Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL

Part of paid clinical trials in Stamford, Connecticut.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03580928
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Chronic Lymphocytic Leukemia (CLL)

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    Venetoclax is an oral drug that blocks the function of a protein called BCL-2. CLL cancer cells are thought to depend on the BCL-2 protein for their survival. By blocking BCL-2, venetoclax may kill cancer cells or stop them from growing.
  • Obinutuzumab — DRUG
    Obinutuzumab is a type of drug called a monoclonal antibody. It targets a protein CD20 on the surface of the CLL cell, causing it to die
  • Acalabrutinib — DRUG
    Acalabrutinib is a type of drug called a kinase inhibitor. It blocks a type of protein called Bruton Tyrosine Kinase (BTK) that helps CLL cells live and grow

Study Details

This research study is evaluating the combination of three drugs - acalabrutinib, venetoclax, and obinutuzumab -- as a possible treatment for chronic lymphocytic leukemia (CLL). The drugs involved in this study are: * Acalabrutinib * Venetoclax * Obinutuzmab

Key Dates

Start date
Aug 7, 2018
Status verified
Jan 2026
Primary completion
Apr 10, 2024
Completion
Dec 31, 2027

Study Design

Enrollment
72 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Acalabrutinib/Venetoclax/Obinutuzumab (AVO) with non-high-risk CLL disease
    * Acalabrutinib will be administered orally twice daily at 100 mg bid * Venetoclax will be administered orally once daily, with dose ramp-up from 20 mg up to a final dose of 400 mg * Obinutuzumab will be administered as per standard of care for 6 months with dosing at 100 mg on cycle 1 day 1, 900 mg on cycle 1 day 2, and then 1,000 mg on cycle 1 days 8, 15, and day 1 of cycles 2-6
  • Experimental: Acalabrutinib/Venetoclax/Obinutuzumab (AVO) with high-risk CLL disease
    * Acalabrutinib will be administered orally twice daily at 100 mg bid * Venetoclax will be administered orally once daily, with dose ramp-up from 20 mg up to a final dose of 400 mg * Obinutuzumab will be administered as per standard of care for 6 months with dosing at 100 mg on cycle 1 day 1, 900 mg on cycle 1 day 2, and then 1,000 mg on cycle 1 days 8, 15, and day 1 of cycles 2-6. High-risk CLL disease (cohort 2), defined as 17p deletion and/or TP53 mutation

Primary Outcome Measure

Rate of Bone Marrow (BM) Minimal Residual Disease (MRD) Negative Complete Response (CR) After 15 Cycles [ Time Frame: BM biopsy evaluated at baseline, cycle 4, 8, 16 on day 1. Relative to this endpoint is after 15 cycles ]

Locations (4)

FacilityCityStateZIPSite coordinators
Stamford Hospital/Bennett Cancer CenterStamfordConnecticut06904-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Lifespan Cancer InstituteProvidenceRhode Island02903-

Find similar trials in Stamford, CT

By research site
Stamford Hospital/Bennett Cancer Center· Stamford, CTBeth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MALifespan Cancer Institute· Providence, RI

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