A phase II study to assess engraftment and engraftment kinetics after double cord blood transplantation with a reduced-intensity conditioning regimen in patients eligible for allogeneic stem cell transplantation lacking a matched unrelated donor.

A phase II study to assess engraftment and engraftment kinetics after double cord blood transplantation with a reduced-intensity conditioning regimen in patients eligible for allogeneic stem cell transplantation lacking a matched unrelated donor. - HO106 Double UCBT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35273

Enrollment

Registered

2008-05-15

Start date

2008-11-26

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Acute Leukemia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 65 years old or younger. High risk disease as specified in protocol. Lacking a sufficiently matched volunteer unrelated donor or lacking such a donor within the required timeperiod of no more than 2 months in case of urgently needed alloSCT. Availability of 2 sufficiently matched UCB grafts with a total nulear cell count > 4 x 10 7/kg.

Exclusion criteria

Exclusion criteria: Bilirubin and/of transaminases > 2.5 x normal value. Creatininge clearance

Design outcomes

Primary

Measure	Time frame
Primary endpoint is the cumulative incidence of graft failure.	—

Secondary

Measure	Time frame
Secundary end points: time to engraftment of different cell lines, incidence of graft vs host disease, incidence of infection, TRM, disease-free survival and overall survival.	—

Countries

Netherlands

Outcome results