NIPH Clinical Trials Search

JRCT ID: jRCT2011200019

Registered date:25/01/2021

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

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedChronic lymphocytic leukemia, Small lymphocytic lymphoma, Mantle cell lymphoma, Follicular lymphoma,
Date of first enrollment12/05/2021
Target sample size700
Countries of recruitmentUnited States,Japan,Germany,Japan,Poland,Japan,Great Britain,Japan,Australia,Japan,Ukraine,Japan,Sweden,Japan,Belgium,Japan,Czech Republic,Japan,Hungary,Japan,Brazil,Japan,France,Japan,Mexico,Japan,Netherlands,Japan,Turkey,Japan,China,Japan,Spain,Japan,Russia,Japan,South Korea,Japan,Ireland,Japan,Colombia,Japan,Canada,Japan,Greece,Japan,Israe,Japan,Italy,Japan,Portugal,Japan,Taiwan,Japan,Argentina,Japan
Study typeInterventional
Intervention(s)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.


Primary OutcomeNumber of participants affected by an adverse event
Secondary OutcomeNumber of participants with change in disease status

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
Include 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
Exclude 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

Related Information


Public contact
Name Medical Information Center
Address 3-5-2 Nishi-kanda, Chiyoda-ku, Tokyo Tokyo Japan 101-0065
Telephone +81-120-183-275
Affiliation Janssen Pharmaceutical K.K.
Scientific contact
Name Ei Fujikawa
Address 3-5-2 Nishi-kanda, Chiyoda-ku, Tokyo Tokyo Japan 101-0065
Telephone +81-120-183-275
Affiliation Janssen Pharmaceutical K.K.