A PHASE II OPEN-LABEL STUDY OF UM171-EXPANDED CORD BLOOD TRANSPLANTATION IN PATIENTS WITH HIGH AND VERY HIGH-RISK ACUTE LEUKEMIA/MYELODYSPLASIA.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517583-36-01

Acronym

ECT-001-CB.004

Enrollment

Registered

2024-11-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-29

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

Conditions

High risk and very high risk acute leukemia/myelodysplasia requiring an allogeneic haematopoietic stem cell transplantation

Brief summary

Evaluate relapse-free survival at 1- and 2-years post-transplant

Detailed description

Kinetics of hematopoietic engraftment (Neutrophil engraftment and Platelet engraftment), Transplant related mortality (TRM), Incidence of acute and chronic GVHD, Incidence of grade 3 or higher infectious complications, Incidence of pre-engraftment and engraftment syndrome requiring therapy

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Evaluate relapse-free survival at 1- and 2-years post-transplant	—

Secondary

Measure	Time frame
Kinetics of hematopoietic engraftment (Neutrophil engraftment and Platelet engraftment), Transplant related mortality (TRM), Incidence of acute and chronic GVHD, Incidence of grade 3 or higher infectious complications, Incidence of pre-engraftment and engraftment syndrome requiring therapy	—

Countries

Netherlands

Outcome results