Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Ability to understand and to sign an informed consent form. The informed consent must be signed before any study specific tests or procedures are done
Chinese, age ≥ 18 years
Patients with histologically confirmed indolent NHL (excluding chronic lymphocytic leukemia) that have relapsed and who are without past or current central nervous system involvement.
Patients must have at least 1 measurable lesion according to the Lugano Classification.
* Patients affected by LPL/WM must have also measurable disease, defined as presence of IgM paraprotein with a minimum IgM level of equal to or greater than 2 times the upper limit of normal (ULN) OR over 10% of lymphoplasmacytic cells in bone marrow.
* Patients with splenic MZL with splenomegaly but no measurable lesion will be considered eligible.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy of at least 12 weeks
Left ventricular ejection fraction (LVEF) ≥ 50%
Prothrombin time (PT) or international normalized ratio (INR) and activated partial thromboplastin time (aPTT) \< 1.5 x the upper limit of normal (ULN)
Adequate bone marrow, liver and renal function
Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment
Women of childbearing potential and men must agree to use highly effective contraception from signing of the informed consent form until at least 1 month after the last study drug administration. The investigator or a designated associate is requested to advise the patient how to achieve highly effective birth control (failure rate of less than 1% per year), e.g. hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence
Proteinuria of CTCAE grade 3 or higher (\> 3.5 g/24 h, measured by urine protein: creatinine ratio on a random urine sample)
Known bleeding diathesis. Any hemorrhage or bleeding event ≥ Grade 3 within 28 days of start of study medication. (NCI-CTCAE Version 4.03)
Uncontrolled diabetes with HbA1c ≥ 8.5%
Ongoing cytomegalovirus (CMV) infection as confirmed by positive polymerase chain reaction (PCR) for CMV
Excluded previous therapies and medications:
Prior treatment with PI3K inhibitors
Anticancer chemotherapy or immunotherapy during the study or within 28 days of first study treatment.
Patients must have recovered from the toxic effects (Grade \<2) of the previous anti-cancer chemotherapy or immunotherapy (with the exception of alopecia)
Biological response modifiers, such as Granulocyte colony stimulating factor (GCSF) within 14 days of first study treatment. G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the principal investigator; however they may not be substituted for a required dose reduction
Use of strong inhibitors of CYP3A4 is prohibited from Day -14 and for the duration of the study
Use of St John's Wort or strong inducers of CYP3A4 is prohibited from Day -14 and for the duration of the study
