Sample Collection Study to Monitor the Risk of Malignancy Due to Insertional Oncogenesis in Early Onset Patients with Metachromatic Leukodystrophy Treated with OTL-200 in the Clinical Development Program

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522275-28-00

Enrollment

Registered

2026-06-22

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-23

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

Conditions

Metachromatic leukodystrophy

Brief summary

Incidence of malignancies due to insertional oncogenesis reported during the study

Detailed description

Incidence of clonal abundance ≥30% reported during the study.

Interventions

DRUGLibmeldy 2-10 x 10^6 cells/mL dispersion for infusion

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Incidence of malignancies due to insertional oncogenesis reported during the study	—

Secondary

Measure	Time frame
Incidence of clonal abundance ≥30% reported during the study.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 24, 2026