Acalabrutinib for Chronic Lymphocytic Leukemia

(ASSURE Trial)

Recruiting at 114 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 48 cycles (approximately 48 months)

552 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a global, Phase IIIb, multicenter, open-label, single-arm study to evaluate the safety and efficacy of acalabrutinib 100 mg twice daily (bid) in approximately 540 participants with chronic lymphocytic leukemia (CLL). Participants will be enrolled into 3 following cohorts: treatment-naive (TN), relapsed/refractory (R/R), and prior ibrutinib therapy. For this study, participants in the UK will be enrolled ONLY into the R/R cohort or the prior ibrutinib cohort. Participants in the US will be enrolled ONLY into the TN or R/R cohort. Participants will remain on study intervention until completion of 48 cycles (28 days per cycle), or until study intervention discontinuation due to, for example disease progression, or toxicity, withdrawal of consent, loss to follow-up, death, or study termination by the sponsor whichever occurs first. The duration of the study will be approximately 72 months from the first participant enrolled. This duration includes an estimated 24-month recruitment time and an assumed 48 cycles of study intervention (28 days per cycle); additional study time will be accrued during the Disease Follow up period for those participants remaining on study intervention after completion of 48 cycles prior to the final data cutoff (DCO) (the amount of time will vary by participant).

Research Team

Adel Habib, MD

Principal Investigator

AstraZeneca

Dr. Carsten Niemann, MD

Principal Investigator

Rigshospitalet, Denmark

Eligibility Criteria

This trial is for adults with chronic lymphocytic leukemia (CLL) who are either untreated, have relapsed or are refractory to previous treatments, or have had prior ibrutinib therapy. Participants must show signs of progressive disease and meet specific blood cell count criteria. Pregnant women, individuals with recent malignancies other than CLL, those on certain medications like proton-pump inhibitors or strong CYP3A inhibitors/inducers, and patients with significant heart issues cannot join.

Inclusion Criteria

My blood test shows a specific type of abnormal B-cells.

My blood tests show worsening anemia or low platelets.

I have very large (over 10 cm), growing, or bothersome swollen lymph nodes.

Exclusion Criteria

Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening.

I have had cancer before, but I've been cancer-free for over 2 years, except for minor skin cancers or early prostate cancer.

My kidney function, measured by creatinine clearance, is below 30 mL/min.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive acalabrutinib 100 mg twice daily for up to 48 cycles (each cycle is 28 days)

48 cycles (approximately 48 months)

In-clinic visits every cycle for Cycles 1-6, every 3 cycles for Cycles 7-12, and every 3 cycles with assessments every 6 cycles for Cycles 13-48

Safety Follow-up

Safety follow-up visits occur approximately 30 days from the last dose of study treatment

Approximately 1 month

Disease Follow-up

Participants who continue to derive benefit from treatment after 48 cycles will be followed every 24 weeks until study intervention discontinuation

Varies by participant

Treatment Details

Interventions

• Acalabrutinib

Trial Overview The study tests the safety and effectiveness of acalabrutinib taken twice daily in three groups: treatment-naive patients, those whose CLL has returned or didn't respond to past treatments, and patients previously treated with ibrutinib. The trial will last about six years including a two-year recruitment phase followed by up to four years of treatment cycles.

Participant Groups

Group I: Acalabrutinib Experimental Treatment 1 Intervention

Participants will be enrolled into 3 cohorts. In the treatment-naive cohort, a minimum of 300 participants with treatment-naïve chronic lymphocytic leukemia will be enrolled. In the relapsed/refractory cohort, approximately 200 participants with relapsed/refractory chronic lymphocytic leukemia will be enrolled. In the prior ibrutinib cohort, approximately 40 participants with Prior ibrutinib therapy will be enrolled.

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

Approved in United States as Calquence for:

• Mantle cell lymphoma
• Chronic lymphocytic leukemia
• Small lymphocytic lymphoma

Approved in European Union as Calquence for:

• Chronic lymphocytic leukemia
• Small lymphocytic lymphoma
• Mantle cell lymphoma

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland