Pediatric patients with ALL, AML, CML or MDS following hematopoietic stem cell transplantation Cancer Paediatric leukaemia
Conditions
Interventions
1. Treatment group will receive ASTL as prophylaxis and cidofovir as intervention.
2. Control group will receive placebo as prophylaxis and cidofovir as intervention.
Sponsors
Charité - University Medicine Berlin (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pediatric patients, aged 2 to 18 years with: 1. Acute leukemias (ALL) 2. Acute myeloid leukemia (AML) 3. Chronic myeloid leukemia (CML) 4. Myelodysplastic syndromes (MDS)
Exclusion criteria
Exclusion criteria: 1. Patients in relapse or progress of AML or ALL and blast crisis of CML at the time of randomization 2. All second transplants 3. AdV seronegative recipients with seronegative matched related donors (MRD) 4. Patients with severe non-hematopoietic organ toxicity grade 3-5 (according to the National Cancer Institute [NCI] and Cancer Therapy Evaluation Program [CTEP] reporting criteria) at the time of randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the treatment related mortality (TRM), this will come into effect if: 1. TRM exceeds 35% 2. Acute GVHD III/IV exceeds 25% 3. Chronic GVHD II exceeds 25% 4. Non-hematopoietic toxicity 3-5 (according to NCI CTEP reporting criteria) exceeds 40% | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acute and chronic GVHD assessed by standard clinical grading scheme 2. Early non-hematopoietic toxicity grade according to NCI CTEP common terminology criteria for adverse events 3. Frequency and duration of AdV reactivations | — |
Countries
Germany
Outcome results
None listed