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

First listed
Jul 10, 2018
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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