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).

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000110987

Acronym

Rev/Aza

Enrollment

Registered

2011-02-01

Start date

2010-01-18

Completion date

2013-05-09

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 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.

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 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.

Study design

Allocation

Non-randomised trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

-Acute Myeloid Leukaemia (AML) patients in complete remission (CR) or complete remission with incomplete count recovery (CRi). -Life expectancy greater than 3 months. -Eastern cooperative oncology group (ECOG) status 0-3 -Blood electrolytes level within normal limits. -Adequate renal functions. -Adequate hepatic functions -No uncontrolled active infection. -Women of child bearing age must have a negative pregnancy test prior to start of study therapy, and she must agree to ongoing pregnancy tests. -Male subjects must agree to use protection during sexual contact with a woman of child bearing potential. They must also agree not to donate semen during study drug therapy and for a period after study drug therapy.

Exclusion criteria

-Any serious medical or psychiatric conditions. -History of major non-compliance to medication. -Evidence of Central Nervous System (CNS) leukemia. -Uncontrolled viral infection with known Human Immunodeficiency Virus (HIV) or Hepatitis type B or C. -Previous failure of response to azacitidine therapy. -Currently active gastrointestinal disease. -Any other concurrent severe and/or oncontrolled medical conditions. -Female patients who are pregnant or breastfeeding and the lack of adequate contraception in females.

Outcome results