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Acalabrutinib for Mantle Cell Lymphoma

Phase 2
Waitlist Available
Research Sponsored by SCRI Development Innovations, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must meet all of the following criteria in order to be included in this research study: Written informed consent, according to local guidelines, signed by the subject or by a legal guardian prior to the performance of any study-related screening procedures. Men and women ≥18 years-of-age at the time of signature of the informed consent form (ICF). A diagnosis of MCL confirmed by t(11;14) detected by fluorescence in situ hybridization (FISH), conventional cytogenetics, or other molecular evaluation or expression of cyclin D1 confirmed by immunohistochemistry. Subject must have completed induction chemotherapy and plan to and be eligible to receive their first BMT per standard of care. Availability of an archival paraffin-embedded tumor block for MRD testing. The Investigator anticipates that the subject will meet the appropriate lab requirements listed in Screening #2 by Day 100. Patients who received prior therapy with a BTK inhibitor are eligible to enroll.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up safety assessment will be done throughout the study for approximately 2 years
Awards & highlights

Study Summary

This trial will test if Acalabrutinib is an effective maintenance therapy for mantle cell lymphoma patients who have undergone blood or marrow transplant.

Who is the study for?
This trial is for adults with mantle cell lymphoma who've completed chemotherapy and are planning or eligible for a blood/marrow transplant. They should have good organ function, not be pregnant, able to swallow pills, and without serious heart disease or infections. Prior BTK inhibitor therapy is okay.Check my eligibility
What is being tested?
The study tests Acalabrutinib as maintenance therapy after a blood or marrow transplant in mantle cell lymphoma patients. It's to see if this drug can help keep the cancer from coming back post-transplant.See study design
What are the potential side effects?
Acalabrutinib may cause headaches, diarrhea, muscle pain, reduced blood cell counts leading to increased bleeding risk or infection, irregular heartbeat, and potentially serious infections.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~safety assessment will be done throughout the study for approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and safety assessment will be done throughout the study for approximately 2 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 Rate (PFS)
Secondary outcome measures
Conversion rate from Minimal Residual Disease Positive (MRD+) to Minimal Residual Disease Negative (MRD-)
Incidence of Adverse event
Minimal Residual Disease (MRD) correlation with Progression Free Survival (PFS)

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199
2%
Headache
1%
Chronic obstructive pulmonary disease
1%
Septic shock
1%
Ischaemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
BSC Alone
Acalabrutinib + BSC

Trial Design

1Treatment groups
Experimental Treatment
Group I: AcalabrutinibExperimental Treatment1 Intervention
Acalabrutinib will be self-administered orally for up to approximately 2 years post-BMT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2050

Find a Location

Who is running the clinical trial?

Acerta Pharma, LLCOTHER
6 Previous Clinical Trials
317 Total Patients Enrolled
SCRI Development Innovations, LLCLead Sponsor
191 Previous Clinical Trials
13,548 Total Patients Enrolled
Ian Flinn, MD, PhDStudy DirectorSCRI Development Innovations, LLC
5 Previous Clinical Trials
333 Total Patients Enrolled

Media Library

Acalabrutinib Clinical Trial Eligibility Overview. Trial Name: NCT04402138 — Phase 2
Mantle Cell Lymphoma Research Study Groups: Acalabrutinib
Mantle Cell Lymphoma Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT04402138 — Phase 2
Acalabrutinib 2023 Treatment Timeline for Medical Study. Trial Name: NCT04402138 — Phase 2

Frequently Asked Questions

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

Are there any prior explorations into this particular therapeutic trial?

"The medicinal properties of Acalabrutinib have been investigated since 2014, beginning with a 306-patient clinical trial sponsored by Acerta Pharma BV. After the initial research yielded promising results, Phase 1 & 2 drug approval was given in subsequent years. Currently there are 75 active studies concerning this medication being conducted across 507 cities and 47 nations."

Answered by AI

At how many venues is this clinical experiment ongoing?

"Individuals looking to enrol in this trial can do so at Tennessee Oncology in Nashville, HCA Midwest in Kansas City, Colorado Blood Cancer Institute in Denver or any of the additional 4 participating locations."

Answered by AI

What is the upper limit of participants for this medical experiment?

"Affirmative. According to the clinicaltrials.gov database, this research is currently seeking applicants. It was initially announced on August 7th 2020 and most recently updated on May 27th 2022; 50 participants are being sought from 4 locations nationwide."

Answered by AI

Have any other investigations been conducted pertaining to Acalabrutinib?

"Acalabrutinib was first investigated in 2014 by Research Site and has since undergone 24 clinical trials. There are currently 75 active studies, primarily located around Nashville, Tennessee."

Answered by AI

Is enrollment open to participants in this research endeavor?

"Clinicaltrials.gov affirms that this medical trial was posted on August 7th 2020 and is currently in search of participants. The last update to the study occured on May 27th 2022."

Answered by AI

What indications does Acalabrutinib typically address?

"Acalabrutinib is an accepted treatment for mantle cell lymphoma (mcl), small lymphocytic leukemia, and chronic lymphocytic leukemia (cll)."

Answered by AI

Has the FDA given its sanction to Acalabrutinib?

"As this is only a Phase 2 trial, indicating that there is some prior evidence of safety but none for efficacy, our team at Power assessed the security of Acalabrutinib with a score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma
2020. "Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04402138.
~3 spots leftby Apr 2025
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