A Phase 1/2, Open-label Study Evaluating the Efficacy, Safety, and Pharmacokinetics (PK) of Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 years of age with CBFA2T3::GLIS2 Acute Myeloid Leukemia (AML)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506240-16-00

Acronym

REFRaME-P1

Enrollment

Registered

2024-10-21

Start date

Unknown

Completion date

2025-04-04

Last updated

2025-02-12

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

Conditions

Acute Myeloid Leukemia (AML)

Brief summary

Complete remission (CR) rate

Detailed description

Duration of CR, Response rate including complete remission with partial hematologic recovery (CRh) rate [CR + CRh], Event-free survival (EFS), Relapse-free survival (RFS), Overall survival (OS), Incidence and severity of AEs and clinical laboratory abnormalities per NCI CTCAE v5.0., Concentration of luveltamab tazevibulin (ADC, TAb, and SC209) in the blood., Incidence of ADAs

Interventions

None listed

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Secondary

Measure	Time frame
Duration of CR, Response rate including complete remission with partial hematologic recovery (CRh) rate [CR + CRh], Event-free survival (EFS), Relapse-free survival (RFS), Overall survival (OS), Incidence and severity of AEs and clinical laboratory abnormalities per NCI CTCAE v5.0., Concentration of luveltamab tazevibulin (ADC, TAb, and SC209) in the blood., Incidence of ADAs	—

Primary

Measure	Time frame
Complete remission (CR) rate	—

Countries

Austria, Denmark, France, Germany, Italy, Netherlands, Spain

Outcome results