Recruiting
Phase 3

Ibrutinib

Sponsor:

Janssen Research & Development, LLC

Code:

NCT01804686

Conditions

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Mantle Cell Lymphoma

Follicular Lymphoma

Diffuse Large B-cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ibrutinib

Study Details

Brief summary:

The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.

Conditions

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Mantle Cell Lymphoma

Follicular Lymphoma

Diffuse Large B-cell Lymphoma

Study ID

NCT01804686

Start date

Sep 9, 2013

Status verified date

Jul, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib; or participants must have participated in an ibrutinib randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior ibrutinib treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments; or participants must be currently participating in study PCI-32765LYM1002. At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib
  • Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks
  • Agrees to protocol-defined use of effective contraception
  • Negative blood or urine pregnancy test at screening

Exclusion Criteria:

  • Requires anticoagulation with warfarin or equivalent vitamin K antagonists
  • Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless previously approved by sponsor
  • Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study

Study Design

Enrollment

700 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ibrutinib

Interventions

Ibrutinib

Ibrutinib will be given orally as capsules, once daily continuously, according to the current dosing regimen established in the parent ibrutinib clinical study (560 mg, 420 mg, 280 mg, or 140 mg), at approximately the same time each day.

Primary outcome measure

  • Number of participants affected by an adverse event [ Time Frame: Up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier ]

Central Contacts and Locations

Central contacts

Study Contact

Participate-In-This-Study1@its.jnj.com

Locations

St. Joseph Hospital Center for Cancer Prevention and Treatment

Recruiting

Orange, California, United States, 92868

The Ohio State University- James Cancer Hospital

Recruiting

Columbus, Ohio, United States, 43210

Willamette Valley Cancer Center

Recruiting

Eugene, Oregon, United States, 97401

Avera Medical Group

Recruiting

Sioux Falls, South Dakota, United States, 57105

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • Chronic lymphocytic leukemia
  • Small lymphocytic lymphoma
  • Mantle cell lymphoma
  • Follicular lymphoma
  • Diffuse large B-cell lymphoma
  • PCI-32765
  • Ibrutinib
  • Bruton's tyrosine kinase inhibitor
  • IMBRUVICA
  • JNJ-54179060

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-07-31.