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Bruton's Tyrosine Kinase (BTK) Inhibitor

AVO for Mantle Cell Lymphoma

Phase 1 & 2
Recruiting
Led By Austin I Kim, MD
Research Sponsored by Austin I Kim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically determined mantle cell lymphoma with pathologic review at participating institutions
Relapsed or primary refractory after at least one line of therapy including anti-CD20 monoclonal antibody treatment (part A) or; Had no previous anti-lymphoma therapy other than corticosteroids or radiotherapy (parts B and C).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing whether or not the combination of these three drugs can help to treat mantle cell lymphoma, which is a type of cancer that affects the lymph nodes.

Who is the study for?
This trial is for adults with mantle cell lymphoma (MCL) that's come back or didn't respond to treatment, and those who haven't been treated yet. Participants need good organ function, agree to use contraception, and provide bone marrow samples. It's not for those who've had certain prior treatments like BTK inhibitors or have conditions like brain metastases or severe infections.Check my eligibility
What is being tested?
The study tests a combination of three drugs: Acalabrutinib, Venetoclax, and Obinutuzumab in treating MCL. The goal is to see how well these drugs work together in patients who have relapsed/refractory MCL or are untreated.See study design
What are the potential side effects?
Possible side effects include diarrhea, headache, bruising, muscle pain from Acalabrutinib; nausea, low blood counts leading to infection risk from Venetoclax; infusion reactions such as fever and chills from Obinutuzumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lymphoma has been confirmed as mantle cell type by a lab test.
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I have had at least one treatment for my lymphoma that included an anti-CD20 drug (part A) or; I have only been treated with steroids or radiotherapy for my lymphoma (parts B and C).
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I am 18 years old or older.
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I haven't had lymphoma treatment, am eligible for a stem cell transplant, and don't have TP53 mutations.
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I have a tissue sample and blood test results from my initial diagnosis for molecular marker testing.
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My blood test for specific cancer markers was inconclusive.
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I can care for myself but may not be able to do active work.
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I have a tumor or lymph node that is at least 1.5 cm big, or my cancer affects my bone marrow or spleen.
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I have had fever, night sweats, or lost more than 10% of my weight in the last 6 months.
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My blood counts are low due to my illness affecting my organs.
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I have lymphoma, can't have a stem cell transplant, and either have a TP53 mutation or high TP53 expression.
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I have symptoms due to enlarged lymph nodes or spleen.
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I have symptoms caused by cancer outside the lymph nodes.
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I have had previous treatments, including stem cell transplant or CAR T-cell therapy, for my relapsed or refractory condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Complete Remission Rate
MRD negative complete remission rate
Recommended Phase 2 Dose for acalabrutinib
Secondary outcome measures
CR rate after 7 cycles cohort A and C
Complete Remission (CR) rate after 7 cycles in the entire study population
Therapeutic procedure
+13 more

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199
12%
Headache
2%
Respiratory failure
2%
Pneumonia
1%
Hypotension
1%
Acute kidney injury
1%
Pleural effusion
1%
Bacterial sepsis
1%
Mucosal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Acalabrutinib + BSC
BSC Alone

Trial Design

1Treatment groups
Experimental Treatment
Group I: Acalabrutinib, Venetoclax, and ObinutuzumabExperimental Treatment3 Interventions
This study will consist of 3 parts (Parts A, B, and C). In the relapsed/refractory (R/R) MCL setting (Part A), the phase 1 portion consists of a dose finding stage to determine the recommended phase 2 dose (RP2D). It will follow a 3+3 dose finding schema, with a safety pause and evaluation after the first 3 participants have completed through cycle 5, day 1. If there are no dose limiting toxicities (DLTs), an additional 3 participants will be treated and if there are 0 or 1 DLTs seen, the RP2D will have been determined.11 participants will be enrolled in the Part A expansion cohort. Part B will enroll 24 participants with untreated mantle cell lymphoma who are transplant ineligible and/or TP53 mutated. Part C will enroll 12 participants with untreated mantle cell lymphoma who are transplant eligible and TP53 wild type. Each study drug is given according to a different schedule. Each treatment cycle lasts 28 days (4 weeks). Acalabrutinib: Obinutuzumab: Venetoclax:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
FDA approved
Venetoclax
FDA approved
Obinutuzumab
FDA approved

Find a Location

Who is running the clinical trial?

Austin I KimLead Sponsor
AstraZenecaIndustry Sponsor
4,243 Previous Clinical Trials
288,527,719 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,688 Total Patients Enrolled

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04855695 — Phase 1 & 2
Mantle Cell Lymphoma Research Study Groups: Acalabrutinib, Venetoclax, and Obinutuzumab
Mantle Cell Lymphoma Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT04855695 — Phase 1 & 2
Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04855695 — Phase 1 & 2

Frequently Asked Questions

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

Could you describe any other investigations into Acalabrutinib's efficacy?

"Presently, there are 339 active clinical trials for acalabrutinib with 43 of them being in their final phase. Most studies are located within the city limits of Edmonton, Alberta; however, 11 locations worldwide have initiated Acalabrutinib research projects."

Answered by AI

What are the chief goals of this study?

"The primary aim of this 7-month trial is to determine the Complete Remission Rate. Secondary metrics include an examination of overall survival, and a rate of peripheral blood MRD-negativity after seven cycles as measured by clonoSEQ® assay (which uses Next Generation Sequencing). Furthermore, CR will be evaluated radiographically using 2014 Lugano criteria and bone marrow biopsy via histology, immunohistochemistry, and flow cytometry if relevant."

Answered by AI

What is the quota for individuals participating in this experiment?

"Affirmative. Clinicaltrials.gov shows that this medical study is seeking participants, with the original posting being on July 2nd 2021 and a recent update made on August 8th 2022. Up to 53 individuals can be recruited across two trial sites."

Answered by AI

Are there any open positions in this research endeavor?

"Affirmative, the clinical trial registry shows that this study is currently enrolling participants. It was originally made available on July 2nd 2021 and underwent its last update on August 8th 2022. The goal is to enlist 53 patients at two different medical centres."

Answered by AI

To what ailment is Acalabrutinib typically prescribed?

"Acalabrutinib has been approved to manage small lymphocytic lymphoma, leukemia, and mantle cell lymphoma that is unresponsive to prior therapy."

Answered by AI

Is this experiment a groundbreaking endeavor?

"Acalabrutinib has been under investigation since 2014, when a Phase 1 & 2 trial was sponsored by Acerta Pharma BV. This medical intervention is now in 339 active studies located across 1407 cities and 55 nations."

Answered by AI
~12 spots leftby Dec 2024