Study of the Bruton's Tyrosine Kinase Inhibitor in Combination With Rituximab in Previously Untreated Subjects With Follicular Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Pharmacyclics
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT01980654
First received: October 24, 2013
Last updated: January 8, 2014
Last verified: January 2014

October 24, 2013
January 8, 2014
December 2013
December 2017   (final data collection date for primary outcome 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: When last subject enrolled has completed 3 years of study follow-up ] [ Designated as safety issue: No ]

Subjects in Arm 1 will have imaging efficacy assessments every 12 weeks for the first 8 assessments and then every 16 weeks thereafter.

Subjects in Arm 2 will have imaging efficacy assessments at the end of 8 weeks and then every 12 weeks thereafter for 8 assessments and then every 16 weeks thereafter.

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: up to 3 years of study treatment ] [ Designated as safety issue: No ]

Subjects in Arm 1 will have imaging efficacy assessments every 12 weeks for the first 8 assessments and then every 16 weeks thereafter.

Subjects in Arm 2 will have imaging efficacy assessments at the end of 8 weeks and then every 12 weeks thereafter for 8 assessments and then every 16 weeks thereafter.

Complete list of historical versions of study NCT01980654 on ClinicalTrials.gov Archive Site
  • To evaluate the efficacy of ibrutinib combined with rituximab in subjects with FL as assessed by the duration of response (DOR). [ Time Frame: When last subject enrolled has completed 3 years of study follow-up ] [ Designated as safety issue: No ]
    DOR is defined as the interval between the date of the first documented response (CR, PR) and the date of the first documented evidence of progressive disease (PD) or death. DOR will be analyzed for the subjects who achieve an overall response during the duration of study.
  • To evaluate the efficacy of ibrutinib combined with rituximab in subjects with FL as assessed by progression free survival (PFS). [ Time Frame: When last subject enrolled has completed 3 years of study follow-up ] [ Designated as safety issue: No ]
    PFS is defined as the time interval between the date of the first dose and the date of the earliest occurrence of PD or death due to any cause, whichever occurs first.
  • To evaluate the efficacy of ibrutinib combined with rituximab in subjects with FL as assessed by overall survival (OS). [ Time Frame: When last subject enrolled has completed 3 years of study follow-up ] [ Designated as safety issue: No ]
    Subjects will be followed for survival information up to three years after the last dose of study treatment, until new treatment or death, whichever occurs first. OS is defined as the duration of time from the date of the first dose to the date of death from any cause.
  • To evaluate the safety and tolerability of ibrutinib combined with rituximab in previously untreated subjects with FL [ Time Frame: When last subject enrolled has completed 3 years of study follow-up ] [ Designated as safety issue: Yes ]
    Frequency, severity, and relatedness of treatment-emergent adverse events (AEs) Frequency of treatment-emergent AEs requiring discontinuation of study drug or dose reductions
  • To evaluate the efficacy of ibrutinib combined with rituximab in subjects with FL as assessed by the duration of response (DOR), progression free survival (PFS), and overall survival (OS) [ Time Frame: up to 3 years of study treatment ] [ Designated as safety issue: No ]

    Subjects in Arm 1 will have imaging efficacy assessments every 12 weeks for the first 8 assessments and then every 16 weeks thereafter.

    Subjects in Arm 2 will have imaging efficacy assessments at the end of 8 weeks and then every 12 weeks thereafter for 8 assessments and then every 16 weeks thereafter.

  • To evaluate the safety and tolerability of ibrutinib combined with rituximab in previously untreated subjects with FL [ Time Frame: Up to 3 years of study treatment ] [ Designated as safety issue: Yes ]

    Frequency, severity, and relatedness of treatment-emergent adverse events (AEs)

    Frequency of treatment-emergent AEs requiring discontinuation of study drug or dose reductions

Not Provided
Not Provided
 
Study of the Bruton's Tyrosine Kinase Inhibitor in Combination With Rituximab in Previously Untreated Subjects With Follicular Lymphoma
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Follicular Lymphoma
  • B-cell Lymphoma
  • Non-Hodgkin's Lymphoma
  • Drug: Ibrutinib
    All subjects will receive 560 mg of Ibrutinib orally.
    Other Name: PCI-32765
  • Drug: rituximab
    All subjects will receive rituximab 375mg/m2 intravenously
    Other Name: Rituxan
  • Experimental: Main Study Arm
    Subjects enrolled into this arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. In addition, subjects will receive rituximab weekly for the first four weeks of study treatment.
    Interventions:
    • Drug: Ibrutinib
    • Drug: rituximab
  • Experimental: Exploratory Study Arm
    Subjects enrolled into this arm will receive ibrutinib continuously as a single agent for eight weeks, then ibrutinib concurrently with rituximab weekly for four weeks. After the rituximab treatment, patients will receive ibrutinib continuously until disease progression or unacceptable toxicity.
    Interventions:
    • Drug: Ibrutinib
    • Drug: rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2017
December 2017   (final data collection date for primary outcome measure)

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 CYP3A4/5 inhibitors.
  9. Known bleeding diathesis or hemophilia
Both
18 Years and older
No
Contact: Vina Truong 855-427-8846 medinfo@pcyc.com
United States
 
NCT01980654
PCYC-1125-CA
No
Pharmacyclics
Pharmacyclics
Not Provided
Study Director: Jutta K. Neuenburg, MD, PhD Pharmacyclics
Pharmacyclics
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP