Azacitadine
Drug75 mg/m2 by IV infusion or subcutaneous dosing
NCT Number: NCT02265731
This study is evaluating the safety, pharmacokinetic profile and efficacy of venetoclax under a once daily dosing schedule in Japanese participants with hematological malignancies.
Looking for future studies?
Notify Me20 year and older
All sexes
Interventional
Phase 1 / Phase 2
Aichi Cancer Center Hospital /ID# 129061, Nagoya, Aichi-ken, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Approximately 2 years
Collect all adverse events at each visit
Time frame: Approximately 8 days
Time frame: Approximately 8 days
Time frame: Approximately 8 days
Time frame: Approximately 48 months
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
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 2 years
Time frame: Approximately 48 months
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 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
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
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
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.
AbbVie
Industry
A Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of Venetoclax in Japanese Subjects With Hematological Malignancies
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07101705
Blood Protein Disorders, Cardiovascular Diseases
Wuhan, Hubei, China
View Trial DetailsNCT02790515
Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML)
Memphis, Tennessee, United States
View Trial DetailsNCT02875548
Adenoma, Advanced Solid Tumors
Tucson, Arizona, United States
View Trial DetailsNCT04537715
Adenoma, Advanced Malignancies
Encinitas, California, United States
View Trial Details