Study of Acalabrutinib Alone or in Combination Therapy in Subjects with B-cell Non-Hodgkin Lymphoma

Study identifier:ACE-LY-003

ClinicalTrials.gov identifier:NCT02180711

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects with B-cell Non-Hodgkin Lymphoma

Medical condition

Non Hodgkin Lymphoma

Phase

Phase 1/2

Healthy volunteers

Study drug

acalabrutinib, rituximab (IV), Lenalidomide

Sex

All

Actual Enrollment

113

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 29 Dec 2014

Primary Completion Date: 25 Aug 2023

Estimated Study Completion Date: 29 Dec 2028

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2024 by AcertaPharma

Collaborators

AstraZeneca

Inclusion and exclusion criteria

Inclusion Criteria

• Men and women ≥ 18 years of age.
• Part 1: A confirmed diagnosis of FL Grade 1, 2, or 3a, which has relapsed after, or
been refractory to ≥ 1 prior therapy for FL, or subjects who have not previously
received systemic anticancer therapy for FL., and which requires treatment.
• Part 2: For subject with relapsed or refractory MZL:
Histologically confirmed MZL including splenic, nodal, and extranodal sub-types
a. Subjects with splenic MZL must have an additional measurable lesion, nodal or
extranodal, as described in inclusion criterion #4;
b. Subjects with gastric mucosa-associated lymphoid tissue (MALT) lymphoma
must be Helicobacter pylori (HP)-negative
• Part 3: For subjects with FL: Pathologically confirmed diagnosis of FL Grade 1, 2, or
3a, which has relapsed after, or been refractory to ≥ 1 prior therapy for FL and which
requires treatment per National Cancer Institute or ESMO clinical practice guidelines.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.

Exclusion Criteria

• •A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk
•Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or Qtc >480 msec
•Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
•Breast feeding or pregnant

No locations available

Arms	Assigned Interventions
Experimental: Part 1: acalabrutinib Regimen 1 acalabrutinib Regimen 1 for relapsed, refractory Follicular Lymphoma subjects	-
Experimental: Part 1: acalabrutinib Regimen 2 acalabrutinib Regimen 2 + rituximab for relapsed, refractory, or treatment naive Follicular Lymphoma subjects	-
Experimental: Part 2: acalabrutinib Regimen 1 acalabrutinib Regimen 1 for relapsed, refractory Marginal Zone Lymphoma subjects	-
Experimental: Part 2: acalabrutinib Regimen 2 acalabrutinib Regimen 2 + rituximab for relapsed, refractory Marginal Zone Lymphoma subjects	-
Experimental: Part 3: acalabrutinib Regimen 1 acalabrutinib Regimen + lenalidomide + rituximab for relapsed, refractory Follicular Lymphoma subjects	-

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]