Double umbilical cord blood transplantation in high-risk haematological patients. A phase II study focussing on the mechanism of graft predominance

Phase 2

Recruiting

• Conditions: poor-risk hematological malignancy; 10018849

• Registration Number: NL-OMON39426
• Lead Sponsor: HOVO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

- Age 18-70years inclusive
- Diagnosis of poor-risk hematological malignancy or (V)SAA relapsing after or failing immunosuppressive therapy and meeting the criteria for a MUD allo SCT
- Lacking a sufficiently matched volunteer unrelated donor or lacking such a donor within the required time period of <= 2 months in case of urgently needed alloSCT
- Availability of 2 (>=4/6) matched UCB grafts with a total nuclear cell count > 4 x 107/kg (see paragraph 8.2).
- WHO performance status 0-2
- Written informed consent

Exclusion Criteria

- Bilirubin and/or transaminases > 2.5 x normal value
- Creatinine clearance < 40 ml/min
- Cardiac dysfunction (as defined in protocol in 8.1.2)
- Pulmonary function test with VC, FEV1 and/ or DCO < 50%
- Active, uncontrolled infection
- History of high dose total body irradiation
- Pregnant or lactating female
- HIV positivity;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- The proportion of patients with activated class II-specific T-cells (aTCs),<br /><br>defined as: the number of patients with aTCs, divided by the number of patients<br /><br>with class II mismatches for which there are tests available (defined as<br /><br>evaluable patients).<br /><br>- Transplant related mortality (TRM; defined as non-relapse mortality) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Cumulative incidence of engraftment<br /><br>- Cumulative incidence of graft failure<br /><br>- Time to neutrophil recovery<br /><br>- Time to lymphocyte recovery<br /><br>- Time to platelet recovery<br /><br>- Time to red blood cell transfusion independence<br /><br>- Count of total CD3+, CD4+ and CD8+ cells and CD3-CD16/56+ cells at 3, 6, 12<br /><br>and 24 months after UCBT<br /><br>- Incidence and grade of acute GVHD<br /><br>- Incidence of chronic GVHD<br /><br>- Incidence of infections<br /><br>- Progression free survival (PFS, i.e. time from transplantation until<br /><br>progression/relapse or death from any cause, whichever comes first)<br /><br>- Overall survival (OS) calculated from transplantation. </p><br>