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Kinase Inhibitor

Triple Therapy for Chronic Lymphocytic Leukemia

Phase 1

Recruiting

Led By Stephen E Spurgeon

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of study drug (cycle 1, day 1) to 3, 6, 9, 12 months and 1-3 months after last dose of acalabrutinib up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if giving 3 drugs together helps kill cancer cells in newly-diagnosed CLL patients.

Who is the study for?

This trial is for adults with previously untreated chronic lymphocytic leukemia (CLL). Participants must not have had any prior CLL treatment, be able to swallow pills, and agree to use contraception. They should have a life expectancy over 12 months and meet specific health criteria like adequate organ function. Those with certain other cancers or severe medical conditions are excluded.

What is being tested?

The trial tests the combination of tafasitamab, acalabrutinib, and obinutuzumab in treating CLL. These drugs include monoclonal antibodies that may stop cancer cells from growing and a kinase inhibitor that blocks abnormal proteins in B-cell cancers.

What are the potential side effects?

Potential side effects could include reactions related to the immune system such as infusion reactions, infections due to lowered immunity, liver issues indicated by changes in blood tests, fatigue, digestive problems like nausea or diarrhea, and possibly bleeding complications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of study drug (cycle 1, day 1) to 3, 6, 9, 12 months and 1-3 months after last dose of acalabrutinib up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of study drug (cycle 1, day 1) to 3, 6, 9, 12 months and 1-3 months after last dose of acalabrutinib up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug (cycle 1, day 1) to 3, 6, 9, 12 months and 1-3 months after last dose of acalabrutinib up to 2 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 dose limiting toxicities (DLTs)

Proportion of patients that achieve minimal residual disease (MRD) negativity in peripheral blood

Secondary study objectives

Objective response rate (ORR)

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 (tafasitamab, obinutuzumab, acalabrutinib)Experimental Treatment9 Interventions

See Detailed DescriptionPatients receive obinutuzumab IV over a rate titrated up to 400 mg/hour on days 1, 2, 8, and 15 for cycle 1 then on day 1 for cycles 2-6 and tafasitamab IV over 1.5-2 hours on days 1, 4, 8, 15, and 22 for cycle 2, on days 1, 8, 15, and 22 for cycles 3-4, and on days 1 and 15 for cycles 5-7. Patients also receive acalabrutinib PO BID in each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and CT throughout the trial. Patients may undergo an ECHO at baseline as clinically indicated and may also undergo bone marrow biopsy and/or aspiration at baseline and/or follow-up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acalabrutinib

2020

Completed Phase 2

~2080

Biospecimen Collection

2004

Completed Phase 3

~2030