Description:
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.
Title
- Brief Title: Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies
- 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
Clinical Trial IDs
- ORG STUDY ID:
D8220C00007
- SECONDARY ID:
2018L02939
- NCT ID:
NCT03932331
Conditions
- Phase I: Relapsed or Refractory B-cell Malignancies
- Phase II Cohort A: Relapsed or Refractory Mantle Cell Lymphoma
- Phase II Cohort B: Relapsed or Refractory Chronic Lymphocytic Leukemia
Interventions
Drug | Synonyms | Arms |
---|
Acalabrutinib | | Acalabrutinib |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Acalabrutinib | Experimental | Acalabrutinib will be orally administered until disease progression or unacceptable toxicity. | |
Eligibility 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.
Maximum Eligible Age: | 130 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Phase 1: Number of participants with Adverse Events (AEs) |
Time Frame: | approximately 2 years. |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | 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. |
Safety Issue: | |
Description: | |
Measure: | Phase 2: Number of participants with Adverse Events (AEs) |
Time Frame: | approximately 2 year. |
Safety Issue: | |
Description: | |
Measure: | Phase 2: Plasma concentration of acalabrutinib and its major metabolite (sparse sampling) |
Time Frame: | up to 1 month. |
Safety Issue: | |
Description: | |
Measure: | Phase 2: Progression free survival (PFS) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Phase 2: Duration of Response (DoR) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Phase 2: Time To Response (TTR) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Phase 2: Overall Survival (OS) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Phase 2: Time to Next Treatment (for R/R CLL only) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Phase 2: Minimum Residual Disease Rate (for R/R CLL only) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | AstraZeneca |
Last Updated
August 27, 2021