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Clinical Trials in Italy / NCT02180711
Active, not recruiting Phase 1/2

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

NCT02180711 · tracked via the Priya Life Science Italy tracker
Sponsor
Acerta Pharma BV
Phase
Phase 1/2
Started
2014-12-29
Last updated
2026-09-28

Condition(s) studied

Non Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

acalabrutinib →rituximab (IV) →Lenalidomide →

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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. * Part 2: For subject with relapsed or refractory MZL: Histologically confirmed MZL including splenic, nodal, and extranodal sub-types 1. Subjects with splenic MZL must have an additional measurable lesion, nodal or extranodal, as described in inclusion criterion #4; 2. 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

Primary outcome measure(s)

  • Part 1: Incidence of Treatment-emergent Adverse Events. — From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 80.7 months (the maximum participant's time on this study).
    Treatment-emergent adverse events were used to characterize the safety profile of acalabrutinib alone or in combination with rituximab in participants with relapsed/refractory follicular lymphoma (R/R FL).
  • Part 2: Investigator Assessed Objective Response Rate (ORR) According to the Lugano Classification for Non-Hodgkin Lymphoma (NHL). — Based on all response assessments since the first dose of study drug until study discontinuation or the initiation of subsequent anticancer therapy, whichever was earlier, up to 65.1 months (the maximum participant's time on this study).
    The objective response rate (ORR) is used to characterize the activity of acalabrutinib alone or in combination with rituximab in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).
  • Part 3: Incidence of Treatment-emergent Adverse Events. — From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 54.3 months (the maximum participant's time on this study).
    Treatment-emergent adverse events were used to characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in participants with relapsed/refractory follicular lymphoma (R/R FL).

Trial sites (29)

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

On this site

📄 Calquence (acalabrutinib) drug profile → 📄 Revlimid (lenalidomide) drug profile →

More Acerta Pharma BV trials in Italy

ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia Active, not recruiting
An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma Active, not recruiting
A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL Active, not recruiting
Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL Active, not recruiting
Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL) Active, not recruiting

Other trials for the same condition

Study of SGR-1505 in Mature B-Cell Neoplasms Recruiting
Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL Recruiting
Bergamo Lymphoid Cancer Registry Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02180711 on ClinicalTrials.gov ↗ ← All trials in Italy