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BTK Inhibitor

Acalabrutinib + Venetoclax +/- Obinutuzumab for Chronic Lymphocytic Leukemia (AMPLIFY Trial)

Phase 3

Waitlist Available

Led By John Seymour

Research Sponsored by Acerta Pharma BV

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Active disease per IWCLL 2018 criteria that requires treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 years

Awards & highlights

AMPLIFY Trial Summary

This trial will compare the effectiveness of different combinations of drugs to treat previously untreated chronic lymphocytic leukemia.

Who is the study for?

This trial is for adults over 18 with untreated Chronic Lymphocytic Leukemia (CLL) who need treatment. They must be in fairly good health, not pregnant or breastfeeding, and willing to use effective birth control. People can't join if they've had certain serious illnesses recently, like heart disease or stroke, infections like HIV or hepatitis B/C, bleeding disorders, brain lesions called PML, or any prior CLL treatments.Check my eligibility

What is being tested?

The study tests the effectiveness of Acalabrutinib combined with Venetoclax against standard chemoimmunotherapy for CLL. Some participants will also receive Obinutuzumab. The goal is to see which combination works best at treating CLL without previous treatment.See study design

What are the potential side effects?

Possible side effects include allergic reactions to medication components, increased risk of infection due to immune system suppression by drugs like Obinutuzumab and Venetoclax; digestive issues from drug interactions affecting absorption; and potential blood clotting problems.

AMPLIFY 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 and am up and about more than half of my waking hours.

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My condition requires treatment according to the latest guidelines.

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I am 18 years old or older.

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I have been diagnosed with CLL according to the 2018 Hallek criteria.

AMPLIFY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

To evaluate the efficacy of acalabrutinib with venetoclax (Arm A) compared to chemoimmunotherapy fludarabine/cyclophosphamide/rituximab [FCR] or bendamustine/rituximab [BR] (Arm C): PFS

Secondary outcome measures

To evaluate the efficacy of acalabrutinib with venetoclax (Arm A) compared with FCR or BR (Arm C): PFS defined the same as above per investigator assessment.

To evaluate the efficacy of acalabrutinib with venetoclax in combination with obinutuzumab (Arm B) compared with FCR or BR (Arm C): PFS

AMPLIFY Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Acalabrutinib, Venetoclax, ObinutuzumabExperimental Treatment3 Interventions

Acalabrutinib in combination with Venetoclax with Obinutuzumab

Group II: Acalabrutinib, VenetoclaxExperimental Treatment2 Interventions

Acalabrutinib in combination with Venetoclax

Group III: ChemoimmunotherapyActive Control1 Intervention

Chemoimmunotherapy FCR: Fludarabine, Cyclophosphamide and Rituximab BR: Bendamustine and Rituximab

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Acerta Pharma BVLead Sponsor

45 Previous Clinical Trials

4,941 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,257 Previous Clinical Trials

288,592,802 Total Patients Enrolled

John SeymourPrincipal InvestigatorPeter MacCallum Cancer Ctr

Media Library

Acalabrutinib (BTK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03836261 — Phase 3

Chronic Lymphocytic Leukemia Research Study Groups: Acalabrutinib, Venetoclax, Acalabrutinib, Venetoclax, Obinutuzumab, Chemoimmunotherapy

Chronic Lymphocytic Leukemia Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT03836261 — Phase 3

Acalabrutinib (BTK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03836261 — Phase 3

Frequently Asked Questions

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

Are octogenarians eligible for inclusion in this research project?

"This particular trial is for patients that fall in the age bracket of 18 to 130. In contrast, there are 478 trials exclusively for minors and 1612 trials for adults over the age of 65."

Answered by AI

Who meets the eligibility requirements for participating in this research?

"This trial is looking for 780 individuals suffering from cll that are between 18-130 years old. To apply, participants must use highly effective birth control, have an ECOG performance status of 0-2, and be experiencing active disease per IWCLL 2018 criteria."

Answered by AI

How large will this clinical trial be at its biggest?

"Yes, the information on clinicaltrials.gov suggests that this trial is actively looking for candidates. The trial was initially posted on 2/25/2019 and was most recently updated on 11/16/2022. The study is enrolling 780 patients across 1 sites."

Answered by AI

What are the common conditions that Venetoclax is used to treat?

"Venetoclax is a medication used to treat small lymphocytic lymphoma. It can also help patients with various other conditions, such as lymphoid leukemia, mantle cell lymphoma that has not responded well to other treatments, and refractory follicular lymphoma."

Answered by AI

Has the US Food and Drug Administration cleared Venetoclax for public use?

"Venetoclax is considered safe according to our Power team, who rated it a 3. This is because Phase 3 trials have some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

Are there vacancies in this clinical trial for new participants?

"Yes, this study is presently looking for participants. The listing on clinicaltrials.gov shows that the trial was initially posted on February 25th, 2019 and updated as recently as November 16th, 2020."

Answered by AI

What other scientific studies have been done using Venetoclax?

"350 different clinical trials are currently underway to study Venetoclax with 44 of them being in Phase 3. Many of these research programs for Venetoclax are based out of Toronto, Ontario; however, there are 10789 total locations running trials for Venetoclax."

Answered by AI

Recent research and studies

Therapeutic Advances in HematologyJournal

The Evolving Role of Bruton’s Tyrosine Kinase Inhibitors in Chronic Lymphocytic Leukemia

Gordon, Max J., and Alexey V. Danilov. 2021. “The Evolving Role of Bruton’s Tyrosine Kinase Inhibitors in Chronic Lymphocytic Leukemia”. Therapeutic Advances in Hematology. SAGE Publications. doi:10.1177/2040620721989588.

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

Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL