A Randomized Phase III study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission.
Tipo di studio
Interventional
(ICTRP)
Intervento studiato
Patients with a donor will be randomized between standard treatment and
treatment with
Fludarabine, 200 cGy TBI and allogeneic HCT followed by immunosuppression with
CyA and MMF. For patients of 60-65 years the standard treatment is autologous
HCT or chemotherapy. Patients of 66 years and older will receive no further
treatment. This also applies to both groups of patients without a donor.
Patients are entered in CR1 after induction chemotherapy. Induction is
according to each participating centre or study group, which applies their own
protocols.
(ICTRP)
Malattie studiate
Acute myeloid leukemia
leukemia
(ICTRP)
Maximum age: 64
Minimum age: 18
Inclusion criteria:
- Age >= 60years and <= 75 years
- AML as defined by WHO
- Refractory anaemia with excess of blasts (RAEB)
- primary and secondary AML
- First complete remission following one or two cycles of induction chemotherapy, according to current participating cooperative group protocols
- Karnofsky score > 70%
- Written informed consent
(ICTRP)
Criteri di esclusione
Exclusion criteria:
- AML FAB M3
- Organ dysfunction
* Patients with creatinine clearance < 50 ml/min
* Cardiac ejection fraction < 40%
* Severe defects in pulmonary function testing as defined by the pulmonary consultant, or receiving supplementary continuous oxygen
* Liver function tests: total bilirubin > 2x the upper limit of normal, SGOT and SGPT 4x the upper limit of normal
- Karnofsky score < 70%
- Patients with poorly controlled hypertension
- HIV positivity
(ICTRP)
Luogo dello studio
Svizzera, Australia
(ICTRP)
Informazioni generali
Erasmus MC, Universitair Medisch Centrum Rotterdam
(ICTRP)
Informazioni scientifiche
Erasmus MC, Universitair Medisch Centrum Rotterdam
(ICTRP)
Titolo accademico
A Randomized Phase III study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission. - HOVON 93 AML/HCT vs CT elderly AML (ICTRP)
Disegno dello studio
Randomized controlled trial, Open (masking not used), Active, Parallel, Treatment (ICTRP)
Endpoint primari e secondari
Leukemia-free survival (LFS)
(ICTRP)
- Overall survival (median survival if possible; otherwise survival until 40%
or 30% alive)
- Incidence of relapse
- Incidence of myelosuppression (ANC < 500/mm? for > 2 days, platelets <
20,000/mm? for > 2 days) after initial PBSC infusion
- Incidence of aplasia after DLI
- Incidence of grades 2-4 acute GvHD after transplant
- Incidence of grades 2-4 acute GvHD after DLI
- Incidence of grades chronic extensive GvHD after DLI
(ICTRP)
Data di registrazione
04.04.2014 (ICTRP)
Inclusione del primo partecipante
26.01.2010 (ICTRP)
Sponsor secondari
non disponibile
Contatti aggiuntivi
Erasmus MC, Universitair Medisch Centrum Rotterdam (ICTRP)
ID secondari
2007-003514-34, NCT00766779, NL24236.000.08 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://onderzoekmetmensen.nl/en/trial/39855 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile