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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
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
Trial website
Trial related presentations / publications
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
andrew.wei@monash.edu
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
n.kennedy@alfred.org.au
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
n.kennedy@alfred.org.au

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.