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ADVL2322; 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); REFRaME-P1

Recruiting

This study is testing a new treatment, luveltamab tazevibulin, for infants and children under 12 with relapsed/refractory CBFA2T3::GLIS2 AML with ā‰„ 5% bone marrow involvement with leukemic blasts. The treatment will be given at two dose levels (3.5 or 4.3 mg/kg every 2 weeks), and participants will be randomly assigned to one dose level.

I'm interested

Male or Female
Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Age: < 12 years.
• Diagnosis: relapsed or refractory Acute Myeloid Leukemia (AML) with CBFA2T3::GLIS2 fusion
• Required documentation of the CBFA2T3::GLIS2 translocation by Next Generation Sequencing FoundationOneĀ® Heme assay.
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• Active CNS disease at the time of enrollment
• Subjects with the following constitutional conditions are not eligible: Fanconi anemia, Shwachman Diamond syndrome, subjects with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21, telomere disorders, germline predispositions known, or suspected by the treating physician to increase risk of toxicity with AML therapy.

Blood Disorders, Cancer

Acute Myeloid Leukemia (AML), refractory, relapsed

Allison Fullenkamp - fulle631@umn.edu
Robin Williams
PHASE1
STUDY00022403
See this study on ClinicalTrials.gov

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