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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
Must not have
Known history of infection with human immunodeficiency virus (HIV)
Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach, or extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with HIV.
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I have a condition that affects how my body absorbs food.
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I have been diagnosed with progressive multifocal leukoencephalopathy.
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I have received treatments for chronic lymphocytic leukemia.
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My cancer has a specific genetic change (del(17p) or TP53 mutation).
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My CLL has transformed into a more aggressive form or has spread to my brain.
Select...
I am not pregnant or breastfeeding.
Select...
I have a known bleeding disorder.
Select...
I am on blood thinners like warfarin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Acalabrutinib
2020
Completed Phase 2
~2080
Venetoclax
2019
Completed Phase 3
~2240
Obinutuzumab
2014
Completed Phase 3
~3470
Find a Location
Who is running the clinical trial?
Acerta Pharma BVLead Sponsor
45 Previous Clinical Trials
4,941 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,425 Previous Clinical Trials
289,139,960 Total Patients Enrolled
John SeymourPrincipal InvestigatorPeter MacCallum Cancer Ctr
Jennifer BrownPrincipal InvestigatorDana Farber Mass General Brigham Cancer Care Inc
1 Previous Clinical Trials
28 Total Patients Enrolled
Barbara EichhorstPrincipal InvestigatorUniversitätsklinikum Köln
Arnon KaterPrincipal InvestigatorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Paolo GhiaPrincipal InvestigatorOSPEDALE S. RAFFAELE - MILANO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with HIV.I can take care of myself and am up and about more than half of my waking hours.I have been diagnosed with progressive multifocal leukoencephalopathy.I have a condition that affects how my body absorbs food.I do not have serious heart problems like recent heart attacks or severe heart failure.I have not received a live virus vaccine in the last 28 days.I have received treatments for chronic lymphocytic leukemia.You have had severe allergic reactions to the study drugs or any of the ingredients in them.I have not had major surgery in the last 30 days.My condition requires treatment according to the latest guidelines.My cancer has a specific genetic change (del(17p) or TP53 mutation).I am 18 years old or older.I have been diagnosed with CLL according to the 2018 Hallek criteria.My CLL has transformed into a more aggressive form or has spread to my brain.I have not had a stroke or brain bleed in the last 6 months.I am not pregnant or breastfeeding.I have a known bleeding disorder.I am on blood thinners like warfarin.
Research Study Groups:
This trial has the following groups:- Group 1: Acalabrutinib, Venetoclax
- Group 2: Acalabrutinib, Venetoclax, Obinutuzumab
- Group 3: Chemoimmunotherapy
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.