Avo In R/R And Previously Untreated MCL

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Austin I Kim
Study ID
NCT04855695
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Mantle Cell Lymphoma
  • Refractory Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acalabrutinib — DRUG
    Each study drug is given according to a different schedule: Acalabrutinib: Oral, dosage per protocol, start cycle 1 and beyond according to schedule outlined in protocol
  • Venetoclax — DRUG
    Venetoclax: oral. daily, dosage per protocol, start cycle 3 and beyond according to schedule outlined in protocol
  • Obinutuzumab — DRUG
    Obinutuzumab: intravenous infusion, dosage per protocol, drug during cycles 2 and beyond according to schedule outlined in protocol

Study Details

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

Key Dates

Start date
Jul 2, 2021
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Acalabrutinib, Venetoclax, and Obinutuzumab
    The study will consist of 4 parts (Parts A, B, C, and D). In the relapsed/refractory (R/R) MCL setting (Part A), the phase 1 portion consists of a dose finding stage to determine the recommended phase 2 dose (RP2D). It will follow a 3+3 dose finding schema with a minimum of 6 participants. 11 participants will be enrolled in the Part A expansion cohort. Part B will enroll 24 participants with untreated mantle cell lymphoma who are transplant ineligible and/or TP53 mutated. Part C will enroll 12 participants with untreated mantle cell lymphoma who are transplant eligible and TP53 wild type. Part D will enroll 16 participants with untreated mantle cell lymphoma with a TP53 mutation determined by next generation sequencing, regardless of transplant eligibility. Each study drug is given according to a different schedule. Each treatment cycle lasts 28 days (4 weeks). * Acalabrutinib: * Obinutuzumab: * Venetoclax:

Primary Outcome Measure

Recommended Phase 2 Dose for acalabrutinib [ Time Frame: 5 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Chicago Medical CenterChicagoIllinois60637
Peter Riedell, MD
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Jon Arnason, MD
617-667-9920
Dana-Farber Cancer InstituteBostonMassachusetts02215
Austin Kim, MD
(617) 632-6844
Austin Kim, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
University of Chicago Medical Center· Chicago, ILBeth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MA

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