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)

Last updated: May 3, 2022
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Leukemia (Pediatric)

Leukemia

Treatment

N/A

Clinical Study ID

NCT04509622
M19-916
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Confirmed diagnosis of AML, previously untreated, ineligible for intensive inductionregimen due to age or co-morbidities.
  • Participants who are >= 75 years of age or who are >= 18 to 74 years of age with atleast 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 ejectionfraction <= 50% or chronic stable angina.
  • Diffusion capacity of lung for carbon monoxide (DLCO) <= 65% or forced expiratoryvolume 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 intensivechemotherapy must be reviewed and approved by the AbbVie Therapeutic Area MedicalDirector (TA MD) before study enrollment.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 14
Study Start date:
October 05, 2020
Estimated Completion Date:
April 15, 2021

Connect with a study center

  • Aichi Cancer Center Hospital /ID# 223134

    Nagoya-shi, Aichi 464-8681
    Japan

    Site Not Available

  • NHO Nagoya Medical Center /ID# 223671

    Nagoya-shi, Aichi 460-0001
    Japan

    Site Not Available

  • University of Fukui Hospital /ID# 223133

    Yoshida-gun, Fukui 910-1193
    Japan

    Site Not Available

  • Kyushu University Hospital /ID# 223136

    Fukuoka-shi, Fukuoka 812-8582
    Japan

    Site Not Available

  • Gunmaken Saiseikai Maebashi Hospital /ID# 223301

    Maebashi-shi, Gunma 371-0821
    Japan

    Site Not Available

  • National Hospital Organization Mito Medical Center /ID# 223392

    Higashi Ibaraki-gun, Ibaraki 311-3193
    Japan

    Site Not Available

  • Hitachi General Hospital /ID# 223084

    Hitachi-shi, Ibaraki 317-0077
    Japan

    Site Not Available

  • University Hospital Kyoto Prefectural University of Medicine /ID# 223135

    Kyoto-shi, Kyoto 602-8566
    Japan

    Site Not Available

  • Tohoku University Hospital /ID# 223169

    Sendai-shi, Miyagi 9808574
    Japan

    Site Not Available

  • Okayama University Hospital /ID# 222990

    Okayama-shi, Okayama 700-8558
    Japan

    Site Not Available

  • Osaka City University Hospital /ID# 224269

    Osaka-shi, Osaka 545-8586
    Japan

    Site Not Available

  • Saitama Medical University International Medical Center /ID# 223575

    Hidaka-shi, Saitama 350-1298
    Japan

    Site Not Available

  • Juntendo University Hospital /ID# 223086

    Bunkyo-ku, Tokyo 113-8431
    Japan

    Site Not Available

  • The Jikei University Daisan Hospital /ID# 223418

    Komae-shi, Tokyo 201-8601
    Japan

    Site Not Available

  • NTT Medical Center Tokyo /ID# 223574

    Shinagawa-ku, Tokyo 141-8625
    Japan

    Site Not Available

  • Yamagata University Hospital /ID# 223032

    Yamagata-shi, Yamagata 990-9585
    Japan

    Site Not Available

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