A phase I/ II study.Efficacy and safety of alpha / betaT- /CD19B-cell depleted allogeneic haematopoietic stem cells transplantation in high risk or relapsed acute leukaemia / MDS followed by an innate donor lymphocyte infusion (iDLI).
Completed
- Conditions
- High risk acute leukemia or MDS or relapse acute leukemia or MDS patients
- Registration Number
- NL-OMON28903
- Lead Sponsor
- MC UtrechtHeidelberglaan 1003584 CX Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Age 18-65 years;
2. Meeting the criteria for a allo-SCT and high risk disease * (see below);
Exclusion Criteria
1. Relapse of allo-SCT within 6 months after allo-SCT;
2. Relapse acute promyelocyten leukemia;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility and safety of alpha/ betaT-/CD19 B-cell depleted allo-SCT in high risk or relapsed acute leukaemia / MDS followed by an innate donor lymphocyte infusion (iDLI) <br>by assessing:<br /><br>1. Time to neutrophil engraftment;<br /><br>2. Time to platelet engraftment;<br /><br>3. Time to donor engraftment (chimerism >95%);<br /><br>4. Time to red blood cell transfusion independence;<br /><br>5. Incidence and grade of acute GvHD;<br /><br>6. Incidence and grade of chronic GvHD;<br /><br>7. Ability to generate and apply an iDLI;<br /><br>8. Incidence of infections;<br /><br>9. Transplant related mortality (TRM).
- Secondary Outcome Measures
Name Time Method 1. Immune reconstitution by counting total number of CD3+ T cells, CD4+ and CD8+ subtyping of T cells, CD3-CD16/56+ (NK cells), alpha / beta T-cells at 3, 6, 12 and 24 months after transplantation;<br /><br>2. Progression free survival (PFS, i.e. time from transplantation until progression/relapse or death from any cause, whichever comes first);<br /><br>3. Overall survival (OS) calculated from transplantation. Patients still alive or lost to follow up are censored at the date they were last known to be alive.