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)

Acute Myeloid Leukemia (AML) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04509622
• Other study ID #: M19-916
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia (AML)
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

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

External Links

•   clinical study report synopsis