this combination works and what side effects to expect — how does that level of uncertainty compare to what's already known about standard treatments for my type of mantle cell lymphoma?
3The trial is measuring whether patients achieve a complete response after six cycles of treatment — if I were in this trial and didn't reach a complete response, what would my options be at that point?
4The trial is no longer enrolling new patients, so is there any chance I could still be considered for participation, or would my doctor recommend a different trial or standard therapy that targets similar pathways?
5All three drugs in this trial work on the immune system and cancer cells in different ways — given my overall health and any other conditions I have, what specific side effects or risks should I be most aware of if this combination were part of my treatment plan?
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
Complete Response (CR) Rate After Induction (Six Cycles)
Timeframe: Participants were assessed at the end of the induction therapy (24 weeks post-baseline). The induction therapy included six 28-day cycles of the study treatment.