A Study Comparing Chemotherapy With and Without Venetoclax in Children and Young Adults With Acute Myeloid Leukemia

Comparison of Outcome of Intensive Chemotherapy With and Without Venetoclax in Pediatric and Young Adult Acute Myeloid Leukemia Patients: A Non-Randomized Interventional Study - VEN-INTENSE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/095779

Enrollment

Registered

2025-10-09

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C920- Acute myeloblastic leukemia

Interventions

Intervention1: Tablet Venetoclax along with Intensive chemotherapy: Tablet Venetoclax at a dose of 50-100 mg per oral once daily for 7 days along with intensive chemotherapy (e.g., 3+7 induction or eq

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients up to 39 years of age diagnosed with Acute Myeloid Leukemia (AML). 2.Patients eligible for intensive chemotherapy. 3.Written informed consent obtained from parents/guardians and assent from patients when appropriate.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to Venetoclax. 2. Acute Promyelocytic leukemia 3. Pregnant & Lactating mothers

Design outcomes

Primary

Measure	Time frame
Post-induction flowcytometric measurable residual disease (Flow-MRD) responseTimepoint: 18 months	—

Secondary

Measure	Time frame
Post-induction morphological complete response (CR) ratesTimepoint: 18 months;Treatment-related adverse event profileTimepoint: 18 months	—

Countries

India

Contacts

Public ContactDr Nikhil Nagpal

AIIMS Rishikesh

nath.uttam@gmail.com9433982756

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026