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A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study

A Long-term Extension Study of PCI-32765 (Ibrutinib)

Fujikawa Ei

Janssen Pharmaceutical K.K.

3-5-2 Nishi-kanda, Chiyoda-ku, Tokyo

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com

Medical Information Center

Janssen Pharmaceutical K.K.

3-5-2 Nishi-kanda, Chiyoda-ku, Tokyo

+81-120-183-275

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com

Not Recruiting

Mar. 31, 2021

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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

- 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

Both

Chronic lymphocytic leukemia, Small lymphocytic lymphoma, Mantle cell lymphoma, Follicular lymphoma,

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, 140 mg or 70mg), at approximately the same time each day.
For the patients in Japan, the 70 mg capsule should be administrated only when the starting dose is 280 mg or 140 mg, and the dose needs to be reduced to less than 140 mg.

Number of participants affected by an adverse event

Number of participants with change in disease status

+81-11-706-7061

Feb. 16, 2021

Yes

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/transparency. As noted on this site, requests for access to the study data can besubmitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

United States/Germany/Poland/Great Britain/Australia/Ukraine/Sweden/Belgium/Czech Republic/Hungary/Brazil/France/Mexico/Netherlands/Turkey/China/Spain/Russia/South Korea/Ireland/Colombia/Canada/Greece/Israe/Italy/Portugal/Taiwan/Argentina