Overview

This trial is active, not recruiting.

Conditions follicular lymphoma, b-cell lymphoma, non-hodgkin's lymphoma
Treatments ibrutinib, rituximab
Phase phase 2
Targets BTK, CD20
Sponsor Pharmacyclics LLC.
Start date December 2013
End date April 2016
Trial size 80 participants
Trial identifier NCT01980654, PCYC-1125-CA

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 FL.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subjects enrolled into this arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. In addition, subjects will receive rituximab once weekly for four doses for the first four weeks of study treatment.
ibrutinib PCI-32765
All subjects will receive 560 mg of Ibrutinib orally.
rituximab Rituxan
All subjects will receive rituximab 375 mg/m2 intravenously
(Experimental)
Subjects enrolled into this arm will receive ibrutinib continuously as a single agent for the first eight weeks, then ibrutinib concurrently with rituximab once weekly for four doses. After the rituximab treatment, subjects will receive ibrutinib continuously until disease progression or unacceptable toxicity.
ibrutinib PCI-32765
All subjects will receive 560 mg of Ibrutinib orally.
rituximab Rituxan
All subjects will receive rituximab 375 mg/m2 intravenously

Primary Outcomes

Measure
To evaluate the efficacy of ibrutinib when combined with rituximab (determined by the overall response rate [ORR]) in previously untreated subjects with FL.
time frame: 1 year after the last subject enrolled in Arm 1 received the first dose of study drug.

Secondary Outcomes

Measure
To evaluate the efficacy of ibrutinib combined with rituximab in subjects with FL as assessed by the duration of response (DOR).
time frame: 1 year after the last subject enrolled in Arm 1 received the first dose of study drug.
To evaluate the efficacy of ibrutinib combined with rituximab in subjects with FL as assessed by progression free survival (PFS).
time frame: 1 year after the last subject enrolled in Arm 1 received the first dose of study drug.
To evaluate the efficacy of ibrutinib combined with rituximab in subjects with FL as assessed by overall survival (OS).
time frame: 1 year after the last subject enrolled in Arm 1 received the first dose of study drug.
To evaluate the safety and tolerability of ibrutinib combined with rituximab in previously untreated subjects with FL
time frame: 1 year after the last subject enrolled in Arm 1 received the first dose of study drug.

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion criteria: 1. Histologically documented FL (Grade 1, 2 and 3A) 2. Not previously treated with prior anti-cancer therapy for FL 3. Stage II, III or IV disease 4. At least one measurable lesion ≥ 2 cm in longest diameter by CT and/or MRI scan 5. Men and women ≥ 18 years of age 6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 Key Exclusion criteria: 1. Medically apparent central nervous system lymphoma or leptomeningeal disease 2. FL with evidence of large cell transformation 3. Any prior history of other hematologic malignancy besides FL or myelodysplasia 4. History of other malignancies, except 1. 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. 2. Adequately treated non-melanoma skin cancer or lentigomaligna without evidence of disease. 3. Adequately treated carcinoma in situ without evidence of disease. 5. Currently active, clinically significant cardiovascular disease or myocardial infarction within 6 months of screening 6. Known anaphylaxis or IgE-mediated hypersensitivity to murine proteins or to any component of rituximab (Rituxan®) 7. Requires anti-coagulation with warfarin or a vitamin K antagonist. 8. Requires treatment with strong CYP3A inhibitors. 9. Known bleeding diathesis or hemophilia

Additional Information

Official title A Multicenter, Open-Label, Phase 2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab in Previously Untreated Subjects With Follicular Lymphoma
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Pharmacyclics LLC..