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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03932331

Recruitment Status Recruiting

First Posted April 30, 2019

Last update posted April 23, 2021

Study Description

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.

  • Condition or Disease:Phase II Cohort A: Relapsed or Refractory Mantle Cell Lymphoma
    Phase I: Relapsed or Refractory B-cell Malignancies
    Phase II Cohort B: Relapsed or Refractory Chronic Lymphocytic Leukemia
  • Intervention/Treatment: Drug: Acalabrutinib
  • Phase: Phase 1/Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 105 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 1/2 Open Label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies
  • Actual Study Start Date: April 2020
  • Estimated Primary Completion Date: March 2022
  • Estimated Study Completion Date: July 2022
Arms and interventions
Arm Intervention/treatment
Experimental: Acalabrutinib
Acalabrutinib will be orally administered until disease progression or unacceptable toxicity.
Drug: Acalabrutinib
Acalabrutinib 100 mg orally twice daily
Outcome Measures
  • Primary Outcome Measures: 1. Phase 1: Number of participants with Adverse Events (AEs) [ Time Frame: approximately 2 years. ]
  • 2. Phase 2: Overall Response Rate (ORR) [ Time Frame: up to 3 years ]
  • 3. Phase 1: Pharmacokinetics Characterization after single dose, AUC (Area under the plasma concentration-time curve (from zero to infinity) ) [ Time Frame: approximately 1 month. ]
  • 4. Phase 1: Pharmacokinetics Characterization after single dose, AUC0-12 (Area under the plasma concentration-time curve (from zero to 12 hours)) [ Time Frame: approximately 1 month. ]
  • 5. 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)) [ Time Frame: approximately 1 month. ]
  • 6. Phase 1: Pharmacokinetics Characterization after single dose, Cmax (Maximum observed plasma concentration) [ Time Frame: approximately 1 month. ]
  • 7. Phase 1: Pharmacokinetics Characterization after single dose, tmax (Time to maximum concentration) [ Time Frame: approximately 1 month. ]
  • 8. Phase 1: Pharmacokinetics Characterization after single dose, CL/F (Oral clearance) [ Time Frame: approximately 1 month. ]
  • 9. Phase 1: Pharmacokinetics Characterization after single dose, Vz/F (Volume of distribution) [ Time Frame: approximately 1 month. ]
  • 10. Phase 1: Pharmacokinetics Characterization after single dose, λz (Terminal rate constant) [ Time Frame: approximately 1 month. ]
  • 11. Phase 1: Pharmacokinetics Characterization after single dose, t1/2 (Terminal half life) [ Time Frame: approximately 1 month. ]
  • 12. Phase 1: Pharmacokinetics Characterization after single dose, MR_Cmax (metabolite-to-parent ratio, Maximum observed plasma concentration) [ Time Frame: approximately 1 month. ]
  • 13. Phase 1: Pharmacokinetics Characterization after single dose, MR_AUC (metabolite-to-parent ratio, Area under the plasma concentration-time curve (from zero to infinity)) [ Time Frame: approximately 1 month. ]
  • 14. Phase 1: Pharmacokinetics Characterization after multiple doses, AUCτ,ss (Area under the plasma concentration-time curve across the dosing interval at steady state) [ Time Frame: approximately 1 month. ]
  • 15. Phase 1: Pharmacokinetics Characterization after multiple doses, Cmax,ss (Maximum observed plasma concentration at steady state) [ Time Frame: approximately 1 month. ]
  • 16. Phase 1: Pharmacokinetics Characterization after multiple doses, Cmin,ss (Minimum observed plasma drug concentration at steady state) [ Time Frame: approximately 1 month. ]
  • 17. Phase 1: Pharmacokinetics Characterization after multiple doses, tmax,ss (Time to maximum concentration at steady stage) [ Time Frame: approximately 1 month. ]
  • 18. Phase 1: Pharmacokinetics Characterization after multiple doses, CLss/F (Oral clearance at steady stage) [ Time Frame: approximately 1 month. ]
  • 19. Phase 1: Pharmacokinetics Characterization after multiple doses, MR_ AUCτ (metabolite-to-parent ratio, Area under the plasma concentration-time curve across the dosing interval) [ Time Frame: approximately 1 month. ]
  • 20. 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)) [ Time Frame: approximately 1 month. ]
  • 21. Phase 1: Pharmacokinetics Characterization after multiple doses, Rac(AUC) (Accumulation ratio calculated as AUCτ(steady state)/AUCτ(first dose)) [ Time Frame: approximately 1 month. ]
  • 22. Phase 1: Pharmacokinetics Characterization after multiple doses, Rac(Cmax) (Accumulation ratio calculated as Cmax,ss/Cmax) [ Time Frame: approximately 1 month. ]
  • Secondary Outcome Measures: 1. Phase 1: Tumor response (number of patients with Complete Response (CR), Partial Response (PR), Stable Diseaase (SD), Progression of Disease (PD)) [ Time Frame: up to 2 years. ]
  • 2. Phase 2: Number of participants with Adverse Events (AEs) [ Time Frame: approximately 2 year. ]
  • 3. Phase 2: Plasma concentration of acalabrutinib and its major metabolite (sparse sampling) [ Time Frame: up to 1 month. ]
  • 4. Phase 2: Progression free survival (PFS) [ Time Frame: up to 3 years ]
  • 5. Phase 2: Duration of Response (DoR) [ Time Frame: up to 3 years ]
  • 6. Phase 2: Time To Response (TTR) [ Time Frame: up to 3 years ]
  • 7. Phase 2: Overall Survival (OS) [ Time Frame: up to 3 years ]
  • 8. Phase 2: Time to Next Treatment (for R/R CLL only) [ Time Frame: up to 3 years ]
  • 9. Phase 2: Minimum Residual Disease Rate (for R/R CLL only) [ Time Frame: up to 3 years ]
Eligibility Criteria
  • Ages Eligible for Study: 18 to 130 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria

1. Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the informed consent form (ICF) and in this
protocol.

2. Chinese subjects at least 18 years of age at the time of study entry.

3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2

4. Adequate hematological and organ function.

5. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid
malignancy.

6. Pathologically confirmed MCL, with documentation of chromosome translocation t(11;14)
(q13;q32) and/or overexpression of cyclin D1 in association with other relevant
markers (eg, CD5, CD19, CD20, PAX5). Disease had relapsed after or been refractory to
previous treatment.

7. Diagnosis of CLL that meets published diagnostic criteria. Must have received ≥ 1
prior systemic therapies for CLL.

8. Active disease per iwCLL 2018 criteria that requires treatment. (CLL only)

9. Other relapsed/refractory B-cell malignancies without stand of care (phase 1 only).

Exclusion criteria

1. Prior malignancy, except for adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer, or other cancer from which the subject had been
disease free for ≥2 years or which would not have limited survival to <2 years. 2. Significant cardiovascular disease. 3. Known central nervous system involvement of lymphoma/leukemia or leptomeningeal disease. 4. Known history of HIV, serologic status reflecting active hepatitis B or C infection. 5. Major surgery within 4 weeks before first dose of study drugs. 6. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura. 7. Required or received anticoagulation with warfarin or equivalent vitamin K antagonist (eg, phenprocoumon). 8. Prior exposure to a BCR or BCL-2 inhibitor. 9. Use of a strong inhibitor or inducer of CYP3A. 10. Breastfeeding or pregnant.

Contacts and Locations
Contacts

Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
Show 27 Study Locations
Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator: Jun Zhu, Prof Beijing Cancer Hospital

More Information
  • Responsible Party: AstraZeneca
  • ClinicalTrials.gov Identifier: NCT03932331 History of Changes
  • Other Study ID Numbers: D8220C00007, 2018L02939
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: April 23, 2021
  • Last Verified: April 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP)
  • Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
  • Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
  • URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Lymphoma
    Leukemia
    Neoplasms
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell
    Lymphoma, Mantle-Cell