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.
- Conditions
- Acute Myeloid Leukaemia in complete remission.Blood - Haematological diseasesCancer - Leukaemia - Acute leukaemia
- Registration Number
- ACTRN12611000110987
- Lead Sponsor
- Andrew Wei
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
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.
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximal tolerated dose of lenalidomide in combination with a 5 day regimen of 5-azacitidine.[Assessed at Day 1-5, 12, 19 and 26 of each cycle.];Dose limiting toxicities of lenalidomide in combination with a 5 day regimen of 5-azacitidine.[Assessed at Day 1-5, 12, 19 and 26 of each cycle.]
- Secondary Outcome Measures
Name Time Method Adverse events as defined by type, frequency, severity, timing and relatedness of adverse events(AEs) of lenalidomide in combination with 5-azacitidine. AEs are assessed by Common Terminology Criteria for Adverse Events (CTCAE) by blood tests and medical consultations with patients.[For the duration the patient is on treatment plus one month follow up.];Treatment related mortality by weekly blood tests, consultations with a physician and data linkage to patient medical records.[As they occur during time patient is on trial and and for up to 12 months following study completion.];Laboratory assessments of haematology, coagulation, blood chemistry and vital signs.[Each cycle on day 1, 12, 19 and 26.]