Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma
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ClinicalTrials.gov Identifier: NCT02180711 |
Recruitment Status :
Recruiting
First Posted : July 3, 2014
Last Update Posted : June 19, 2019
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Part 1: To characterize the safety profile of acalabrutinib alone or in combination with rituximab in subjects with R/R FL.
Part 2: To characterize the activity of acalabrutinib alone or in combination with rituximab in subjects with R/R MZL, as measured by ORR.
Part 3: To characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in subjects with R/R FL
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Hodgkin Lymphoma | Drug: acalabrutinib Drug: rituximab (IV) Drug: Lenalidomide | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma |
Actual Study Start Date : | February 2015 |
Estimated Primary Completion Date : | May 2023 |
Estimated Study Completion Date : | May 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Part 1: acalabrutinib Regimen 1
acalabrutinib Regimen 1
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Drug: acalabrutinib
Other Name: ACP-196 |
Experimental: Part 1: acalabrutinib Regimen 2
acalabrutinib Regimen 2 + rituximab for relapsed, refractory, or treatment naive subjects
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Drug: acalabrutinib
Other Name: ACP-196 Drug: rituximab (IV) |
Experimental: Part 2: acalabrutinib Regimen 1
acalabrutinib Regimen 1 for relapsed, refractory Marginal Zone Lymphoma subjects
|
Drug: acalabrutinib
Other Name: ACP-196 |
Experimental: Part 2: acalabrutinib Regimen 2
acalabrutinib Regimen 2 + rituximab for relapsed, refractory Marginal Zone Lymphoma subjects
|
Drug: acalabrutinib
Other Name: ACP-196 Drug: rituximab (IV) |
Experimental: Part 3: acalabrutinib Regimen 1
acalabrutinib Regimen + lenalidomide + rituximab for relapsed, refractory Follicular Lymphoma subjects
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Drug: acalabrutinib
Other Name: ACP-196 Drug: rituximab (IV) Drug: Lenalidomide |
- Number of Participants With Treatment Emergent Adverse Events (AEs) [ Time Frame: From first dose of study drug to within 30 days of last dose of study drug ]Number of participants who had experienced at least one treatment emergent AE

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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Part 2:Histologically confirmed MZL including splenic, nodal, and extranodal sub- types
- Subjects with splenic MZL must have an additional measurable lesion, nodal or extranodal, as described in inclusion criterion #4;
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02180711
Contact: Acerta Call center | 1-888-292-9613 | acertamc@dlss.com |
United States, California | |
City of Hope | Recruiting |
Duarte, California, United States, 91010 | |
Contact: Lacolle Peters 626-218-4632 lapeters@coh.org | |
Principal Investigator: Lihua Budde, MD | |
Innovative Clinical Research | Completed |
Whittier, California, United States, 90603 | |
United States, Illinois | |
Rush University Medical Center | Not yet recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Burge Tonya 312-942-3309 tonya_m_burge@rush.edu | |
Principal Investigator: Parameswaran Venugopal, MD | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Jennifer Madden 773-834-4574 jmadden@medicine.bsd.uchicago.edu | |
Principal Investigator: Sonali Smith, MD | |
United States, Kentucky | |
Norton Cancer Center | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Dana Haycraft dana.haycraft@nortonhealthcare.org | |
Contact: Heather Woolridge heather.woolridge@nortonhealthcare.org | |
Principal Investigator: Don Stevens, MD | |
United States, Michigan | |
University of Michigan, Comprehensive Cancer Center | Active, not recruiting |
Ann Arbor, Michigan, United States, 48109 | |
United States, New York | |
Clinical Research Alliance | Recruiting |
Lake Success, New York, United States, 11042 | |
Contact: Colleen Kats ckats@researchcra.com | |
Contact: Judith Lovecchio jlovecchio@researchcra.com | |
Principal Investigator: Morton Coleman, MD | |
Weill Cornell Medical College | Active, not recruiting |
New York, New York, United States, 10065 | |
United States, Ohio | |
The Ohio State University Medical Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Cynthia Jenkins, RN, BSN 614-366-0855 cynthia.jenkins@osumc.edu | |
Contact: Beth Christian, MD Beth.Christian@osumc.edu | |
Principal Investigator: Beth Christian, MD | |
United States, Texas | |
MD Anderson | Active, not recruiting |
Houston, Texas, United States, 77030 | |
United States, Utah | |
Huntsman Cancer Institute | Recruiting |
Salt Lake City, Utah, United States, 84112 | |
Contact: Anna Frye anna.frye@hci.utah.edu | |
Contact: Lindsay Carpenter lindsay.carpenter@hci.utah.edu | |
Principal Investigator: Deborah Stephens, MD |
Study Director: | Acerta Call center | Acerta Pharma, LLC |
Responsible Party: | Acerta Pharma BV |
ClinicalTrials.gov Identifier: | NCT02180711 History of Changes |
Other Study ID Numbers: |
ACE-LY-003 |
First Posted: | July 3, 2014 Key Record Dates |
Last Update Posted: | June 19, 2019 |
Last Verified: | January 2019 |
Bruton tyrosine kinase inhibitor Btk Follicular Lymphoma FL |
acalabrutinib ACP-196 MZL Marginal Zone Lymphoma |
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Rituximab |
Lenalidomide Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |