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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04509622
Other study ID # M19-916
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 5, 2020
Est. completion date April 15, 2021

Study information

Verified date May 2022
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date April 15, 2021
Est. primary completion date April 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Venetoclax
Tablet; Oral
Cytarabine
Subcutaneous Injection

Locations

Country Name City State
Japan Juntendo University Hospital /ID# 223086 Bunkyo-ku Tokyo
Japan Kyushu University Hospital /ID# 223136 Fukuoka-shi Fukuoka
Japan Saitama Medical University International Medical Center /ID# 223575 Hidaka-shi Saitama
Japan National Hospital Organization Mito Medical Center /ID# 223392 Higashi Ibaraki-gun Ibaraki
Japan Hitachi General Hospital /ID# 223084 Hitachi-shi Ibaraki
Japan The Jikei University Daisan Hospital /ID# 223418 Komae-shi Tokyo
Japan University Hospital Kyoto Prefectural University of Medicine /ID# 223135 Kyoto-shi Kyoto
Japan Gunmaken Saiseikai Maebashi Hospital /ID# 223301 Maebashi-shi Gunma
Japan Aichi Cancer Center Hospital /ID# 223134 Nagoya-shi Aichi
Japan NHO Nagoya Medical Center /ID# 223671 Nagoya-shi Aichi
Japan Okayama University Hospital /ID# 222990 Okayama-shi Okayama
Japan Osaka City University Hospital /ID# 224269 Osaka-shi Osaka
Japan Tohoku University Hospital /ID# 223169 Sendai-shi Miyagi
Japan NTT Medical Center Tokyo /ID# 223574 Shinagawa-ku Tokyo
Japan Yamagata University Hospital /ID# 223032 Yamagata-shi Yamagata
Japan University of Fukui Hospital /ID# 223133 Yoshida-gun Fukui

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events (AEs) An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Up to approximately 9 months after the first participant receives first dose of study drug
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