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.
Studientyp
Interventional
(ICTRP)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Schweiz, Australien
(ICTRP)
Allgemeine Auskünfte
Erasmus MC, Universitair Medisch Centrum Rotterdam
(ICTRP)
Wissenschaftliche Auskünfte
Erasmus MC, Universitair Medisch Centrum Rotterdam
(ICTRP)
Wissenschaftlicher Titel
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)
Studiendesign
Randomized controlled trial, Open (masking not used), Active, Parallel, Treatment (ICTRP)
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
04.04.2014 (ICTRP)
Einschluss des ersten Teilnehmers
26.01.2010 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Erasmus MC, Universitair Medisch Centrum Rotterdam (ICTRP)
Sekundäre IDs
2007-003514-34, NCT00766779, NL24236.000.08 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://onderzoekmetmensen.nl/en/trial/39855 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar