Patients with high risk acute leukemia / MDS or relapse acute leukemia /MDS MedDRA version: 12.1 Level: LLT Classification code 10066481 Term: Hematological malignancy
Conditions
Interventions
Trade Name: zometa
Product Name: zometa
Pharmaceutical Form: Injection*
Sponsors
UMCU
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 4.1 Inclusion criteria ? Age 18-65 years ? Meeting the criteria for a allo-SCT and high risk disease * (see below) ? WHO performance status = 2 •Written informed consent *High risk disease as defined by: ? AML with monosomal karyotype, abnormal 3q26, t(9;22) EVI-1-expression, or complex karyotype in first CR •No CR after first induction cycle chemotherapy ? Relapsed AML (in case of second allo-SCT if relapse occurs 6 months after allo-SCT) in second or subsequent CR ? MDS with complex karyotype or -7, transfusion dependent or neutropenic with 30x109/l, T-ALL > 100x109/l) in first CR, or no CR after first induction but in CR after rescue chemotherapy ? Relapsed ALL (in case of second allo-SCT if relapse occurs 6 months after allo-SCT) in second or subsequent CR Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 4.2 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test 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)by assessing: ? Time to neutrophil engraftment ? Time to platelet engraftment ? Time to donor engraftment (chimerism >95%) ? Time to red blood cell transfusion independence ? Incidence and grade of acute GvHD ? Incidence and grade of chronic GvHD ? Ability to generate and apply an iDLI ? Incidence of infections ? Transplant related mortality (TRM) ;Secondary Objective: ? Immune reconstitution by counting total number of CD3+ T cells, CD4+ and CD8+ subtyping of T cells, CD3-CD16/56+ (NK cells), ??T-cells at 3, 6, 12 and 24 months after transplantation ? Progression free survival (PFS, i.e. time from transplantation until progression/relapse or death from any cause, whichever comes first) ? 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 ;Primary end point(s): 7.1.1 Main study endpoints ? Time to neutrophil engraftment ? Time to platelet engraftment ? Time to donor engraftment (chimerism >95%) ? Time to red blood cell transfusion independence ? Incidence and grade of acute GvHD ? Incidence and grade of chronic GvHD ? Ability to generate and apply an iDLI ? Incidence of infections ? Transplant related mortality (TRM) | — |
Countries
Netherlands
Outcome results
None listed