ASSURE : A Phase 3b, Multicenter, Open-Label, Single-Arm Study of Acalabrutinib (ACP-196) in Subjects With Chronic Lymphocytic Leukemia.

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18-130Age 18-130

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy,Treatment | Blood / Myeloma / LymphomaChronic Lymphocytic Leukaemia,Leukaemia

Trial Overview Read MoreRead more

This phase III trial is evaluating the safety and effectiveness of a targeted therapy in patients with chronic lymphocytic leukaemia.
 

This trial is treating patients with chronic lymphocytic leukaemia.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 3b, Multicenter, Open-Label, Single-Arm Study of Acalabrutinib (ACP-196) in Subjects With Chronic Lymphocytic Leukemia.

Commercial Sponsor

AstraZeneca

Summary

Eligible participants will be enrolled into one of three cohorts. In the treatment-naive (TN) cohort, a minimum of 300 participants with treatment-naive chronic lymphocytic leukemia will be enrolled. In the relapsed/refractory (R/R) cohort, approximately 200 participants with relapsed/refractory chronic lymphocytic leukemia will be enrolled. In the prior Bruton tyrosine kinase inhibitor (BTKi) therapy cohort, up to 70 to 100 participants with Prior BTKi therapy will be enrolled. Across the three cohorts, Acalabrutinib will be administered to participants as one 100 mg capsule, taken orally, twice daily with approximately 240 mL of water.

Recruiting Hospitals Read MoreRead more

Monash Health Haematology Research Unit
Clayton
Ms Micheleine Uhe
Micheleine.Uhe@monashhealth.org
03 9594 4044

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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