NCT04253314

Brief Summary

Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well Venetoclax works to treat AML in adult participants who are ineligible for standard induction therapy in Russian Federation. Venetoclax is a drug approved to treat Acute Myeloid Leukemia. All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a diagnosis of AML who are ineligible for standard induction therapy will be enrolled. Around 50 participants will be enrolled in the study in approximately 15 sites in Russian Federation. Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 18 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice (approximately every 3 months) and participants will be followed for 18 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 13, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2023

Completed
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

2.9 years

First QC Date

January 31, 2020

Last Update Submit

November 6, 2024

Conditions

Acute Myeloid Leukemia (AML)

Keywords

Acute Myeloid Leukemia (AML)VenetoclaxVenclexta

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Defined as the time (in days) between the date of first Venetoclax intake to date of death.

    Approximately 18 months

Secondary Outcomes (16)

  • Overall Response Rate

    Approximately 18 months

  • Best Overall Response Rate

    Approximately 18 months

  • Best complete Remission

    Approximately 18 months

  • Time to First Response

    Approximately 18 months

  • Time to Best Response to Treatment

    Approximately 18 months

  • +11 more secondary outcomes

Study Arms (1)

Venetoclax Participants

Participants treated with Venetoclax in accordance with approved local label. Decision to treat with Venetoclax was made prior to offering participation in this study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult participants with acute myeloid leukemia (AML) treated with Venetoclax per approved local label in Russian Federation.

You may qualify if:

  • Newly diagnosed acute myeloid leukemia (AML) (de novo or secondary) and eligible to receive Venetoclax as per Russian Ministry of Health label
  • Ineligible for standard induction therapy with cytarabine and anthracycline
  • Eastern Cooperative Oncology Group (ECOG) score \>2
  • White blood cell counts \<25 x 109 per liter
  • Started Venetoclax within 4 weeks of enrolling in study

You may not qualify if:

  • Acute promyelocytic leukemia
  • Contraindications to Venetoclax as listed on the approved local label in Russian Federation
  • Neuroleukemia - active central nervous system (CNS) involvement
  • Participation in a clinical trial with an investigational drug for AML within 30 days prior to Venetoclax treatment initiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Moscow State budget healthcare /ID# 218569

Moscow, Moscow, 125284, Russia

Location

Saratov State Medical University n.a. V.I. Razumovskiy /ID# 226059

Saratov, Saratov Oblast, 410012, Russia

Location

Hematology department State budgetary health care institution Volgograd region /ID# 229813

Volgograd, Volgograd Oblast, 400138, Russia

Location

Regional Clinical Hospital of Irkutsk /ID# 218570

Irkutsk, 664049, Russia

Location

Clinical Medico-Sanitary Unit #1 /ID# 222502

Perm, 614077, Russia

Location

Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 229812

Saint Petersburg, 191024, Russia

Location

R.M.Gorbacheva Research Institute of Paediatric Oncology, Haematology and Transp /ID# 224831

Saint Petersburg, 197101, Russia

Location

Almazov National Medical Research Centre /ID# 218571

Saint Petersburg, 197341, Russia

Location

Republican Hospital #1 - National Center of Medicine of Sakha (Yakutia) /ID# 224830

Yakutsk, 677008, Russia

Location

Sakhalin Regional Clinical Hospital /ID# 222501

Yuzhno-Sakhalinsk, 693004, Russia

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 5, 2020

Study Start

March 13, 2020

Primary Completion

February 16, 2023

Study Completion

February 16, 2023

Last Updated

November 7, 2024

Record last verified: 2024-11

Locations

RU(10)