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

  • Interventional
  • Recruiting
  • NCT02180711
Eligibility Details Visit Clinicaltrials.gov

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

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 and 4: To characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in subjects with R/R FL or R/R non-GCB DLBCL

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

Gender
All

Age Group
18 Years and up

Accepting 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: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.

         - Part 4: For subjects with non-GCB DLBCL: Pathologically confirmed de novo non- GCB DLBCL based on local IHC using Hans algorithm (Hans 2004) or else subjects must have available archival tissue for central pathology review to be eligible

         - 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

At a Glance

National Government IDNCT02180711

IRB#IRB15-0963

Lead SponsorAcerta Pharma BV

Lead PhysicianSonali Smith

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting