Relapsed or Refractory Diffuse Large B-Cell Lymphoma MedDRA version: 21.0 Level: PT Classification code 10012822 Term: Diffuse large B-cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Pharmacyclics LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Pathologically confirmed relapsed/ refractory DLBCL · Must have previously received first line treatment regimen · Must be ineligible for high dose therapy/ stem cell transplantation · Measurable disease sites on CT scan (>1.5 cm in longest dimension) · PT/INR =65 years) yes F.1.3.1 Number of subjects for this age range 46
Exclusion criteria
Exclusion criteria: · Medically apparent central nervous system lymphoma or leptomeningeal disease · History of allogeneic stem-cell (or other organ) transplantation · Any chemotherapy, external beam radiation therapy, or anticancer antibodies within 2 weeks · Radio- or toxin-immunoconjugates within 10 weeks · Concurrent enrollment in another therapeutic investigational study or have previously taken ibrutinib and/or lenalidomide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: • To evaluate the efficacy of ibrutinib in combination with lenalidomide and rituximab by assessing the overall response rate (ORR) in subjects with relapsed or refractory non-GCB DLBCL.;Secondary Objective: Secondary Objectives: • To determine the efficacy of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed or refractory non-GCB DLBCL by assessing the following efficacy parameters: o Complete Response (CR) o Duration of Response (DOR) o Progression Free Survival (PFS) o Overall Survival (OS) • To determine the safety and tolerability of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed or refractory non-GCB DLBCL.;Primary end point(s): The primary efficacy endpoint for Phase 2 is the overall response rate (ORR). The ORR is defined as the rate of subjects who achieve either a PR or CR, according to the revised International Working Group Response Criteria for NHL, as assessed by the investigator (Cheson 2014). The ORR will be calculated for the response-evaluable population of Phase 2. The corresponding 95% 2-sided exact CI will be derived. If the lower bound of the CI around the ORR is greater than or equal to 40%, then the hypothesis that the ORR of the ibrutinib combination treatment is equal to or lower than 40% will be rejected. The ORR will also be calculated for the all-treated population of Phase 2.;Timepoint(s) of evaluation of this end point: The main analysis will be the comparison of response rate within each cohort to the ORR of a historical control of 40%. The null hypothesis that the true ORR is 40% will be tested against a one-sided alternative that the ORR is 60%. The null hypothesis will be rejected, if 27 or more responses are observed in the 49 subjects. This design yields a 1-sided type I error rate of 0.025 and power of 80% when the true ORR is 60%. This statistical design including number of subjects and number of responders follows the stati | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints for Phase 2 of this study are CR, DOR, PFS and OS.;Timepoint(s) of evaluation of this end point: An interim analysis will be performed including approximately 28 evaluable subjects with adequate tumor response assessment. Enrollment in the 20 mg lenalidomide cohort will continue while the interim analysis is performed. Details of the interim analysis and decision rules will be described in the SAP. | — |
Countries
Belgium, Germany, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Pharmacyclics LLC
Outcome results
None listed