RICAZA
Trial overview
Phase II study of the tolerability of adjunctive azacitidine in patients undergoing reduced intensity allogeneic stem cell transplantation for acute myeloid leukaemia and myelodysplasia.
Inclusion criteria
Patients >18 years in whom allogeneic transplantation using a myeloablative conditioning regimen is contra-indicated.
Diagnosis:
- Patients who fulfil WHO criteria for AML12
- Patients who fulfil WHO criteria for MDS12
Patients with an HLA identical sibing or suitable matched unrelated donor and considered fit for reduced intensity transplantation.
Written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Willing and able to comply with the protocol for the duration of the study.
Exclusion criteria
Patients with contraindications to receiving Fludarabine, Melphalan, Alemtuzumab or Azacitidine.
Pregnant or lactating women or adults of reproductive potential not willing to use appropriate medically approved contraception during the trial and for 12 months post Azacitidine.
Any co-morbidity that in the investigators opinion will affect the patient's participation in this study.
Contact details
Other trials currently active for Acute Myeloid Leukaemia
Phase II study of the tolerability of adjunctive azacitidine in patients undergoing reduced intensity allogeneic stem cell transplantation for acute myeloid leukaemia and myelodysplasia.
The AML 17 trial has two distinct parts:
i.For patients with acute myeloid leukaemia (AML), (other than acute promyelocytic leukaemia) and High Risk Myelodysplasia, as defined by the WHO Classification (2001) (Appendix A, protocol).
ii.For adults with acute promyelocytic leukaemia (APL).
A pilot safety / tolerability study of Lenalidomide administered as monotherapy and in combination with standard chemotherapy for
Acute Myeloid Leukaemia / high-risk Myelodysplastic Syndrome with structural abnormalities of chromosome 5
Novartis Panobinostat Refractory AML
A Phase II Study of Oral Single Agent Panobinostat in Patients with Refractory de novo or secondary Acute Myelogenous Leukemia (AML)
The AML16 Trial will evaluate several relevant therapeutic questions in Acute Myeloid Leukaemia (AML), as defined by the WHO, and High Risk Myelodysplastic Syndrome. The trial is primarily designed for patients over 60 years, but younger patients who may not be considered suitable for the concurrent MRC AML Trial for
younger patients may also enter.
Tags
aml azacitidine myelodysplasia ric allogeneic tranpslant melphalan