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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + Venetoclax for Chronic Lymphocytic Leukemia/Lymphoma (MAJIC Trial)

Q: What autoimmune diseases does Acalabrutinib typically help to manage?

Acalabrutinib is frequently used to treat small lymphocytic lymphoma. However, it can also ameliorate symptoms for patients suffering from lymphoid <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, ≥ 1 prior therapy for <a href="https://www.withpower.com/clinical-trials/mantle-cell-lymphoma">mantle cell lymphoma</a>, and refractory <a href="https://www.withpower.com/clinical-trials/follicular-lymphoma">follicular lymphoma</a>.

Q: How can I become a subject in this experiment?

This study is seeking 600 participants with <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a> who are aged 18 or older. Candidates should meet the following criteria: Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)., Participant must be ≥ 18 years at the time of screening., Documented TN <a href="https://www.withpower.com/clinical-trials/cll">CLL</a>/SLL requiring treatment according to iwCLL guidelines 2018 (Hallek et al 2018)., Absolute neutrophil count ≥ 1.0 × 10 9 /L., Platelet counts ≥ 30 × 10 9 /L; in

Q: What other research has been conducted with Acalabrutinib?

Acalabrutinib was first studied in 2012 at CHU de Dijon. As of now, there have been 123 completed trials with 350 more currently underway. The majority of these active studies are taking place in Jacksonville, <a href="https://www.withpower.com/clinical-trials/florida">Florida</a>.

Q: In how many different medical clinics is this medical study being run today?

There are 17 locations currently enrolling patients for this study, with participating clinics located in Jacksonville, Longmont, Buffalo and 14 other cities. To minimize potential travel requirements, it is recommended that you select the clinic nearest to your location.

Q: Could you list some of the potential Acalabrutinib side effects?

Acalabrutinib's safety is well-documented, as this drug has reached Phase 3 in clinical trials.

Q: Is this research study open to elderly participants?

This particular study is looking for clinical trial participants that are aged 18-130. Out of the 3,544 total trials, 655 focus on children and 2889 involve senior citizens.

Q: How many individuals are allowed to participate in this experiment?

That is correct. The clinical trial in question, which was posted on September 12th, 2022 and edited October 3rd, 2022 according to information available on clinicaltrials.gov, is currently recruiting 600 patients from 17 different locations.

Q: Are researchers still looking for participants in this trial?

Yes, this is an active trial according to the information provided on clinicaltrials.gov. The listing for the study says that it was posted on 9/12/2022 and last updated on 10/3/2022. They are looking for 600 patients total from 17 different locations.

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

ECOG performance status of 0 to 2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing

Estimated CrCL of ≥ 30 mL/min calculated by Cockcroft-Gault (using actual body weight) or serum creatinine < 2 × ULN

Timeline

Screening 3 weeks

Treatment Varies

Follow Up date of randomization until pd (assessed up to 6.6 years)

Awards & highlights

MAJIC Trial Summary

This trial compared two different treatment regimens for people with previously untreated CLL or SLL.

Who is the study for?

This trial is for adults with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma who need treatment. Participants must have good bone marrow and liver function, a certain level of kidney function, and be in stable health. They can't join if they've had previous CLL/SLL treatments (except some rituximab), stem cell transplants, significant heart issues within the last 6 months, active infections like HIV or hepatitis B/C, or other conditions that could affect safety.Check my eligibility

What is being tested?

The study compares two drug combinations: Acalabrutinib plus Venetoclax (AV) versus Venetoclax plus Obinutuzumab (VO). It aims to determine which combination works better for patients who haven't been treated before for their blood cancer.See study design

What are the potential side effects?

Possible side effects include diarrhea, headache, fever, fatigue, muscle pain; low blood counts leading to increased infection risk; bleeding problems; allergic reactions; and potential liver dysfunction. Each person's experience may vary.

MAJIC Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My physical ability hasn't worsened in the last 2 weeks.

Select...

My kidney function is good enough for the trial.

Select...

I am 18 years old or older.

Select...

My CLL/SLL requires treatment as per 2018 guidelines.

MAJIC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ date of randomization until pd (assessed up to 6.6 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~date of randomization until pd (assessed up to 6.6 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and date of randomization until pd (assessed up to 6.6 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

Progression-free Survival (PFS)

Secondary outcome measures

Change from baseline in EORTC QLQ-CLL17 scales

Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 scales

Complete Response (CR) rate

+8 more

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199

Headache

Chronic obstructive pulmonary disease

Septic shock

Ischaemic stroke

100%

80%

60%

40%

20%

Study treatment Arm

BSC Alone

Acalabrutinib + BSC

MAJIC Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B: Venetoclax plus Obinutuzumab (VO)Experimental Treatment2 Interventions

Participants will receive Venetoclax orally and Obinutuzumab via IV infusion.

Group II: Arm A: Acalabrutinib plus Venetoclax (AV)Experimental Treatment2 Interventions

Participants will receive acalabrutinib and venetoclax orally.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acalabrutinib

2020

Completed Phase 2

~2050

Obinutuzumab

2015

Completed Phase 3

~3250

Venetoclax

2019

Completed Phase 3

~1990

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,259 Previous Clinical Trials

288,593,300 Total Patients Enrolled

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05057494 — Phase 3

Frequently Asked Questions

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

What autoimmune diseases does Acalabrutinib typically help to manage?

"Acalabrutinib is frequently used to treat small lymphocytic lymphoma. However, it can also ameliorate symptoms for patients suffering from lymphoid leukemia, ≥ 1 prior therapy for mantle cell lymphoma, and refractory follicular lymphoma."

Answered by AI

How can I become a subject in this experiment?

"This study is seeking 600 participants with lymphoma who are aged 18 or older. Candidates should meet the following criteria: Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)., Participant must be ≥ 18 years at the time of screening., Documented TN CLL/SLL requiring treatment according to iwCLL guidelines 2018 (Hallek et al 2018)., Absolute neutrophil count ≥ 1.0 × 10 9 /L., Platelet counts ≥ 30 × 10 9 /L; in"

Answered by AI

What other research has been conducted with Acalabrutinib?

"Acalabrutinib was first studied in 2012 at CHU de Dijon. As of now, there have been 123 completed trials with 350 more currently underway. The majority of these active studies are taking place in Jacksonville, Florida."

Answered by AI

In how many different medical clinics is this medical study being run today?

"There are 17 locations currently enrolling patients for this study, with participating clinics located in Jacksonville, Longmont, Buffalo and 14 other cities. To minimize potential travel requirements, it is recommended that you select the clinic nearest to your location."

Answered by AI

Could you list some of the potential Acalabrutinib side effects?

"Acalabrutinib's safety is well-documented, as this drug has reached Phase 3 in clinical trials."

Answered by AI

Is this research study open to elderly participants?

"This particular study is looking for clinical trial participants that are aged 18-130. Out of the 3,544 total trials, 655 focus on children and 2889 involve senior citizens."

Answered by AI

How many individuals are allowed to participate in this experiment?

"That is correct. The clinical trial in question, which was posted on September 12th, 2022 and edited October 3rd, 2022 according to information available on clinicaltrials.gov, is currently recruiting 600 patients from 17 different locations."

Answered by AI

Are researchers still looking for participants in this trial?

"Yes, this is an active trial according to the information provided on clinicaltrials.gov. The listing for the study says that it was posted on 9/12/2022 and last updated on 10/3/2022. They are looking for 600 patients total from 17 different locations."

Answered by AI

Recent research and studies

Future OncologyJournal

MAJIC: A Phase III Trial of Acalabrutinib + Venetoclax Versus Venetoclax + Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Ryan, Christine E, Matthew S Davids, Richard Hermann, Mina Shahkarami, Juliana Biondo, Sarang Abhyankar, Hasan Alhasani, Jeff P Sharman, Anthony R Mato, and Lindsey E Roeker. 2022. “MAJIC: A Phase III Trial of Acalabrutinib + Venetoclax Versus Venetoclax + Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2022-0456.

clinicaltrials.govStudy

A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

2022. "A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05057494.

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