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Trial registered on ANZCTR


Registration number
ACTRN12611000110987
Ethics application status
Approved
Date submitted
4/10/2010
Date registered
1/02/2011
Date last updated
30/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
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.
Scientific title
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).
Secondary ID [1] 252815 0
NA
Universal Trial Number (UTN)
Trial acronym
Rev/Aza
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukaemia in complete remission. 258325 0
Condition category
Condition code
Blood 258511 258511 0 0
Haematological diseases
Cancer 259177 259177 0 0
Leukaemia - Acute leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 257339 0
Prevention
Comparator / control treatment
7 cohorts of different dose regimens. Cohort A would be the control cohort with only Azacitidine being administered and no lenalidomide.
Control group
Dose comparison

Outcomes
Primary outcome [1] 259347 0
Maximal tolerated dose of lenalidomide in combination with a 5 day regimen of 5-azacitidine.
Timepoint [1] 259347 0
Assessed at Day 1-5, 12, 19 and 26 of each cycle.
Primary outcome [2] 262032 0
Dose limiting toxicities of lenalidomide in combination with a 5 day regimen of 5-azacitidine.
Timepoint [2] 262032 0
Assessed at Day 1-5, 12, 19 and 26 of each cycle.
Secondary outcome [1] 265811 0
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.
Timepoint [1] 265811 0
For the duration the patient is on treatment plus one month follow up.
Secondary outcome [2] 265812 0
Treatment related mortality by weekly blood tests, consultations with a physician and data linkage to patient medical records.
Timepoint [2] 265812 0
As they occur during time patient is on trial and and for up to 12 months following study completion.
Secondary outcome [3] 265813 0
Laboratory assessments of haematology, coagulation, blood chemistry and vital signs.
Timepoint [3] 265813 0
Each cycle on day 1, 12, 19 and 26.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2010
Actual
18/01/2010
Date of last participant enrolment
Anticipated
Actual
9/05/2013
Date of last data collection
Anticipated
Actual
20/11/2014
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 257794 0
Hospital
Name [1] 257794 0
Hospital department name: Malignant Haematology and stem cell transplant Service
Country [1] 257794 0
Australia
Primary sponsor type
Individual
Name
Andrew Wei
Address
The Alfred Hospital
Ground floor, William Buckland Building
Commercial Road
Prahran, Victoria. 3181
Country
Australia
Secondary sponsor category [1] 256997 0
Commercial sector/Industry
Name [1] 256997 0
Celgene International
Address [1] 256997 0
Route de Perreux 1,
2017 Boudry
Country [1] 256997 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259819 0
Alfred Health Human Research Ethics Committee
Ethics committee address [1] 259819 0
The Alfred Hospital
Commercial Road,
Prahran, Victoria. 3181
Ethics committee country [1] 259819 0
Australia
Date submitted for ethics approval [1] 259819 0
Approval date [1] 259819 0
22/10/2009
Ethics approval number [1] 259819 0
1/09/0294

Summary
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.
Trial website
Trial related presentations / publications
Abstract: "Maintenance lenalidomide in combination with 5-azacitidine as post-remission therapy for acute myeloid leukaemia.". Wei A1, Tan P, Perruzza S, Govindaraj C, Fleming S, McManus J, Avery S, Patil S, Stevenson W, Plebanski M, Spencer A. Br J Haematol. 2015 Apr;169(2):199-210. doi: 10.1111/bjh.13281. Epub 2015 Feb 2.
Public notes

Contacts
Principal investigator
Name 31733 0
A/Prof Andrew Wei
Address 31733 0
Alfred Hospital
Commercial Road
Melbourne
VIC
3004
Country 31733 0
Australia
Phone 31733 0
+61 3 90763392
Fax 31733 0
Email 31733 0
[email protected]
Contact person for public queries
Name 14980 0
Nola Kennedy
Address 14980 0
Level 1, William Buckland building
The Alfred Hospital
Commercial Rd,
Prahran, Victoria. 3181
Country 14980 0
Australia
Phone 14980 0
+61 3 9076 2217
Fax 14980 0
Email 14980 0
[email protected]
Contact person for scientific queries
Name 5908 0
nola kennedy
Address 5908 0
Level 1, William Buckland building
The Alfred Hospital
Commercial Rd,
Prahran, Victoria. 3181
Country 5908 0
Australia
Phone 5908 0
+61 3 9076 2217
Fax 5908 0
Email 5908 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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