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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

Age ≥ 18 years

Must not have

Require treatment with proton pump inhibitors

Ongoing or recent infection requiring intravenous antimicrobials at time of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

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.

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.

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 am 18 years old or older.

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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 symptoms due to enlarged lymph nodes or spleen.

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I have symptoms caused by cancer outside the lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need medication for stomach acid.

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I am currently on or recently needed IV antibiotics for an infection.

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I cannot swallow pills well or have serious digestive issues.

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My cancer has spread to my brain or its coverings.

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I have HIV or active hepatitis B or C.

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I have a bleeding disorder or hemophilia.

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I have had cancer before, but it fits the exceptions.

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I am currently on medication that suppresses my immune system.

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I have not received any live vaccines in the last 28 days and do not need any during the study.

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I need treatment with strong medication that affects liver enzymes.

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I have a serious heart condition that is currently affecting me.

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I need warfarin or similar drugs for blood thinning.

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My condition worsened after treatment with a BTK or BCL2 inhibitor.

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I need treatment with specific drugs that affect how my body processes medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Remission Rate

MRD negative complete remission rate

Recommended Phase 2 Dose for acalabrutinib

Secondary study objectives

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

Headache

Septic shock

Ischaemic stroke

Chronic obstructive pulmonary disease

100%

80%

60%

40%

20%

Study treatment Arm

BSC Alone

Acalabrutinib + BSC

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 22Eligibility criteria met