Efficacy and safety of an innate allogeneic haematopoietic stem cells transplantation in patients with haematological malignancies

Efficacy and safety of an innate allogeneic haematopoietic stem cells transplantation in patients with haematological malignancies - Feasibility 'innate' allogeneic stem cells transplantion

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44165

Enrollment

Registered

2015-02-10

Start date

2016-04-17

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

blood cancer

Interventions

Reduced toxicity myeloablative conditioning regime, alphabeta T-cell depleted allogeneic stem cell graft, and preferably followed by a donor lymphocyte infusion (DLI).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Adults -Haematological malignancies eligible to allo-SCT -WHO performance status * 2 -Written informed consent

Exclusion criteria

Exclusion criteria: -Relapse of allo-SCT within 6 months after allo-SCT -Bilirubin and/or transaminases > 2.5 x normal value -Creatinine clearance

Design outcomes

Primary

Measure	Time frame
Transplantation related mortality within 100 days.	—

Secondary

Measure	Time frame
Feasibility of 'low dose DLI' at 100 days; engraftment, toxicity in terms of incidence of GVHD and infectious complications, chance of relapse.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)