Acalabrutinib + BR/VR for Mantle Cell Lymphoma

Phase 1

Waitlist Available

Research Sponsored by Acerta Pharma BV

Eligibility Criteria Checklist

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

Must have

Treatment Naive MCL patients requiring treatment with no exposure to prior therapies

Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Must not have

Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass

Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti-infective treatment within 2 weeks before first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of study drug to within 30 days of last dose of study drug

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug for mantle cell lymphoma in combination with two other drugs.

Who is the study for?

This trial is for adults diagnosed with Mantle Cell Lymphoma (MCL) who have not been treated before. Participants must be in relatively good health, with an ECOG performance status of ≤ 2, and agree to use effective contraception. Pregnant or breastfeeding individuals, those with significant heart disease or gastrointestinal issues that affect drug absorption, or active infections are excluded.

What is being tested?

The study is testing Acalabrutinib combined with either Bendamustine and Rituximab (BR) or Venetoclax and Rituximab (VR). It's a Phase 1b trial where all participants receive the experimental treatment combinations to determine safety and dosage levels.

What are the potential side effects?

Potential side effects may include digestive disturbances due to Bendamustine or Venetoclax; infusion reactions from Rituximab; increased risk of bleeding, bruising, infection from Acalabrutinib; as well as general symptoms like fatigue and nausea.

Eligibility Criteria

Inclusion Criteria

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

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I have mantle cell lymphoma and haven't received any treatment yet.

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I can take care of myself but might not be able to do heavy physical work.

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My diagnosis is Mantle Cell Lymphoma.

Exclusion Criteria

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

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I do not have any major issues with my stomach or intestines that affect how I absorb food or medicine.

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I do not have an ongoing infection that is not improving with treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of study drug to within 30 days of last dose of study drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of study drug to within 30 days of last dose of study drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug to within 30 days of last dose of study drug for reporting.