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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
Timeline
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.
Awards & highlights
ElevateTN Trial 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.Check my eligibility
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.See study design
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.
ElevateTN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
I am a man who can father children and agree to use effective birth control.
Select...
I will not donate sperm during the trial.
Select...
I can take care of myself and am up and about more than half of my waking hours.
ElevateTN Trial 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival by IRC (Independent Review Committee) Assessment in Arm A Compared to Arm B
Secondary outcome measures
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 moreElevateTN 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
Find a Location
Who is running the clinical trial?
Acerta Pharma BVLead Sponsor
45 Previous Clinical Trials
5,390 Total Patients Enrolled
Acerta Clinical TrialsStudy Director1-888-292-9613; acertamc@dlss.com
17 Previous Clinical Trials
1,891 Total Patients Enrolled
AstraZeneca Clinical Study Information CenterStudy Director1-877-240-9479 information.center@astrazeneca.com
2 Previous Clinical Trials
209 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man who can father children and agree to use effective birth control.I am either over 65 years old or between 18 and 65 with specific conditions.I have been diagnosed with CLL that tests positive for CD20.My condition requires treatment according to the IWCLL 2008 guidelines.I am currently taking warfarin or a similar blood thinner.I have been diagnosed with prolymphocytic leukemia or Richter's syndrome.I have not had major surgery in the last 4 weeks.I have uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia.I have had cancer before, but it's one of the exceptions.I have not had a stroke or brain bleed in the last 6 months.I do not have a life-threatening illness or condition right now.I need treatment with a strong medication that affects liver enzymes.I can visit the clinic for treatments, tests, and scans.I will not donate sperm during the trial.I have taken more than 20 mg of corticosteroids in the week before starting the study drug.I have been diagnosed with CNS lymphoma or leukemia.I have a known bleeding disorder.I have received treatment for chronic lymphocytic leukemia before.I have a serious heart condition.I need medication for stomach acid.I can take care of myself and am up and about more than half of my waking hours.I have not received any live vaccines in the last 4 weeks.I do not have an ongoing serious infection.I have a history of HIV infection.I cannot swallow pills or have a condition that affects how my body absorbs nutrients.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C - Acalabrutinib Monotherapy
- Group 2: Arm A - Obinutuzumab in Combination with Chlorambucil
- Group 3: Arm B - Acalabrutinib in Combination with Obinutuzumab
Awards:
This trial has 4 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical conditions can Acalabrutinib Monotherapy be utilized to ameliorate?
"Acalabrutinib Monotherapy is a valid solution for indolent lymphoma, malt lymphoma, and mantle cell lymphoma that has endured one or more prior treatments."
Answered by AI
Are there any current openings in this experiment?
"This clinical trial is no longer recruiting participants, having been initially posted on the 1st of September 2015 and last updated in October 2019. If you are seeking alternative trials for chronic lymphocytic leukemia, there presently exist 344 active studies while 166 other medical experiments remain open to enrolment with Acalabrutinib Monotherapy as a potential treatment."
Answered by AI
How many individuals have registered to partake in this trial?
"The clinical study is not currently open for enrollment; it was initially publicized on September 1st, 2015 and had its last adjustment made in October 10th, 2019. If you're seeking alternatives, there are presently 344 trials actively recruiting patients with chronic lymphocytic leukemia and 166 studies available that use Acalabrutinib Monotherapy as a possible treatment option."
Answered by AI
What risks might be associated with Acalabrutinib Monotherapy?
"Acalabrutinib Monotherapy achieved a safety score of 3 due to the abundance of clinical data that corroborates its efficacy and multiple rounds of testing confirming its security."
Answered by AI
Are there a plethora of hospitals conducting this experiment in the metropolis?
"As of now, the trial is being held at a total of 52 different sites. Participants are encouraged to select their nearest one out of Roanoke, New Braunfels and Palo Alto or any other location in order to minimise transportation costs."
Answered by AI
Is this exploratory research a pioneering effort?
"Research into the effects of Acalabrutinib Monotherapy has been ongoing since 2012, when it was first examined by Pharmacyclics LLC. After a successful Phase 3 trial involving 232 patients, this medication received drug approval in 2012 and is being further studied today across 1155 cities and 55 countries with 166 active studies."
Answered by AI
Are there any other research studies exploring Acalabrutinib as a stand-alone treatment option?
"Currently, 166 trials are studying the efficacy of Acalabrutinib Monotherapy with 30 in Phase 3. While much of the research is conducted at Pessac, Indiana, there are a total 7478 sites where these studies occur."
Answered by AI
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