Clareo Health | Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Japanese Participants With Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas (iNHL) or Chronic Lymphocytic Leukemia (CLL)
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Japanese Participants With Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas (iNHL) or Chronic Lymphocytic Leukemia (CLL)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants with mature B-cell malignancies of iNHL including follicular lymphoma, small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma, and CLL by World Health Organization classification
Must have been born in Japan and must not have lived outside of Japan for \> 1 year in the 5 years prior to Day 1
Must be able to trace maternal and paternal ancestry of parents and grandparents as Japanese
Must have been previously treated with at least 1 regimen for iNHL or CLL and currently require treatment
Discontinuation of all therapy (including radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of iNHL or CLL ≥ 4 weeks prior to Day 1
Eastern Cooperative Oncology Group performance status of 0 or 1
Required baseline laboratory data (within 4 weeks prior to Day 1)
A negative serum pregnancy test for female participants of childbearing potential
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the individual's disease.
You may not be if
Known histological transformation to an aggressive histology
Known presence of myelodysplastic syndrome
History of iNHL or CLL with central nervous system involvement
Life expectancy \< 120 days as per investigator assessment
History of a nonlymphoid malignancy with the following exceptions:
* the malignancy has been in remission without treatment for ≥ 5 years prior to Day 1, or
* carcinoma in situ of the cervix, or
* adequately treated basal or squamous cell skin cancer or other localized nonmelanoma skin cancer, or
* surgically treated low-grade prostate cancer, or
* ductal carcinoma in situ of the breast treated with lumpectomy alone
On-going drug-induced liver injury, alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension
History or diagnosis of pneumonitis or interstitial lung disease.
On-going inflammatory bowel disease
Pregnancy or breastfeeding
History of prior allogeneic hematopoietic stem cell or solid organ transplantation
Concurrent participation in another therapeutic clinical trial
Prior or on-going clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram finding, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the individual or impair the assessment of study results.
