This study is evaluating the safety, pharmacokinetic profile and efficacy of venetoclax under a once daily dosing schedule in Japanese participants with hematological malignancies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
75 mg/m2 by IV infusion or subcutaneous dosing
Step-up doses of venetoclax to the designated cohort dose
375 mg/m2 on Week 6
NHO Nagoya Medical Center /ID# 129222
Nagoya, Aichi-ken, Japan
Aichi Cancer Center Hospital /ID# 129061
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital /ID# 129278
Number of participants having treatment-emergent adverse events
Collect all adverse events at each visit
Time frame: Approximately 2 years
Time to maximum plasma concentration (Tmax) of venetoclax
Time frame: Approximately 8 days
Maximum plasma concentration (Cmax) of venetoclax
Time frame: Approximately 8 days
Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax
Time frame: Approximately 8 days
Objective Response Rate (Phase 2)
The proportion of participants with response (e.g., partial, complete response) using IWCLL (International Workshop on Chronic Lymphocytic Leukemia) criteria for CLL participants will be computed for all participants with active disease at baseline (in the opinion of the investigator).
Time frame: Approximately 48 months
Objective Response Rate (Phase 1)
The proportion of participants with response (e.g., partial, complete response) using IWG (International Working Group) response criteria for NHL participants, IMWG (International Myeloma Working Group) response criteria for multiple myeloma participants, IWCLL (International Workshop on Chronic Lymphocytic Leukemia) criteria for CLL participants or IWG (International Working Group) criteria for AML participants will be computed for all participants with active disease at baseline (in the opinion of the investigator).
Time frame: Approximately 48 months
Minimal Residual Disease (MRD)
Time frame: Approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
500 mg/m2 Week 10 Day 1 and thereafter
Nagoya, Aichi-ken, Japan
University of Fukui Hospital /ID# 165801
Yoshida-gun, Fukui, Japan
National Hospital Organization Kyushu Cancer Center /ID# 149741
Fukuoka, Fukuoka, Japan
Kyushu University Hospital /ID# 163202
Fukuoka, Fukuoka, Japan
Kobe City Medical Center General Hospital /ID# 170919
Kobe, Hyōgo, Japan
Tohoku University Hospital /ID# 129275
Sendai, Miyagi, Japan
Kindai University Hospital /ID# 169554
Osakasayama-shi, Osaka, Japan
Osaka University Hospital /ID# 169862
Suita-shi, Osaka, Japan
...and 4 more locations
Duration of Response
Duration of response is defined as the number of days from the participant's initial response (e.g., partial, complete response per disease-appropriate response criteria) to the day that disease progression is objectively documented.
Time frame: Approximately 48 months
Time to disease progression
Time to disease progression is defined as the number of days from the date the subject started the study drug to the date of the subject's progression (all events of progression will be included).
Time frame: Approximately 48 months
complete response or remission (CR) rate
CR rate will be defined as the proportion of participants who achieved a complete response or remission (CR) or complete response with incomplete bone marrow recovery or complete remission with incomplete count recovery (CRi) per the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria.
Time frame: Approximately 48 months
Partial response or remission (PR) rate
PR rate will be defined as the proportion of subjects who achieved a nodular PR (nPR) or PR per the 2008 IWCLL criteria.
Time frame: Approximately 48 months
Progression Free Survival (PFS)
Duration of progression-free survival (PFS) will be defined as the number of days from the date of first dose to the date of earliest disease progression or death.
Time frame: Approximately 48 months