Phase ll Study of the Adjunctive Use of Azacitidine in Patients Undergoing Reduced Intensity Allogeneic Transplantation for Acute Myeloid Leukaemia - RICAZA

Phase 1

• Conditions: Patients who have Acute Myeloid Leukaemia (AML) will be recruited to this trial.; MedDRA version: 9.1 Level: LLT Classification code 10000880 Term: Acute myeloid leukaemia

• Registration Number: EUCTR2007-006475-36-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-15
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified