Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies

Phase 1

Active, not recruiting

• Conditions: Phase II Cohort A: Relapsed or Refractory Mantle Cell Lymphoma; Phase II Cohort B: Relapsed or Refractory Chronic Lymphocytic Leukemia; Phase I: Relapsed or Refractory B-cell Malignancies
• Interventions: Drug: Acalabrutinib

• Registration Number: NCT03932331
• Lead Sponsor: AstraZeneca

Brief Summary

This is an open-label, two-part study to assess the safety, tolerability, pharmacokinetics and clinical efficacy of acalabrutinib in Chinese adult subjects with R/R MCL, CLL and other B-cell malignancies. The study is divided into 2 parts: Phase 1 portion and Phase 2 portion.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-29
• Study First Posted: 2019-04-30
• Study Start: 2020-04-29
• Primary Completion: 2022-12-22
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-10
• Study Completion: 2023-12-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acalabrutinib	Acalabrutinib	Acalabrutinib will be orally administered until disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Phase 1: Pharmacokinetics Characterization after multiple doses, CLss/F (Oral clearance at steady stage)	approximately 1 month.
Phase 1: Pharmacokinetics Characterization after single dose, Cmax (Maximum observed plasma concentration)	approximately 1 month.
Phase 1: Pharmacokinetics Characterization after single dose, tmax (Time to maximum concentration)	approximately 1 month.
Phase 1: Pharmacokinetics Characterization after single dose, CL/F (Oral clearance)	approximately 1 month.
Phase 1: Pharmacokinetics Characterization after single dose, λz (Terminal rate constant)	approximately 1 month.
Phase 1: Pharmacokinetics Characterization after single dose, t1/2 (Terminal half life)	approximately 1 month.
Phase 1: Pharmacokinetics Characterization after single dose, MR_Cmax (metabolite-to-parent ratio, Maximum observed plasma concentration)	approximately 1 month.
Phase 1: Pharmacokinetics Characterization after single dose, MR_AUC (metabolite-to-parent ratio, Area under the plasma concentration-time curve (from zero to infinity))	approximately 1 month.
Phase 1: Pharmacokinetics Characterization after multiple doses, AUCτ,ss (Area under the plasma concentration-time curve across the dosing interval at steady state)	approximately 1 month.
Phase 1: Pharmacokinetics Characterization after multiple doses, Cmax,ss (Maximum observed plasma concentration at steady state)	approximately 1 month.
Phase 1: Pharmacokinetics Characterization after multiple doses, Cmin,ss (Minimum observed plasma drug concentration at steady state)	approximately 1 month.
Phase 1: Pharmacokinetics Characterization after multiple doses, tmax,ss (Time to maximum concentration at steady stage)	approximately 1 month.
Phase 1: Pharmacokinetics Characterization after multiple doses, MR_ AUCτ (metabolite-to-parent ratio, Area under the plasma concentration-time curve across the dosing interval)	approximately 1 month.
Phase 1: Pharmacokinetics Characterization after multiple doses, TCP (Temporal change parameter in systemic exposure (also known as: time dependency, temporal parameter change, linearity index); calculated as AUCτ(steady state)/AUC(first dose))	approximately 1 month.
Phase 1: Pharmacokinetics Characterization after multiple doses, Rac(AUC) (Accumulation ratio calculated as AUCτ(steady state)/AUCτ(first dose))	approximately 1 month.
Phase 1: Number of participants with Adverse Events (AEs)	approximately 2 years.
Phase 2: Overall Response Rate (ORR)	up to 3 years
Phase 1: Pharmacokinetics Characterization after single dose, AUC (Area under the plasma concentration-time curve (from zero to infinity) )	approximately 1 month.
Phase 1: Pharmacokinetics Characterization after single dose, AUC0-12 (Area under the plasma concentration-time curve (from zero to 12 hours))	approximately 1 month.
Phase 1: Pharmacokinetics Characterization after single dose, AUC0-t (Area under the plasma concentration-time curve (from zero to the time of the last measurable concentration))	approximately 1 month.
Phase 1: Pharmacokinetics Characterization after single dose, Vz/F (Volume of distribution)	approximately 1 month.
Phase 1: Pharmacokinetics Characterization after multiple doses, Rac(Cmax) (Accumulation ratio calculated as Cmax,ss/Cmax)	approximately 1 month.

Secondary Outcome Measures

Name	Time	Method
Phase 2: Overall Survival (OS)	up to 3 years
Phase 2: Time to Next Treatment (for R/R CLL only)	up to 3 years
Phase 2: Time To Response (TTR)	up to 3 years
Phase 1: Tumor response (number of patients with Complete Response (CR), Partial Response (PR), Stable Diseaase (SD), Progression of Disease (PD))	up to 2 years.
Phase 2: Number of participants with Adverse Events (AEs)	approximately 2 year.
Phase 2: Plasma concentration of acalabrutinib and its major metabolite (sparse sampling)	up to 1 month.
Phase 2: Progression free survival (PFS)	up to 3 years
Phase 2: Duration of Response (DoR)	up to 3 years
Phase 2: Minimum Residual Disease Rate (for R/R CLL only)	up to 3 years

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zhengzhou, China