Status:
COMPLETED
A Study of Oral Venetoclax Tablet in Combination With Subcutaneous Low-Dose Cytarabine (LDAC) Injection to Assess Adverse Events in Adult Japanese Participants With Acute Myeloid Leukemia (AML)
Lead Sponsor:
AbbVie
Conditions:
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Acute Myeloid Leukemia (AML) is a cancer of the white blood cells which perform many functions, including fighting bacterial infections and defending the body against parasites. This study will evalua...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of AML, previously untreated, ineligible for intensive induction regimen due to age or co-morbidities.
- Participants who are \>= 75 years of age or who are \>= 18 to 74 years of age with at least one of the following co-morbidities:
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3.
- Cardiac history of congestive heart failure requiring treatment or ejection fraction \<= 50% or chronic stable angina.
- Diffusion capacity of lung for carbon monoxide (DLCO) \<= 65% or forced expiratory volume during the first second (FEV1) \<= 65%.
- Adequate renal and hepatic criteria as described in the protocol.
- Other co-morbidities that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the AbbVie Therapeutic Area Medical Director (TA MD) before study enrollment.
Exclusion
- History of prior treatment for AML with the exception of hydroxyurea, allowed through the first cycle of study treatment.
Key Trial Info
Start Date :
October 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04509622
Start Date
October 5 2020
End Date
April 15 2021
Last Update
May 5 2022
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
NHO Nagoya Medical Center /ID# 223671
Nagoya, Aichi-ken, Japan, 460-0001
2
Aichi Cancer Center Hospital /ID# 223134
Nagoya, Aichi-ken, Japan, 464-8681
3
University of Fukui Hospital /ID# 223133
Yoshida-gun, Fukui, Japan, 910-1193
4
Kyushu University Hospital /ID# 223136
Fukuoka, Fukuoka, Japan, 812-8582