A phase I/ II study;Efficacy and safety of alpha / beta T- /CD19B-cell depleted allogeneic haematopoietic stem cells transplantation in high risk or relapsed acute leukaemia / MDS followed by an innate donor lymphocyte infusion (iDLI)
Phase 2
Completed
- Conditions
- leukemia bloodcancer10024324
- Registration Number
- NL-OMON35919
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Age 18-65 years
Meeting the criteria for an allo-SCT and high risk leukemic disease
WHO PS status <= 2
Written informed consent
Exclusion Criteria
Relapse of allo-SCT within 6 months after allo-SCT
Relapse acute promyelocyten leukemia
Bilirubin and/or transaminases > 2.5 x normal value
Creatinine clearance < 40 ml/min
Cardiac dysfunction as defined by:
Unstable angina
Unstable cardiac arrhythmias
Active, uncontrolled infection
HIV positivity
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Feasibility with respect to engraftment, toxicity in terms of incidence of<br /><br>graft versus host disease and infectious complications.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Immune reconstitution<br /><br>Progression free survival<br /><br>Overall survival</p><br>