Clinical trial NCT04509622: 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)
Official title: An Expanded Access Study for Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction Therapy in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myeloid Leukemia (AML)
Keywords: Acute Myeloid Leukemia (AML)
Cancer
Venetoclax, Venclexta
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-08-12
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 evaluate how safe venetoclax is and assess the adverse events in adult participants with AML.

Venetoclax in combination with low-dose cytarabine (LDAC) is an approved therapy in the United States for patients with newly diagnosed acute myeloid leukemia (AML) aged \> 18 years with a medical condition that prevents the use of intensive chemotherapy. This study provides access to venetoclax in combination with LDAC to participants over 18 years who are ineligible for intensive induction therapy. Around 38 adult participants with diagnosis of AML will be enrolled in approximately 15 sites across Japan.

Participants will receive oral venetoclax tablets once daily on days 1-28 in combination with subcutaneous low-dose cytarabine (LDAC) injections once daily on days 1-10 of the 28-day treatment cycles.

Participants will attend regular visits during the study at a hospital to evaluate safety by medical assessments and blood tests.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* History of prior treatment for AML with the exception of hydroxyurea, allowed through the first cycle of study treatment.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 9 months after the first participant receives first dose of study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: NHO Nagoya Medical Center /ID# 223671
state: Aichi
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital /ID# 223134
state: Aichi
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital /ID# 223133
state: Fukui
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 223136
state: Fukuoka
city: Maebashi-shi
country: Japan
facility: Gunmaken Saiseikai Maebashi Hospital /ID# 223301
state: Gunma
city: Higashi Ibaraki-gun
country: Japan
facility: National Hospital Organization Mito Medical Center /ID# 223392
state: Ibaraki
city: Hitachi-shi
country: Japan
facility: Hitachi General Hospital /ID# 223084
state: Ibaraki
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine /ID# 223135
state: Kyoto
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 223169
state: Miyagi
city: Okayama-shi
country: Japan
facility: Okayama University Hospital /ID# 222990
state: Okayama
city: Osaka-shi
country: Japan
facility: Osaka City University Hospital /ID# 224269
state: Osaka
city: Hidaka-shi
country: Japan
facility: Saitama Medical University International Medical Center /ID# 223575
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 223086
state: Tokyo
city: Komae-shi
country: Japan
facility: The Jikei University Daisan Hospital /ID# 223418
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: NTT Medical Center Tokyo /ID# 223574
state: Tokyo
city: Yamagata-shi
country: Japan
facility: Yamagata University Hospital /ID# 223032
state: Yamagata
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: