Loncastuximab + Acalabrutinib for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byMayur Narkhede, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Mayur Narkhede

Must be taking: Acalabrutinib

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Pregnancy, CNS involvement, Heart failure, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

Study is a phase I study to determine the maximum tolerated dose of adding Loncastuximab Tesirine to Aclabrutinib in the treatment of chronic lymphocytic leukemia.

Will I have to stop taking my current medications?

The trial requires that participants have been on acalabrutinib for at least 3 months, so you will need to continue taking it. The protocol does not specify if you need to stop other medications, but you cannot be on certain immunosuppressive drugs or high doses of corticosteroids.

Eligibility Criteria

This trial is for people with chronic lymphocytic leukemia (CLL) who have been on Acalabrutinib for at least 3 months without disease progression. Participants must have had prior CLL treatment, measurable residual disease, and adequate kidney and liver function. They should not be using G-CSF within 7 days of joining the study.

Inclusion Criteria

I've been on acalabrutinib for 3+ months with no cancer progression.

My leukemia cells show specific markers that indicate CLL.

My liver functions within normal ranges, or I have Gilbert's Disease.

See 6 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Loncastuximab Tesirine and Acalabrutinib for up to 12 cycles to determine the maximum tolerated dose

36 weeks

12 visits (in-person, every 21 days)

Dose-Limiting Toxicity Evaluation

Evaluation of dose-limiting toxicities over two cycles to determine the maximum tolerated dose

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

Acalabrutinib (Kinase Inhibitor)
Loncastuximab Tesirine (Monoclonal Antibodies)

Trial OverviewThe study aims to find the highest dose of Loncastuximab Tesirine that can be safely added to Acalabrutinib in treating CLL without causing severe side effects. It's an early-phase trial focusing on dosage levels.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Dose level 4:Experimental Treatment1 Intervention

90 µg /kg Loncastuximab Tesirine (for first 2 cycles followed by 75µg/kg for subsequent 10 cycles) + Acalabrutinib 100 mg BID for a total of 12 cycles.

Group II: Dose Level 3Experimental Treatment1 Intervention

75 µg/kg Loncastuximab Tesirine every 21 days + Acalabrutinib 100 mg BID for 12 cycles

Group III: Dose Level 2Experimental Treatment1 Intervention

60 µg/kg Loncastuximab Tesirine every 21 days + Acalabrutinib 100 mg BID for 12 cycles

Group IV: Dose Level 1:Experimental Treatment1 Intervention

45 µg/kg Loncastuximab Tesirine every 21 days + Acalabrutinib 100 mg BID for 12 cycles

Acalabrutinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Calquence for: