← Back to Search

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

Must not have

Ongoing or recent infection requiring intravenous antimicrobials at time of screening

Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), and herpes zoster (VZV) at start of treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

I am 18 years old or older.

Select...

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

Select...

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

Select...

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

Select...

I have been diagnosed with CLL or SLL.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently on or recently needed IV antibiotics for an infection.

Select...

I cannot start treatments for pneumocystis, HSV, or VZV before my cancer treatment.

Select...

My cancer has not spread to my brain or transformed into a more aggressive type.

Select...

I have not had major surgery in the last 4 weeks.

Select...

I have a bleeding disorder or hemophilia.

Select...

I need medication for severe heartburn or stomach acid.

Select...

I am not taking strong CYP3A inhibitors or inducers.

Select...

I need treatment with specific drugs that affect how my body processes medications.

Select...

I cannot swallow pills or have a condition that affects how my body absorbs nutrients.

Select...

I have a serious heart condition that is currently active.

Select...

I need warfarin or similar medications for blood thinning.

Select...

I do not have any uncontrolled illnesses or infections.

Select...

I have HIV or active hepatitis B or C.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Overall survival

Progression free survival

Rate of Complete Response

+7 more

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199

Headache

Septic shock

Ischaemic stroke

Chronic obstructive pulmonary disease

100%

80%

60%

40%

20%

Study treatment Arm

BSC Alone

Acalabrutinib + BSC

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2240

Acalabrutinib

2020

Completed Phase 2

~2080

Obinutuzumab

2014

Completed Phase 3

~3470

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

Acerta Pharma, LLCOTHER

6 Previous Clinical Trials

260 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,427 Previous Clinical Trials

289,164,539 Total Patients Enrolled

Genentech, Inc.Industry Sponsor

1,565 Previous Clinical Trials

569,984 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,957 Previous Clinical Trials

41,112,015 Total Patients Enrolled

Dana-Farber Cancer InstituteLead Sponsor

1,113 Previous Clinical Trials

358,809 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,840 Previous Clinical Trials

8,172,548 Total Patients Enrolled

Matthew S. Davids, MD, MMSc4.69 ReviewsPrincipal Investigator - Dana-Farber Cancer Institute

Dana-Farber Cancer Institute

1 Previous Clinical Trials

67 Total Patients Enrolled

5Patient Review

We are incredibly grateful to Dr. Davids. Not only is he an excellent oncologist who always has his finger on the pulse of the latest developments, but he is also so warm, considerate and compassionate. He has repeatedly provided us with sound guidance and support, and we are living better lives because of his care.