High risk acute leukemia or MDS or relapse acute leukemia or MDS patients
Conditions
Interventions
Selection of T cells and depletion of B-cell in the alloSCT. After that zolendronic acid administations and iDLI after immunosupressive medication is stopped.
Normally there is no selection of T oor B
Sponsors
UMC Utrecht
Heidelberglaan 100
3584 CX Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years; 2. Meeting the criteria for a allo-SCT and high risk disease * (see below); 3. WHO performance status ≤ 2; 4. Written informed consent. *High risk disease as defined by: 1. AML with monosomal karyotype, abnormal 3q26, t(9;22) EVI-1-expression, or complex karyotype in first CR; 2. No CR after first induction cycle chemotherapy; 3. Relapsed AML (in case of second allo-SCT if relapse occurs 6 months after allo-SCT) in second or subsequent CR; 4. 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; 6. Relapsed ALL (in case of second allo-SCT if relapse occurs 6 months after allo-SCT) in second or subsequent CR.
Exclusion criteria
Exclusion criteria: 1. Relapse of allo-SCT within 6 months after allo-SCT; 2. Relapse acute promyelocyten leukemia; 3. Bilirubin and/or transaminases > 2.5 x normal value; 4. Creatinine clearance < 40 ml/min; 5. Cardiac dysfunction as defined by: A. Unstable angina; B. Unstable cardiac arrhythmias. 6. Active, uncontrolled infection; 7. HIV positivity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 1. Time to neutrophil engraftment; 2. Time to platelet engraftment; 3. Time to donor engraftment (chimerism >95%); 4. Time to red blood cell transfusion independence; 5. Incidence and grade of acute GvHD; 6. Incidence and grade of chronic GvHD; 7. Ability to generate and apply an iDLI; 8. Incidence of infections; 9. Transplant related mortality (TRM). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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; 2. Progression free survival (PFS, i.e. time from transplantation until progression/relapse or death from any cause, whichever comes first); 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. | — |
Contacts
Public ContactL.C.J. Boome, te
Heidelberglaan 100
Outcome results
None listed