Trial record 1 of 1 for:
ACE-LY-003
Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02180711 |
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Recruitment Status :
Active, not recruiting
First Posted : July 3, 2014
Last Update Posted : June 28, 2022
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Sponsor:
Acerta Pharma BV
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Acerta Pharma BV
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Brief Summary:
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 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 114 participants |
| Allocation: | N/A |
| 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 : | December 29, 2014 |
| Estimated Primary Completion Date : | August 25, 2023 |
| Estimated Study Completion Date : | August 25, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Acalabrutinib
| Arm | Intervention/treatment |
|---|---|
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Experimental: Part 1: acalabrutinib Regimen 1
acalabrutinib Regimen 1 for relapsed, refractory Follicular Lymphoma subjects
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Drug: acalabrutinib
Other Name: ACP-196 |
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Experimental: Part 1: acalabrutinib Regimen 2
acalabrutinib Regimen 2 + rituximab for relapsed, refractory, or treatment naive Follicular Lymphoma subjects
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Drug: acalabrutinib
Other Name: ACP-196 Drug: rituximab (IV) |
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Experimental: Part 2: acalabrutinib Regimen 1
acalabrutinib Regimen 1 for relapsed, refractory Marginal Zone Lymphoma subjects
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Drug: acalabrutinib
Other Name: ACP-196 |
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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) |
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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 |
Primary Outcome Measures :
- 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
- Subjects with splenic MZL must have an additional measurable lesion, nodal or extranodal, as described in inclusion criterion #4;
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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
Information from the National Library of Medicine
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
Locations
| United States, Arizona | |
| Research Site | |
| Tucson, Arizona, United States, 85719 | |
| United States, California | |
| Research Site | |
| Downey, California, United States, 90241 | |
| Research Site | |
| Duarte, California, United States, 91010 | |
| Research Site | |
| Fountain Valley, California, United States, 92708 | |
| Research Site | |
| Santa Monica, California, United States, 90404 | |
| United States, Colorado | |
| Research Site | |
| Colorado Springs, Colorado, United States, 80909 | |
| United States, Florida | |
| Research Site | |
| Coral Gables FL, Florida, United States, 33146 | |
| United States, Illinois | |
| Research Site | |
| Chicago, Illinois, United States, 60611 | |
| Research Site | |
| Chicago, Illinois, United States, 60612 | |
| Research Site | |
| Chicago, Illinois, United States, 60637 | |
| United States, Kentucky | |
| Research Site | |
| Louisville, Kentucky, United States, 40207 | |
| United States, Louisiana | |
| Research Site | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Michigan | |
| Research Site | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, New Jersey | |
| Research Site | |
| Morristown, New Jersey, United States, 07960 | |
| United States, New York | |
| Research Site | |
| Hawthorne, New York, United States, 10532 | |
| Research Site | |
| Lake Success, New York, United States, 11042 | |
| Research Site | |
| New York, New York, United States, 10021 | |
| Research Site | |
| Syracuse, New York, United States, 13210 | |
| United States, Ohio | |
| Research Site | |
| Columbus, Ohio, United States, 43210 | |
| United States, South Carolina | |
| Research Site | |
| Greenville, South Carolina, United States, 29615 | |
| United States, Texas | |
| Research Site | |
| Dallas, Texas, United States, 75235 | |
| Research Site | |
| Houston, Texas, United States, 77030 | |
| Research Site | |
| San Antonio, Texas, United States, 78217 | |
| Research Site | |
| Temple, Texas, United States, 76508 | |
| United States, Utah | |
| Research Site | |
| Salt Lake City, Utah, United States, 84112 | |
| United States, Washington | |
| Research Site | |
| Spokane, Washington, United States, 99208 | |
| United States, Wisconsin | |
| Research Site | |
| Waukesha, Wisconsin, United States, 53188 | |
| Canada, Alberta | |
| Research Site | |
| Edmonton, Alberta, Canada, t6G1Z2 | |
| Canada, Ontario | |
| Research Site | |
| London, Ontario, Canada, N6A 5W9 | |
| Research Site | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Italy | |
| Research Site | |
| Bologna, Italy, 40138 | |
| Research Site | |
| Milano, Italy, 20132 | |
| Research Site | |
| Palermo, Italy, 90146 | |
Sponsors and Collaborators
Acerta Pharma BV
AstraZeneca
| Responsible Party: | Acerta Pharma BV |
| ClinicalTrials.gov Identifier: | NCT02180711 |
| Other Study ID Numbers: |
ACE-LY-003 |
| First Posted: | July 3, 2014 Key Record Dates |
| Last Update Posted: | June 28, 2022 |
| Last Verified: | June 2022 |
Keywords provided by Acerta Pharma BV:
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Bruton tyrosine kinase inhibitor Btk Follicular Lymphoma FL |
acalabrutinib ACP-196 MZL Marginal Zone Lymphoma |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Rituximab Lenalidomide |
Acalabrutinib Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |