Phase 2
N=80
Study of Ibrutinib in Combination With Rituximab in Previously Untreated Subjects With Follicular Lymphoma
Follicular Lymphoma · B-cell Lymphoma · Non-Hodgkin's Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01980654 ↗Enrolled (actual)
80
Serious AEs
25.0%
Results posted
Apr 2019
Primary outcome: Primary: Overall Response Rate (ORR): Proportion of Subjects Achieving the Best Overall Responses of Complete Response (CR) or Partial Response (PR) — 51; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ibrutinib (Drug); rituximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pharmacyclics LLC.
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR): Proportion of Subjects Achieving the Best Overall Responses of Complete Response (CR) or Partial Response (PR) |
51; 15 | — |
| SECONDARY Duration of Response (DOR) |
NA; NA | — |
| SECONDARY Progression Free Survival (PFS) |
41.922; NA | — |
| SECONDARY Overall Survival (OS) |
41.922; NA | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events |
60; 20; 39; 14; 59; 20 | — |
Summary
This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib combined with rituximab in previously untreated subjects with Follicular Lymphoma (FL).
Eligibility Criteria
Key Inclusion criteria
- Histologically documented FL (Grade 1, 2 and 3A)
- Not previously treated with prior anti-cancer therapy for FL
- Stage II, III or IV disease
- At least one measurable lesion ≥ 2 cm in longest diameter by CT and/or MRI scan
- Men and women ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Key Exclusion criteria
- Medically apparent central nervous system lymphoma or leptomeningeal disease
- FL with evidence of large cell transformation
- Any prior history of other hematologic malignancy besides FL or myelodysplasia
- History of other malignancies, except
- Malignancy treated with curative intent and with no known active disease present for ≥5 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician.
- Adequately treated non-melanoma skin cancer or lentigomaligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease.
- Currently active, clinically significant cardiovascular disease or myocardial infarction within 6 months of screening
- Known anaphylaxis or Immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab (Rituxan®)
- Requires anti-coagulation with warfarin or a vitamin K antagonist.
- Requires treatment with strong cytochrome P450 (CYP) 3A inhibitors.
- Known bleeding diathesis or hemophilia
Data sourced from ClinicalTrials.gov (NCT01980654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.