CompletedPhase 2ACTRN12611000110987

To examine the safety and tolerability of lenalidomide in combination with 5-azacitidine as maintenance therapy for Acute Myeloid Leukaemia (AML) in complete remission after intensive chemotherapy.

A phase Ib/II clinical evaluation of the safety and tolerability of maintenance 5-Azacitidine combined with Lenalidomide in patients complete remission after cytoreductive chemotherapy for acute myeloid leukaemia (AML).


Sponsor

Andrew Wei

Enrollment

30 participants

Start Date

Jan 18, 2010

Study Type

Interventional

Conditions

Summary

This study looks at the safety and tolerability of the drug lenalidomide in combination with 5-azacitidine when used as maintenance therapy for patients with Acute Myeloid Leukaemia (AML) who are in complete remission. Who is it for? You can join this study if you are an Acute Myeloid Leukaemia (AML) patient who is in complete remission (CR), or complete remission with incomplete count recovery (CRi). Trial details Participants will be split into one of 7 cohorts (treatment groups) for this trial, with each cohort receiving varying doses of subcutaneous injections of Azacitidine on days 1-5, followed by oral tablets of Lenalidomide from days 5-25 of each treatment cycle. Participants will be assessed at regular intervals to determine their response to treatment. The aim of this study is to determine the safety and tolerability of these combination doses.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether two medications (lenalidomide and azacitidine) taken together as maintenance therapy can safely help keep acute myeloid leukemia (AML) in remission after chemotherapy. It is for adults whose leukemia has responded well to initial treatment.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Sub cutaneous Azacitidine day 1-5, oral Lenalidomide day 5-25. 7 Cohorts. Cohort A: 50mg/m2 Azacitidine, nil Lenalidomide. Cohort B: 50mg/m2 Azacitidine, 5mg Lenalidomide. Cohort C: 60mg/m2 Azacitidin

Sub cutaneous Azacitidine day 1-5, oral Lenalidomide day 5-25. 7 Cohorts. Cohort A: 50mg/m2 Azacitidine, nil Lenalidomide. Cohort B: 50mg/m2 Azacitidine, 5mg Lenalidomide. Cohort C: 60mg/m2 Azacitidine, 5mg Lenalidomide. Cohort D: 60mg/m2 Azacitidine, 10mg Lenalidomide. Cohort E: 75mg/m2 Azacitidine, 10mg Lenalidomide. Cohort F:75mg/m2 Azacitidine, 15mg Lenalidomide. Cohort G: 75mg/m2 Azacitidine, 20mg Lenalidomide.


Locations(1)

VIC, Australia

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ACTRN12611000110987