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Venetoclax in Combination With Standard Induction and Consolidation Chemotherapy in Newly Diagnosed Young AML Patients

NCT ID: NCT06162325

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-21

Study Completion Date

2025-12-31

Brief Summary

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The goal of this observational study is to to evaluate the efficacy and safety of Venetoclax in combination with DA60(daunorubicin 60 mg/m2/d for 3 days, and cytarabine 100 mg/m2 every 12 h for 7 days) induction and HD-AraC(cytarabine 3 g/m2 every 12 h for 3 days) consolidation, in young patients with newly diagnosed acute myeloid leukemia (AML).

Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed, morphologically documented AML based on the World Health Organization (WHO) 2016 classification.
* Age ≥ 18 years and ≤ 59 years
* Have been treat with the "venetoclax in combination with standard induction and consolidation chemotherapy" therapy, and in follow-up.
* Be comprehensive of the research, and able to provide informed consent.

Exclusion Criteria

* Diagnosis of acute promyelocytic leukemia (APL).
* Prior treatment for AML, except for: leukapheresis, hydroxyurea, and growth factor/cytokine.
* Unable to understand or participate.
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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AML-VEN PLUS

Identifier Type: -

Identifier Source: org_study_id