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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + Lenalidomide + Rituximab for Follicular Lymphoma

Phase 2

Waitlist Available

Led By Paolo Strati

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

Bi-dimensionally measurable disease, with at least one mass lesion >= 2 cm in longest diameter by computed tomography (CT), positron emission tomography (PET)/CT, and/or magnetic resonance imaging (MRI)

Have had no prior systemic treatment for lymphoma

Must not have

Pregnancy, lactation, and investigational agent exclusion criteria

Clinically significant cardiovascular disease exclusion criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of drugs to treat patients with a certain type of lymphoma. The drugs work in different ways to stop the growth of cancer cells.

Who is the study for?

This trial is for adults with CD20 positive stage III-IV, grade 1-3a follicular lymphoma who haven't had prior systemic treatment. They must have measurable disease, meet certain criteria for starting treatment, and be in good physical condition with adequate organ function. Participants need to use effective birth control and cannot be pregnant or breastfeeding.

What is being tested?

The study tests a combination of acalabrutinib (blocks enzymes needed for cancer cell growth), lenalidomide (chemotherapy that kills or stops tumor cells from dividing), and rituximab (monoclonal antibody against cancer cells). It aims to see how well these drugs work together in controlling this type of lymphoma.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as infusion reactions, blood disorders like anemia or clotting problems, liver issues signaled by abnormal enzyme levels, fatigue, infections due to lowered white blood cell counts, and possible digestive disturbances.

Eligibility Criteria

Inclusion Criteria

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

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I have a tumor that is at least 2 cm large, confirmed by imaging tests.

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I have not received any treatment for lymphoma before.

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My liver and kidney tests are within required limits.

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My lymphoma is CD20 positive and is grade 1, 2, or 3a.

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I am registered in the Revlimid REMS program.

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I am a woman who can have children and my pregnancy test was negative.

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I can take care of myself and am up and about more than 50% of my waking hours.

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My condition is in stage III or IV.

Exclusion Criteria

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

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I am not pregnant, breastfeeding, or taking experimental drugs.

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I do not have any major heart conditions.

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I cannot swallow pills easily due to my stomach or intestine issues.

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My condition is a type of aggressive lymphoma.

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I am not taking any medications that are excluded in this trial.

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My condition is Grade 3b Follicular Lymphoma.

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I do not have HIV, active hepatitis B or C, or any uncontrolled infections.

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I cannot switch to H2-receptor antagonists.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Secondary study objectives

Duration of response

Frequency of treatment-emergent AEs requiring study drug discontinuation or dose reduction

Frequency, severity, and relatedness of treatment-emergent adverse events (AEs)

+4 more

Other study objectives

Alteration in immune cell subsets

Cell free circulating deoxyribonucleic acid (DNA)

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

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: Treatment (acalabrutinib, lenalidomide, rituximab)Experimental Treatment3 Interventions

Patients receive acalabrutinib PO BID on days 1-28. Beginning cycle 2, patients receive lenalidomide PO QD on days 1-21 and rituximab IV on days 1, 8, 15, and 22 of cycle 2 and day 1 of subsequent cycles. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

Acalabrutinib

2020

Completed Phase 2

~2080