Clinical Trials /

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

NCT03932331

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.

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
  • Chronic Lymphocytic Leukemia
  • Hodgkin Lymphoma
  • Mantle Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma 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 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: Relapsed or Refractory Mantle Cell Lymphoma

Interventions

DrugSynonymsArms
AcalabrutinibAcalabrutinib

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 and other B-cell malignancies. The study is divided into 2 parts: Phase 1 portion and Phase 2 portion.

Trial Arms

NameTypeDescriptionInterventions
AcalabrutinibExperimentalAcalabrutinib will be orally administered until disease progression or unacceptable toxicity.
  • Acalabrutinib

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. Note: Not applicable to CLL subjects.

          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. 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:N/A
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 2 years
Safety Issue:
Description:
Measure:Phase 2: Duration of Response (DoR)
Time Frame:up to 2 years
Safety Issue:
Description:
Measure:Phase 2: Time To Response (TTR)
Time Frame:up to 2 years
Safety Issue:
Description:
Measure:Phase 2: Overall Survival (OS)
Time Frame:up to 2 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:AstraZeneca

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