Relapsed Acute Lymphoblastic Leukemia (ALL)
Conditions
Brief summary
SR induction: Event-free survival (EFS), SR-MRD good response consolidation: DFS, HR with CR2 consolidation: DFS, IEM: EFS
Detailed description
SR induction: MRD negativity rate after induction, SR induction: Proportion of patients requiring allo-HSCT, SR induction: OS, SR induction: Toxicity (assessed by CTCAE grades and SAE reports), SR induction: Rate of patients with CD19 positive cells after SCB1 prior to Blinatumomab, SR-MRD good response consolidation: OS, SR-MRD good response consolidation: Toxicity (quantified by CTCAE grades and SAE reports), HR with CR2 consolidation: OS, HR with CR2 consolidation: MRD negativity rates before allo-HSCT, HR with CR2 consolidation: allo-HSCT rates, IEM: EFS by MRD at relapse diagnosis (cut-off 10-4), IEM: OS, IEM: DFS by MRD after induction (cut-off 10-4) in patients with BM MRD > 10e-4 at relapse, Serum pharmacokinetic parameters of InO (Cmax and Ctrough)
Interventions
DRUGMETHOTREXATE
DRUGHOLOXAN 1000 mg Pulver zur Herstellung einer Injektionslösung
DRUGELDISINE® 5 mg Pulver zur Herstellung einer Injektionslösung Vindesinsulfat
DRUGSolu-Dacortin 250 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung oder Infusionslösung
DRUGINOTUZUMAB OZOGAMICIN
DRUGCytarabine Accord Healthcare 20 mg/ml injektio-/infuusioneste
DRUGliuos
DRUGMercaptopurine 50mg tablets
DRUGZavedos® 5 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung Wirkstoff: Idarubicinhydrochlorid
DRUGDEXAMETHASONE MEDISOL 8 mg/2 ml
DRUGsolution injectable
DRUGThioguanin "Aspen" 40mg Tabletten
DRUGMetex 50 mg/ml injekcinis tirpalas užpildytame švirkšte
Sponsors
Charite Universitaetsmedizin Berlin KöR
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SR induction: Event-free survival (EFS), SR-MRD good response consolidation: DFS, HR with CR2 consolidation: DFS, IEM: EFS | — |
Secondary
| Measure | Time frame |
|---|---|
| SR induction: MRD negativity rate after induction, SR induction: Proportion of patients requiring allo-HSCT, SR induction: OS, SR induction: Toxicity (assessed by CTCAE grades and SAE reports), SR induction: Rate of patients with CD19 positive cells after SCB1 prior to Blinatumomab, SR-MRD good response consolidation: OS, SR-MRD good response consolidation: Toxicity (quantified by CTCAE grades and SAE reports), HR with CR2 consolidation: OS, HR with CR2 consolidation: MRD negativity rates before allo-HSCT, HR with CR2 consolidation: allo-HSCT rates, IEM: EFS by MRD at relapse diagnosis (cut-off 10-4), IEM: OS, IEM: DFS by MRD after induction (cut-off 10-4) in patients with BM MRD > 10e-4 at relapse, Serum pharmacokinetic parameters of InO (Cmax and Ctrough) | — |
Countries
Austria, Czechia, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Spain, Sweden
Outcome results
None listed