Non Hodgkin Lymphoma Clinical Trial

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

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

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Full Description

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

View Eligibility Criteria

Eligibility 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;

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

114

Study ID:

NCT02180711

Recruitment Status:

Active, not recruiting

Sponsor:

Acerta Pharma BV

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There are 33 Locations for this study

See Locations Near You

Research Site
Tucson Arizona, 85719, United States
Research Site
Downey California, 90241, United States
Research Site
Duarte California, 91010, United States
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Fountain Valley California, 92708, United States
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Santa Monica California, 90404, United States
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Colorado Springs Colorado, 80909, United States
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Coral Gables FL Florida, 33146, United States
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Chicago Illinois, 60611, United States
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Chicago Illinois, 60612, United States
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Chicago Illinois, 60637, United States
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Louisville Kentucky, 40207, United States
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New Orleans Louisiana, 70112, United States
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Ann Arbor Michigan, 48109, United States
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Morristown New Jersey, 07960, United States
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Hawthorne New York, 10532, United States
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Lake Success New York, 11042, United States
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New York New York, 10021, United States
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Syracuse New York, 13210, United States
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Columbus Ohio, 43210, United States
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Greenville South Carolina, 29615, United States
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Dallas Texas, 75235, United States
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Houston Texas, 77030, United States
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San Antonio Texas, 78217, United States
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Temple Texas, 76508, United States
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Salt Lake City Utah, 84112, United States
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Spokane Washington, 99208, United States
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Waukesha Wisconsin, 53188, United States
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Edmonton Alberta, t6G1Z, Canada
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London Ontario, N6A 5, Canada
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Toronto Ontario, M5G 2, Canada
Research Site
Bologna , 40138, Italy
Research Site
Milano , 20132, Italy
Research Site
Palermo , 90146, Italy

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

114

Study ID:

NCT02180711

Recruitment Status:

Active, not recruiting

Sponsor:


Acerta Pharma BV

How clear is this clinincal trial information?

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