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)
NCT ID: NCT04509622
Last Updated: 2022-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
14 participants
INTERVENTIONAL
2020-10-05
2021-04-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Venetoclax + Low-Dose Cytarabine (LDAC)
Participants will receive venetoclax once daily (QD) on days 1 through 28 plus LDAC QD on days 1 through 10 during the 28-day treatment cycles.
Venetoclax
Tablet; Oral
Cytarabine
Subcutaneous Injection
Interventions
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Venetoclax
Tablet; Oral
Cytarabine
Subcutaneous Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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NHO Nagoya Medical Center /ID# 223671
Nagoya, Aichi-ken, Japan
Aichi Cancer Center Hospital /ID# 223134
Nagoya, Aichi-ken, Japan
University of Fukui Hospital /ID# 223133
Yoshida-gun, Fukui, Japan
Kyushu University Hospital /ID# 223136
Fukuoka, Fukuoka, Japan
Gunmaken Saiseikai Maebashi Hospital /ID# 223301
Maebashi, Gunma, Japan
National Hospital Organization Mito Medical Center /ID# 223392
Higashi Ibaraki-gun, Ibaraki, Japan
Hitachi General Hospital /ID# 223084
Hitachi-shi, Ibaraki, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 223135
Kyoto, Kyoto, Japan
Tohoku University Hospital /ID# 223169
Sendai, Miyagi, Japan
Okayama University Hospital /ID# 222990
Okayama, Okayama-ken, Japan
Osaka City University Hospital /ID# 224269
Osaka, Osaka, Japan
Saitama Medical University International Medical Center /ID# 223575
Hidaka-shi, Saitama, Japan
Juntendo University Hospital /ID# 223086
Bunkyo-ku, Tokyo, Japan
The Jikei University Daisan Hospital /ID# 223418
Komae-shi, Tokyo, Japan
NTT Medical Center Tokyo /ID# 223574
Shinagawa-ku, Tokyo, Japan
Yamagata University Hospital /ID# 223032
Yamagata, Yamagata, Japan
Countries
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Related Links
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clinical study report synopsis
Other Identifiers
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M19-916
Identifier Type: -
Identifier Source: org_study_id
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