E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients who have Acute Myeloid Leukaemia (AML) will be recruited to this trial. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000880 |
E.1.2 | Term | Acute myeloid leukaemia |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the safety and tolerability of Azacitidine in patients following reduced intensity conditioned allogeneic transplantation for AML. |
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E.2.2 | Secondary objectives of the trial |
-To evaluate the effect of Azacitidine on the kinetics of disease relapse. -To document the impact of adjunctive Azacitidine on GVHD and chimerism (lineage specific where possible).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients >18 years and in whom allogeneic transplantation using a myeloablative conditioning regimen is contra-indicated. 1) Diagnosis • Patients who fulfil WHO criteria for AML 2) Patients with a HLA identical sibling or suitable matched unrelated donor. Suitable match equals no greater than a single allele mismatch and considered fit for reduced intensity transplant. 3) Give 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. 4) Be willing and able to comply with the protocol for the duration of the study.
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E.4 | Principal exclusion criteria |
Exclusion Criteria: 1) Patients with contraindications to receiving transplant conditioning therapy or Azacitidine. 2) 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 study. 3) Any co-morbidity that in the investigators opinion will affect the patients participation in this study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Document the tolerability of Azacitidine post transplant |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The entire trial will be stopped if: •Azacitidine is considered too toxic to continue treatment prior to the required number of patients being recruited •The stated number of patients to be recruited is reached. •The stated objectives of the trial are achieved.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |