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Trial record 2 of 16 for:    ABT-199 | Japan

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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ClinicalTrials.gov Identifier: NCT04509622
Recruitment Status : Recruiting
First Posted : August 12, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.


Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia (AML) Drug: Venetoclax Drug: Cytarabine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : May 20, 2021
Estimated Study Completion Date : May 20, 2021


Arm Intervention/treatment
Experimental: Venetoclax + Low-Dose Cytarabine (LDAC)
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.
Drug: Venetoclax
Tablet; Oral
Other Names:
  • ABT-199
  • Venclexta

Drug: Cytarabine
Subcutaneous Injection




Primary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 9 months after the first participant receives first dose of study drug ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04509622


Contacts
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Contact: AbbVie GK Clinical Trial Registration Desk +81-120-587-874 abbvie_jpn_info_clingov@abbvie.com

Locations
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Japan
NHO Nagoya Medical Center /ID# 223671 Not yet recruiting
Nagoya-shi, Aichi, Japan, 460-0001
Aichi Cancer Center Hospital /ID# 223134 Not yet recruiting
Nagoya-shi, Aichi, Japan, 464-8681
University of Fukui Hospital /ID# 223133 Recruiting
Yoshida-gun, Fukui, Japan, 910-1193
Kyushu University Hospital /ID# 223136 Not yet recruiting
Fukuoka-shi, Fukuoka, Japan, 812-8582
Gunmaken Saiseikai Maebashi Hospital /ID# 223301 Not yet recruiting
Maebashi-shi, Gunma, Japan, 371-0821
National Hospital Organization Mito Medical Center /ID# 223392 Not yet recruiting
Higashi Ibaraki-gun, Ibaraki, Japan, 311-3193
Hitachi General Hospital /ID# 223084 Not yet recruiting
Hitachi-shi, Ibaraki, Japan, 317-0077
University Hospital Kyoto Prefectural University of Medicine /ID# 223135 Not yet recruiting
Kyoto-shi, Kyoto, Japan, 602-8566
Tohoku University Hospital /ID# 223169 Not yet recruiting
Sendai-shi, Miyagi, Japan, 980-8574
Okayama University Hospital /ID# 222990 Not yet recruiting
Okayama-shi, Okayama, Japan, 700-8558
Osaka City University Hospital /ID# 224269 Not yet recruiting
Osaka-shi, Osaka, Japan, 545-8586
Saitama Medical University International Medical Center /ID# 223575 Not yet recruiting
Hidaka-shi, Saitama, Japan, 350-1298
Juntendo University Hospital /ID# 223086 Not yet recruiting
Bunkyo-ku, Tokyo, Japan, 113-8431
The Jikei University Daisan Hospital /ID# 223418 Not yet recruiting
Komae-shi, Tokyo, Japan, 201-8601
NTT Medical Center Tokyo /ID# 223574 Recruiting
Shinagawa-ku, Tokyo, Japan, 141-8625
Yamagata University Hospital /ID# 223032 Not yet recruiting
Yamagata-shi, Yamagata, Japan, 990-9585
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04509622    
Other Study ID Numbers: M19-916
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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
Keywords provided by AbbVie:
Acute Myeloid Leukemia (AML)
Cancer
Venetoclax, Venclexta
Additional relevant MeSH terms:
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Venetoclax
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs