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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Non Hodgkin Lymphoma

In brief

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

Key facts

Study ID

NCT02180711

Run by

Acerta Pharma BV

People needed

113

Starts

2014-12-29

Expected to finish

2028-12-11

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• •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

Where it is running

• Research Site — Tucson, Arizona, United States
• Research Site — Downey, California, United States
• Research Site — Duarte, California, United States
• Research Site — Fountain Valley, California, United States
• Research Site — Santa Monica, California, United States
• Research Site — Coral Gables FL, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — New Orleans, Louisiana, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Morristown, New Jersey, United States
• Research Site — Lake Success, New York, United States
• Research Site — New York, New York, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Greenville, South Carolina, United States
• Research Site — Dallas, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Temple, Texas, United States
• Research Site — Salt Lake City, Utah, United States
• Research Site — Spokane, Washington, United States
• Research Site — Edmonton, Alberta, Canada
• Research Site — London, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.