Back to resultsA 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)
Primary Purpose
Acute Myeloid Leukemia (AML)
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Venetoclax
Cytarabine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia (AML) focused on measuring Acute Myeloid Leukemia (AML), Cancer, Venetoclax, Venclexta
Eligibility 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.
Sites / Locations
- NHO Nagoya Medical Center /ID# 223671
- Aichi Cancer Center Hospital /ID# 223134
- University of Fukui Hospital /ID# 223133
- Kyushu University Hospital /ID# 223136
- Gunmaken Saiseikai Maebashi Hospital /ID# 223301
- National Hospital Organization Mito Medical Center /ID# 223392
- Hitachi General Hospital /ID# 223084
- University Hospital Kyoto Prefectural University of Medicine /ID# 223135
- Tohoku University Hospital /ID# 223169
- Okayama University Hospital /ID# 222990
- Osaka City University Hospital /ID# 224269
- Saitama Medical University International Medical Center /ID# 223575
- Juntendo University Hospital /ID# 223086
- The Jikei University Daisan Hospital /ID# 223418
- NTT Medical Center Tokyo /ID# 223574
- Yamagata University Hospital /ID# 223032
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Venetoclax + Low-Dose Cytarabine (LDAC)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04509622
Brief Title
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)
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
April 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia (AML)
Keywords
Acute Myeloid Leukemia (AML), Cancer, Venetoclax, Venclexta
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Venetoclax + Low-Dose Cytarabine (LDAC)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
ABT-199, Venclexta
Intervention Description
Tablet; Oral
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Description
Subcutaneous Injection
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs)
Description
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.
Time Frame
Up to approximately 9 months after the first participant receives first dose of study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
NHO Nagoya Medical Center /ID# 223671
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Aichi Cancer Center Hospital /ID# 223134
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
University of Fukui Hospital /ID# 223133
City
Yoshida-gun
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
Kyushu University Hospital /ID# 223136
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Gunmaken Saiseikai Maebashi Hospital /ID# 223301
City
Maebashi-shi
State/Province
Gunma
ZIP/Postal Code
371-0821
Country
Japan
Facility Name
National Hospital Organization Mito Medical Center /ID# 223392
City
Higashi Ibaraki-gun
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Facility Name
Hitachi General Hospital /ID# 223084
City
Hitachi-shi
State/Province
Ibaraki
ZIP/Postal Code
317-0077
Country
Japan
Facility Name
University Hospital Kyoto Prefectural University of Medicine /ID# 223135
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Tohoku University Hospital /ID# 223169
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Okayama University Hospital /ID# 222990
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka City University Hospital /ID# 224269
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Saitama Medical University International Medical Center /ID# 223575
City
Hidaka-shi
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Juntendo University Hospital /ID# 223086
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
The Jikei University Daisan Hospital /ID# 223418
City
Komae-shi
State/Province
Tokyo
ZIP/Postal Code
201-8601
Country
Japan
Facility Name
NTT Medical Center Tokyo /ID# 223574
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Yamagata University Hospital /ID# 223032
City
Yamagata-shi
State/Province
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M19-916&Latitude=&Longitude=&LocationName=#additional-resources-section
Description
clinical study report synopsis
Learn more about this trial
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)
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