Azacitidine use in elderly patients (over 65) with high risk myelodysplasia/acute myeloid leukaemia.

The effect of subcutaneous azacitidine on overall survival using the alternate regimen of 75mg/m2/day for 3 days/week (Monday, Wednesday, Friday) for 2 weeks each month in elderly patients (over 65 years old) with high risk myelodysplasia/acute myeloid leukaemia.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000358741

Enrollment

Registered

2013-04-05

Start date

2013-04-15

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is evaluating the effect of less frequent azacitidine treatment in elderly patients with high risk myelodysplasia/acute myeloid leukaemia. Who is it for? You may be eligible to join this study if you are aged over 65 years and have been diagnosed with high risk myelodysplasia or acute myeloid leukaemia on bone marrow biopsy. Trial details: All participants in this trial will received the drug azacitidine at a dose of 75mg/m2 three times a week (Monday, Wednesday, Friday) for two consecutive weeks every 4 weeks. Participants will be assessed for up to 18 months post treatment in order to evaluate survival and response to treatment.

Interventions

Patients with high risk myelodysplasia/acute myeloid leukaemia administered azacitidine 75mg/m2 subcutaneously 3 times a week (Monday, Wednesday, Friday) for two consecutive weeks every 4 weeks until unacceptable toxicity, failure of therapy to show improvement in cytopenia, or disease progression/death.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

>65 years old Diagnosis of high-risk myelodysplasia or acute myeloid leukaemia on bone marrow biopsy.

Exclusion criteria

Azacitidine use contraindicated.

Outcome results