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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + Rituximab 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

Serum bilirubin <1.5 mg/dl and creatinine clearance minimum to 50 mL/min per the Cockcroft- Gault formula

Newly diagnosed elderly MCL (age ≥65 years) with no prior therapy under all risk categories

Must not have

Patients who have had a stroke within 6 months.

Active bleeding, history of bleeding diathesis (such as Hemophilia or Von-Willebrand disease), Any history of intracranial bleed or stroke within 6 months of first dose of study drug.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trialstudies acalabrutinib & rituximab to treat mantle cell lymphoma in elderly patients. Acalabrutinib may stop cancer growth & rituximab may kill cancer cells.

Who is the study for?

This trial is for people aged 65 or older with newly diagnosed mantle cell lymphoma, which has specific biological markers. They must be able to swallow pills, have no major health issues that could interfere with the study, and not be on certain medications. Participants need normal organ function and controlled cardiovascular conditions. Pregnant women or those unable to use effective birth control are excluded.

What is being tested?

The trial is testing the combination of acalabrutinib (a drug that blocks enzymes needed for cancer cell growth) and rituximab (an antibody targeting B-cells). It aims to see how well this combo works in treating elderly patients who haven't had any previous treatments for their mantle cell lymphoma.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as infusion reactions from rituximab, bleeding risks due to acalabrutinib's effect on blood clotting, heart rhythm changes, infections due to lowered immunity, liver problems, fatigue, nausea and other gastrointestinal symptoms.

Eligibility Criteria

Inclusion Criteria

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

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My kidney and liver functions are within the required range.

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I am 65 or older with newly diagnosed mantle cell lymphoma and have not received any treatment.

Exclusion Criteria

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

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I have had a stroke in the last 6 months.

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I haven't had any recent bleeding disorders or strokes.

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I do not have significant heart issues or uncontrolled serious conditions.

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I have been taking more than 20 mg of steroids daily for over 2 weeks.

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I need to take warfarin or a similar drug for blood thinning.

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I have severe stomach or bowel problems that affect my ability to absorb medications.

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I have uncontrolled AIHA or ITP.

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I do not have any ongoing serious infections.

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I do not have brain involvement with my lymphoma or a condition called PML.

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I have previously been treated with acalabrutinib or for mantle cell lymphoma.

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I need medication that strongly affects liver enzymes.

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I have or had progressive brain infection (PML).

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 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

Incidence of adverse events (AEs)

Secondary study objectives

Overall response rate

Overall survival (OS)

Progression free survival (PFS)

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: Treatment (acalabrutinib, rituximab)Experimental Treatment2 Interventions

Patients receive acalabrutinib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV over 3-4 hours on days 1, 8, 15, and 22 of cycle 1, and day 1 of cycles 2-12, 14, 18, 20, 22, and 24. Cycles repeats every 28 days for up to 24 months or until complete remission is achieved in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

FDA approved

Tyrosine

FDA approved

0 / 15Eligibility criteria met