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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + BR/VR for Mantle Cell Lymphoma

Phase 1

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

Treatment Naive MCL patients requiring treatment with no exposure to prior therapies

Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of study drug to within 30 days of last dose of study drug

Awards & highlights

Study Summary

This trial is testing a new drug for mantle cell lymphoma in combination with two other drugs.

Who is the study for?

This trial is for adults diagnosed with Mantle Cell Lymphoma (MCL) who have not been treated before. Participants must be in relatively good health, with an ECOG performance status of ≤ 2, and agree to use effective contraception. Pregnant or breastfeeding individuals, those with significant heart disease or gastrointestinal issues that affect drug absorption, or active infections are excluded.Check my eligibility

What is being tested?

The study is testing Acalabrutinib combined with either Bendamustine and Rituximab (BR) or Venetoclax and Rituximab (VR). It's a Phase 1b trial where all participants receive the experimental treatment combinations to determine safety and dosage levels.See study design

What are the potential side effects?

Potential side effects may include digestive disturbances due to Bendamustine or Venetoclax; infusion reactions from Rituximab; increased risk of bleeding, bruising, infection from Acalabrutinib; as well as general symptoms like fatigue and nausea.

Eligibility Criteria

Inclusion Criteria

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

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I have mantle cell lymphoma and haven't received any treatment yet.

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I can take care of myself but might not be able to do heavy physical work.

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My diagnosis is Mantle Cell Lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of study drug to within 30 days of last dose of study drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of study drug to within 30 days of last dose of study drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug to within 30 days of last dose of study drug for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Treatment Emergent Adverse Events (AEs) as assessed by CTCAE v4.03

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 2: Acalabrutinib+VR in TN patientsExperimental Treatment1 Intervention

Part 2: Acalabrutinib in combination with venetoclax and rituximab (VR) in treatment naive patients

Group II: Part 1: Acalabrutinib+BR in TN patientsExperimental Treatment1 Intervention

Part 1: Acalabrutinib in combination with drugs bendamustine and rituximab (BR) in treatment naive patients

Group III: Part 1: Acalabrutinib+BR in RR patientsExperimental Treatment1 Intervention

Part 1: Acalabrutinib in combination with bendamustine and rituximab (BR) in relapse refractory patients

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Acerta Pharma BVLead Sponsor

45 Previous Clinical Trials

5,853 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,259 Previous Clinical Trials

288,593,830 Total Patients Enrolled

Acerta Clinical TrialsStudy Director1-888-292-9613; acertamc@dlss.com

17 Previous Clinical Trials

2,354 Total Patients Enrolled

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02717624 — Phase 1

Mantle Cell Lymphoma Research Study Groups: Part 1: Acalabrutinib+BR in TN patients, Part 1: Acalabrutinib+BR in RR patients, Part 2: Acalabrutinib+VR in TN patients

Mantle Cell Lymphoma Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT02717624 — Phase 1

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02717624 — Phase 1

Frequently Asked Questions

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

Are there facilities executing this research trial in any areas of North America?

"Participants are being recruited from 17 locations, including Columbus, Louisville and Nashville. To reduce the need for travel, it is important to select a site that is close by when registering for this clinical trial."

Answered by AI

Is this a revolutionary exploration into novel treatments?

"Acalabrutinib with BR has been studied since 2014, when Acerta Pharma BV conducted the first trial of 306 participants. After passing Phase 1 & 2 trials successfully, there are currently over 75 active studies being held in 507 cities spanning 47 nations."

Answered by AI

To what illnesses are Acalabrutinib and BR commonly prescribed for?

"Acalabrutinib and BR can both be used to combat Mantle cell lymphoma (MCL), Small Lymphocytic Lymphoma, as well as Chronic lymphocytic leukemia (CLL)."

Answered by AI

Are there any available opportunities to participate in this experiment?

"Unfortunately, this medical trial is not presently enrolling. First posted on April 20th 2016 and last updated October 10th 2022 it has reached its recruitment goals. However, there are 1,795 other studies recruiting new participants at the present time."

Answered by AI

How have prior investigations explored Acalabrutinib in conjunction with BR?

"Currently, 75 clinical trials are being conducted to research the efficacy of Acalabrutinib in combination with BR. 11 of those studies have progressed into Phase 3. While Houston, Texas hosts most investigations for this medication, there is a total 2427 sites conducting similar analyses."

Answered by AI

Has the FDA sanctioned Acalabrutinib and BR as a combined therapeutic option?

"Acalabrutinib in combination with BR has only been tested on a small scale, so the safety rating is 1. This indicates that there are limited data points supporting both efficacy and safety."

Answered by AI

Is there a limit to the number of participants in this medical trial?

"Unfortunately, this trial has ended its recruitment phase. It was posted on April 20th 2016 and lastly updated on October 10th 2022. However, those with lymphoma or mantle-cell have 1720 active clinical trails to explore while Acalabrutinib in combination with BR offers 75 studies actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL

2016. "A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02717624.

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