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Kinase Inhibitor

Dose Level 2 for Chronic Lymphocytic Leukemia

Phase 1

Recruiting

Led By Mayur Narkhede, M.D.

Research Sponsored by Mayur Narkhede

Eligibility Criteria Checklist

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

Must have

On therapy with acalabrutinib for a minimum of 3 months without evidence of progression as per IWCLL 2018 criteria.

Immunophenotype consistent with CLL defined as the predominant population of lymphocytes share both B cell antigens (CD19, CD20 (typically dim expression), or CD23) as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is testing a new combination of drugs (Loncastuximab Tesirine and Aclabrutinib) for treating chronic lymphocytic leukemia. The main goal is to find

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Potential side effects may include reactions where the drug enters the body, changes in blood counts leading to increased infection risk or bleeding problems, liver issues, fatigue, and possible kidney-related complications.

Eligibility Criteria

Inclusion Criteria

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

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

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My leukemia cells show specific markers that indicate CLL.

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My blood or bone marrow test shows remaining cancer.

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My kidneys work well enough (crcl > 30ml/min).

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My blood counts meet the required levels and I haven't used G-CSF in the last week.

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I have CLL that came back or didn't respond to treatment and have had at least one prior therapy before starting acalabrutinib.

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I have been diagnosed with small lymphocytic lymphoma or CLL with high lymphocyte counts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Objective

Secondary outcome measures

Secondary Objective 1

Secondary Objective 2

Secondary Objective 3

+4 more

Trial Design

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

0 / 7Eligibility criteria met

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Who is running the clinical trial?

Mayur NarkhedeLead Sponsor

ADC Therapeutics S.A.Industry Sponsor

28 Previous Clinical Trials

2,273 Total Patients Enrolled

Mayur Narkhede, M.D.Principal InvestigatorUniversity of Alabama at Birmingham

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for participants in this research study?

"Indeed, as stated on clinicaltrials.gov, this trial is currently in the active recruitment phase. It was initially posted on December 18th, 2023 and last updated on December 21st, 2023. The study aims to enroll a total of 24 patients from one location."

Answered by AI

Has the Food and Drug Administration (FDA) granted approval for Dose Level 3?

"Based on our assessment at Power, the safety of Dose Level 3 is rated as 1. This rating is attributed to it being a Phase 1 trial with limited evidence supporting both its safety and effectiveness."

Answered by AI

What is the total number of individuals currently under research in this clinical trial?

"Indeed, the details on clinicaltrials.gov indicate that this trial is currently in search of eligible patients. The trial was initially published on December 18th, 2023 and underwent its latest update on December 21st, 2023. A total of 24 participants will be enrolled at a single study site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Addition of Loncastuximab Tesirine to Acalbrutinib , Chronic Lymphocytic Leukemia

Mayur Narkhede 2023. "Addition of Loncastuximab Tesirine to Acalbrutinib , Chronic Lymphocytic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05971251.