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)

Study Identifier
M19-916
CT.gov Identifier
NCT04509622
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
Download document(s)
Plain Language Summary
Available Language(s): English, Japanese
Download document(s)

Study Details

Medical Condition
  • Blood Cancer - Acute Myeloid Leukemia (AML)
    • Study Drug
  • Venetoclax
  • Cytarabine
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    NHO Nagoya Medical Center /ID# 223671
    Nagoya, Aichi-ken, Japan, 460-0001
    Status
    Not applicable
    Location
    Aichi Cancer Center Hospital /ID# 223134
    Nagoya, Aichi-ken, Japan, 464-8681
    Status
    Not applicable
    Location
    University of Fukui Hospital /ID# 223133
    Yoshida-gun, Fukui, Japan, 910-1193
    Status
    Not applicable
    Location
    Kyushu University Hospital /ID# 223136
    Fukuoka, Fukuoka, Japan, 812-8582
    Status
    Not applicable
    Location
    Gunmaken Saiseikai Maebashi Hospital /ID# 223301
    Maebashi, Gunma, Japan, 371-0821
    Status
    Not applicable
    Location
    National Hospital Organization Mito Medical Center /ID# 223392
    Higashi Ibaraki-gun, Ibaraki, Japan, 311-3193
    Status
    Not applicable
    Showing {first} - {last} of {total} Results