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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + Obinutuzumab + Chlorambucil for Chronic Lymphocytic Leukemia (ElevateTN Trial)

Phase 3

Waitlist Available

Research Sponsored by Acerta Pharma BV

Eligibility Criteria Checklist

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

Must have

Diagnosis of CD20+ CLL meeting specific criteria

Active disease meeting IWCLL 2008 criteria for requiring treatment

Must not have

Receiving anticoagulation with warfarin or equivalent

Known prolymphocytic leukemia or Richter's syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization date until death, withdrawal by subject, lost to follow-up, or by analysis data cut off date on 08feb2019 whichever comes first up to 40 months of follow-up.

Awards & highlights

Pivotal Trial

Approved for 10 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trialevaluates different treatments for chronic lymphocytic leukemia (CLL) to compare efficacy and safety.

Who is the study for?

This trial is for adults with untreated chronic lymphocytic leukemia (CLL). Participants must be over 18, have a certain level of kidney function, and not have had previous systemic treatments for CLL. They should also meet specific health criteria like a particular white blood cell count and organ function. Women who can become pregnant and men who can father children must use effective contraception.

What is being tested?

The study compares the effectiveness of two treatment combinations: obinutuzumab with chlorambucil versus acalabrutinib with obinutuzumab, as well as acalabrutinib alone in treating CLL. It looks at how long patients live without their disease getting worse, overall response rate to treatment, time until next treatment is needed, and overall survival rates.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as infusion reactions or allergies; blood disorders that could affect organs; fatigue; digestive issues which might cause discomfort or changes in bowel movements; increased risk of infections due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with CLL that tests positive for CD20.

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My condition requires treatment according to the IWCLL 2008 guidelines.

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I am a man who can father children and agree to use effective birth control.

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I will not donate sperm during the trial.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

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I am currently taking warfarin or a similar blood thinner.

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I have been diagnosed with prolymphocytic leukemia or Richter's syndrome.

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

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I have uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia.

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I do not have a life-threatening illness or condition right now.

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I need treatment with a strong medication that affects liver enzymes.

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I have taken more than 20 mg of corticosteroids in the week before starting the study drug.

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I have been diagnosed with CNS lymphoma or leukemia.

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I have a known bleeding disorder.

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I have received treatment for chronic lymphocytic leukemia before.

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I have a serious heart condition.

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I need medication for stomach acid.

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I do not have an ongoing serious infection.

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I have a history of HIV infection.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ irc assessments were done from randomization date until disease progression or death or irc discontinuation date on 08feb2019 (as the ia based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~irc assessments were done from randomization date until disease progression or death or irc discontinuation date on 08feb2019 (as the ia based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and irc assessments were done from randomization date until disease progression or death or irc discontinuation date on 08feb2019 (as the ia based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression-free Survival by IRC (Independent Review Committee) Assessment in Arm A Compared to Arm B

Secondary study objectives

IRC-assessed Objective Response Rate (ORR) in Arm A Versus Arm B and Arm A Versus Arm C

Overall Survival (OS) in Arm A Versus Arm B and Arm A Versus Arm C

Progression-free Survival by IRC Assessment Arm A Versus Arm C

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm C - Acalabrutinib MonotherapyExperimental Treatment1 Intervention

Acalabrutinib (ACP-196) will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity.

Group II: Arm B - Acalabrutinib in Combination with ObinutuzumabExperimental Treatment2 Interventions

Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles starting at Cycle 2 Day 1. Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity.

Group III: Arm A - Obinutuzumab in Combination with ChlorambucilActive Control2 Interventions

Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles starting at Cycle 1 Day 1. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acalabrutinib

FDA approved

Obinutuzumab

FDA approved

0 / 20Eligibility criteria met