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Kinase Inhibitor

Triple-Drug Therapy for CLL (AVO Trial)

Phase 2

Waitlist Available

Led By Matthew S. Davids, MD, MMSc

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status ≤2

Age greater than or equal to 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

AVO Trial Summary

This trial is testing whether or not the combination of these three drugs is effective in treating CLL.

Who is the study for?

Adults with chronic lymphocytic leukemia (CLL) who haven't had prior treatment and meet specific health criteria, such as adequate organ function and no severe allergies to the study drugs. They must have symptoms or blood test changes that require treatment for CLL.Check my eligibility

What is being tested?

The trial is testing a combination of three drugs: Acalabrutinib, Venetoclax, and Obinutuzumab. It aims to evaluate their effectiveness when used together as an initial therapy for patients with CLL.See study design

What are the potential side effects?

Possible side effects include diarrhea, headache, increased risk of infection due to low white blood cell count, nausea, fatigue, and potential allergic reactions related to the infusion of these medications.

AVO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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I am 18 years old or older.

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My cancer has a TP53 mutation or Del(17p) detected.

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My cancer can be measured by blood tests, scans, or physical exams.

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I have not had any treatment for CLL or SLL and now need it according to the 2018 guidelines.

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I have been diagnosed with CLL or SLL.

AVO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The rate of bone marrow minimal residual disease (MRD) negative complete response

Secondary outcome measures

Overall survival

Progression free survival

Rate of Complete Response

+7 more

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199

Headache

Chronic obstructive pulmonary disease

Septic shock

Ischaemic stroke

100%

80%

60%

40%

20%

Study treatment Arm

BSC Alone

Acalabrutinib + BSC

AVO Trial Design

1Treatment groups

Experimental Treatment

Group I: Acalabrutinib/Venetoclax/ObinutuzumabExperimental Treatment3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~1990

Acalabrutinib

2020

Completed Phase 2

~2030

Obinutuzumab

2015

Completed Phase 3

~3250

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Acerta Pharma, LLCOTHER

6 Previous Clinical Trials

260 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,257 Previous Clinical Trials

288,593,714 Total Patients Enrolled

Genentech, Inc.Industry Sponsor

1,539 Previous Clinical Trials

567,617 Total Patients Enrolled

Media Library

Acalabrutinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03580928 — Phase 2

Chronic Lymphocytic Leukemia Research Study Groups: Acalabrutinib/Venetoclax/Obinutuzumab

Chronic Lymphocytic Leukemia Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT03580928 — Phase 2

Acalabrutinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03580928 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are taking part in this investigation?

"This clinical trial requires 72 participants that meet the established criteria to join. Patients can consent from a variety of locations, such as Stamford Hospital/Bennett Cancer Center in Stamford, Connecticut and Dana Farber Cancer Institute in Providence, Rhode island."

Answered by AI

Is this research endeavor currently recruiting participants?

"That is correct. According to clinicaltrials.gov, this medical study initiated on August 7th 2018 and was last modified November 5th 2022; it requires the recruitment of 72 patients from 4 distinct sites."

Answered by AI

To what ailments is Acalabrutinib usually prescribed?

"Acalabrutinib is typically utilized to address small lymphocytic lymphoma, however it can be leveraged for other cases such as lymphoid leukemia, ≥ 1 prior therapy for mantle cell lymphoma, refractory follicular lymphoma."

Answered by AI

To what extent has Acalabrutinib been studied prior to this point?

"Presently, 339 clinical studies are being conducted on the efficacy of Acalabrutinib. Of those ongoing investigations, 43 have advanced to Phase 3 trials; these experiments primarily take place in Edmonton, Alberta with a total of 10710 trial locations across the world."

Answered by AI

Is this experiment unprecedented in its scope?

"According to the most recent data, there are 339 ongoing trials of Acalabrutinib in 55 countries and 1407 cities. The first such trial was conducted by Acerta Pharma BV back in 2014 with 306 participants, which successfully accomplished its Phase 1 & 2 drug approval process. Subsequently 123 more studies have been carried out since then."

Answered by AI

Has Acalabrutinib obtained the necessary regulatory approval by the FDA?

"There is limited clinical evidence demonstrating the safety of Acalabrutinib, so it was rated a 2. As this study is in its Phase 2 stage, there are no data points supporting efficacy yet available."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Acalabrutinib, Venetoclax, and Obinutuzumab as Frontline Treatment for Chronic Lymphocytic Leukaemia: A Single-arm, Open-label, Phase 2 Study

Davids, Matthew S, Benjamin L Lampson, Svitlana Tyekucheva, Zixu Wang, Jessica C Lowney, Samantha Pazienza, Josie Montegaard, et al.. 2021. “Acalabrutinib, Venetoclax, and Obinutuzumab as Frontline Treatment for Chronic Lymphocytic Leukaemia: A Single-arm, Open-label, Phase 2 Study”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(21)00455-1.

The Lancet OncologyJournal

Acalabrutinib, Venetoclax, and Obinutuzumab as Frontline Treatment for Chronic Lymphocytic Leukaemia: A Single-arm, Open-label, Phase 2 Study

clinicaltrials.govStudy

Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL

Matthew S. Davids, MD 2018. "Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03580928.

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