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Bruton's tyrosine kinase (BTK) inhibitor

Venetoclax + Acalabrutinib for Mantle Cell Lymphoma

Phase 2

Waitlist Available

Led By Luhua (Michael) Wang

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years at the time of signing the ICF.

Has not undergone a hysterectomy or bilateral oophorectomy; or

Must not have

a. Subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative PCR result before randomization and must be willing to undergo DNA PCR testing during the study. Those who are HbsAg-positive or hepatitis B PCR positive will be excluded. b. Subjects who are hepatitis C antibody positive will need to have a negative PCR result before randomization. Those who are hepatitis C PCR positive will be excluded.

Known human immunodeficiency virus (HIV) infection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial is studying how well venetoclax and acalabrutinib work to treat mantle cell lymphoma that didn't respond to previous treatment or has come back.

Who is the study for?

This trial is for adults over 18 with mantle cell lymphoma that has returned or didn't respond to past treatments. Participants must have measurable disease, be able to swallow pills, and have normal organ function tests. Pregnant women, those with HIV or active hepatitis, and individuals who've had certain other cancers or major surgery recently can't join.

What is being tested?

The study is testing the combination of two drugs: Venetoclax and Acalabrutinib in patients with relapsed/refractory mantle cell lymphoma. Venetoclax aims to block cancer cells' survival mechanisms while Acalabrutinib may halt their growth by inhibiting necessary enzymes.

What are the potential side effects?

Potential side effects include nausea, vomiting, diarrhea, risk of infection due to low blood counts, fatigue, liver problems indicated by abnormal blood tests (AST/ALT), bleeding issues due to interference with clotting pathways (PT/INR), and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have not had my uterus or both ovaries removed.

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I am able to have children, not pregnant, and will use effective birth control.

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My MCL has returned or didn't respond to at least one treatment and needs more treatment.

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My kidney function is within the required range.

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I can care for myself and have been stable for the last 2 weeks.

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I have had a menstrual period in the last 24 months.

Exclusion Criteria

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

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I am HIV positive.

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I need treatment with specific strong medication inhibitors.

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I do not have any serious infections, including CMV.

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I haven't taken strong immune system suppressants or more than 10mg/day of prednisone in the last 28 days.

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I have a serious brain or spinal cord condition.

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I have severe digestive issues that could affect medication absorption.

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I do not have uncontrolled AIHA or ITP, nor a history of PML.

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I have a bleeding disorder such as von Willebrand's disease or hemophilia.

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My condition did not improve with ibrutinib or other BTK inhibitors.

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I haven't had major surgery in the last 30 days or have fully recovered if I did.

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I had a different cancer, treated successfully over 3 years ago, with no further treatment needed.

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I haven't taken acalabrutinib or any experimental drugs recently.

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I need warfarin or a similar medication for blood thinning.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 response (CR)

Secondary study objectives

Duration of response

Event free survival

Incidence of adverse events

+2 more

Awards & Highlights

No Placebo-Only Group

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

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.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (acalabrutinib, venetoclax)Experimental Treatment2 Interventions

Patients receive acalabrutinib PO BID on days 1-28. Starting cycle 2 day 1, patients also receive venetoclax PO daily. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tyrosine

FDA approved

Venetoclax

FDA approved

0 / 21Eligibility criteria met