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Acute Myeloid Leukemia (AML)Phase 3NCT04509622

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)

A Phase 3 study testing Venetoclax and Cytarabine in people with Acute Myeloid Leukemia (AML), run by AbbVie at 16 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia (AML)
What is being tested?
Venetoclax and Cytarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
16 sitesJapan
Study dates
5 Oct 2020to 15 Apr 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Japan16 sites

  • Juntendo University Hospital /ID# 223086

    Bunkyo-ku, Tokyo, 113-8431

  • Kyushu University Hospital /ID# 223136

    Fukuoka, Fukuoka, 812-8582

  • Saitama Medical University International Medical Center /ID# 223575

    Hidaka-shi, Saitama, 350-1298

  • National Hospital Organization Mito Medical Center /ID# 223392

    Higashi Ibaraki-gun, Ibaraki, 311-3193

  • Hitachi General Hospital /ID# 223084

    Hitachi-shi, Ibaraki, 317-0077

  • The Jikei University Daisan Hospital /ID# 223418

    Komae-shi, Tokyo, 201-8601

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

    Kyoto, Kyoto, 602-8566

  • Gunmaken Saiseikai Maebashi Hospital /ID# 223301

    Maebashi, Gunma, 371-0821

  • NHO Nagoya Medical Center /ID# 223671

    Nagoya, Aichi-ken, 460-0001

  • Aichi Cancer Center Hospital /ID# 223134

    Nagoya, Aichi-ken, 464-8681

  • Okayama University Hospital /ID# 222990

    Okayama, Okayama-ken, 700-8558

  • Osaka City University Hospital /ID# 224269

    Osaka, Osaka, 545-8586

  • Tohoku University Hospital /ID# 223169

    Sendai, Miyagi, 9808574

  • NTT Medical Center Tokyo /ID# 223574

    Shinagawa-ku, Tokyo, 141-8625

  • Yamagata University Hospital /ID# 223032

    Yamagata, Yamagata, 990-9585

  • University of Fukui Hospital /ID# 223133

    Yoshida-gun, Fukui, 910-1193

Other trials in Japan

About this study

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

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.

Read more

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.

Being tested
Venetoclax, Cytarabine
Keywords
Acute Myeloid Leukemia (AML), Cancer, Venetoclax, Venclexta
Medical subject headings
Leukemia, Myeloid, Acute, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04509622
Study groupRoleWhat they receive
Venetoclax + Low-Dose Cytarabine (LDAC)ExperimentalParticipants 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.
Receives: Drug: Venetoclax; Drug: Cytarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 9 months after the first participant receives first dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2020
  2. Study start5 Oct 2020
  3. Primary completion15 Apr 2021
  4. Study completion15 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04509622
Sponsor's protocol ID
M19-916
Status last verified
May 2022
First submitted
10 Aug 2020
Last updated
5 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Venetoclax and Cytarabine in people with Acute Myeloid Leukemia (AML), run by AbbVie at 16 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (AEs) (time frame: Up to approximately 9 months after the first participant receives first dose of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04509622.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.

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