Avo In R/R And Previously Untreated MCL
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAustin I Kim
About this trial
This research study is evaluating the combination of three drugs - acalabrutinib, venetoclax, and obinutuzumab - as a possible treatment for relapsed or refractory and untreated mantle cell lymphoma (MCL).
The names of the study drugs involved in this study are:
* Acalabrutinib * Venetoclax * Obinutuzumab
Eligibility criteria
Qualifiers
Relapsed or primary refractory after at least one line of therapy including anti-CD20 monoclonal antibody treatment (part A) or; Had no previous anti-lymphoma therapy other than corticosteroids or radiotherapy (parts B, C, and D).
Participants in part A, relapsed or refractory following prior therapy, may have had a prior autologous or allogeneic stem cell transplant and may have been treated with chimeric antigen receptor T-cells (CAR T-cells).
Symptomatic adenopathy or splenomegaly
Local symptoms due to extranodal disease
Disqualifiers
Participants who have progressed or relapsed after receiving either a BTK inhibitor or BCL2 inhibitor.
Participants who are receiving any other investigational agents, or have received investigational agents within 4 weeks (or 3 half-lives, whichever is longer) of beginning treatment.
Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., within 28 days of the first dose of study drug or chronic administration of >20 mg/day of prednisone equivalent corticosteroid within 7 days of the first dose)
History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to obinutuzumab, venetoclax, or acalabrutinib. Patients with reactions to other CD20 monoclonal antibodies (e.g. rituximab, ofatumumab) are not excluded if they were able to eventually tolerate treatment in an outpatient setting without grade 2 or higher infusion reactions.
Trial design
Treatments tested in this trial
- Acalabrutinib
- Venetoclax
- Obinutuzumab
Treatment groups
72 Participants
are divided into 1 treatment groupSponsors and collaborators
Austin I Kim
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Roche-Genentech
Collaborator
AstraZeneca
Collaborator
Source ClinicalTrials.gov