Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12613000337774
Ethics application status
Approved
Date submitted
25/02/2013
Date registered
27/03/2013
Date last updated
25/05/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
Pilot Study of partially Human Leucocyte Antigen (HLA)-mismatched stem cell infusions after chemotherapy for acute myeloid leukaemia in patients over the age of 60.
Query!
Scientific title
Pilot Study of partially Human Leucocyte Antigen (HLA)-mismatched stem cell infusions after chemotherapy for acute myeloid leukaemia in patients over the age of 60: an evaluation of incidence of Graft vs Host Disease and treatment related mortality.
Query!
Secondary ID [1]
281995
0
Nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukaemia > 60 yrs
288431
0
Query!
Condition category
Condition code
Blood
288780
288780
0
0
Query!
Haematological diseases
Query!
Cancer
289033
289033
0
0
Query!
Leukaemia - Acute leukaemia
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Infusion of Granulocyte Colony Stimulating Factor (G-CSF) mobilised Peripheral Blood Stem Cells (PBSCs) from a partially HLA-mismatched relative after standard induction and consolidation chemotherapy for patient with Acute Myeloid Leukaemia greater than 60 yrs of age.
PBSCs will be harvested by apheresis from the donor on day 9 (of induction chemotherapy for the patient) after administration of GCSF to the donor(10 micrograms/kg subcutaneously daily from days 5 to 8). The minimum stipulated CD34 positive cell dose will be greater than 0.5 x 10^6/kg. The total collection will be divided into 4 aliquots: 3 portions will be cryopreserved for later use and one portion will be infused into patient on the day of collection (day 9).
Induction therapy will consist of 7+3 regimen with continuous Cytarabine (150mg/m2) intravenous infusion for 7 days and Mitoxantrone (10mg/m2) intravenously daily for 3 days, followed by intravenous infusion of GCSF mobilised PBSCs on day 9. Bone marrow biopsy will be performed by day 28 +/- 7 days and if complete remission is confirmed patients will proceed with consolidation chemotherapy. If patient is not in morphologic complete remission then a further cycle of induction followed by PBSC infusion is offered.
If the patient is in remission following induction, 2 cycles of consolidation chemotherapy, comprising the 5 + 2 regimen (Mitoxantrone 10mg/m2 IV days 1 to 2 and Cytarabine 150mg/m2 continuous IV infusion days 1 to 5) will be delivered and each cycle will be followed by IV infusion of PBSCs, 36 to 48 hours after chemotherapy has been disconnected.
All of the above treatments are part of the study intervention.
Query!
Intervention code [1]
286566
0
Treatment: Other
Query!
Intervention code [2]
286804
0
Treatment: Drugs
Query!
Comparator / control treatment
Uncontrolled
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
288916
0
Cumulative incidence of Graft vs Host Disease assessed clinically every week during treatment phase and then at study time points (every third month for two years).
Query!
Assessment method [1]
288916
0
Query!
Timepoint [1]
288916
0
3, 6, 9, 12, 15, 18, 21 and 24 months
Query!
Primary outcome [2]
289106
0
Treatment Related Mortality defined as death in remission or related to the treatment, including PBSC infusion.
Query!
Assessment method [2]
289106
0
Query!
Timepoint [2]
289106
0
6 months
Query!
Secondary outcome [1]
301330
0
Rate of complete remission (CR) following induction chemotherapy assessed using morphological assessment of bone marrow aspirate and defined as less than 5% blasts.
Query!
Assessment method [1]
301330
0
Query!
Timepoint [1]
301330
0
assessed at Day 28
Query!
Secondary outcome [2]
301331
0
Time to neutrophil and Platelet recovery following chemotherapy assessed using daily full blood counts.
Query!
Assessment method [2]
301331
0
Query!
Timepoint [2]
301331
0
post each treatment cycle
Query!
Secondary outcome [3]
301332
0
Number of blood products infused by collecting records of packed red blood cell and platelet transfusions for each patient.
Query!
Assessment method [3]
301332
0
Query!
Timepoint [3]
301332
0
Day 28 of each treatment cycle
Query!
Secondary outcome [4]
301333
0
Severe infection rate following induction chemotherapy assessed clinically and with microbiological, radiological investigations during patient care.
Query!
Assessment method [4]
301333
0
Query!
Timepoint [4]
301333
0
Day 28
Query!
Secondary outcome [5]
301334
0
Duration of first remission, defined as time from achieving Complete Remission to Relapse (diagnosed clinically, with a full blood count and bone marrow biopsy), Death from other causes or end of followup.
Query!
Assessment method [5]
301334
0
Query!
Timepoint [5]
301334
0
year 1 and year 2
Query!
Secondary outcome [6]
301335
0
Overall and leukaemia free survival. Overall Survival is defined as time to death and Leukaemia free survival is defined as time from achieving CR to relapse or death.
Query!
Assessment method [6]
301335
0
Query!
Timepoint [6]
301335
0
year 1 and Year 2
Query!
Secondary outcome [7]
301336
0
Rate of detectable donor chimerism measured using DNA Short Tandem Repeat (STR) based testing on bone marrow samples.
Query!
Assessment method [7]
301336
0
Query!
Timepoint [7]
301336
0
Day 28 of each treatment cycle
Query!
Eligibility
Key inclusion criteria
Patients aged over 60 with previously untreated AML undergoing induction chemotherapy, who have an available partially HLA-mismatched donor
Query!
Minimum age
60
Years
Query!
Query!
Maximum age
85
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Patient with Acute Promyelocytic Leukaemia, Chronic Myeloid Leukaemia or unfit for induction chemotherapy or have immunodeficiency (apart from neutropenia)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients over the age of 60 years presenting with previously untreated AML. Patients with Acute Promyelocytic Leukaemia (APmL) or Chronic Myeloid Leukaemia in Blast Crisis (CML-BC) will not be eligible as there are specific targeted therapies for these conditions. The intended donor is a partially HLA-mismatched relative defined as HLA-haploidentity at HLA-A, -B, -C, and –DRB1. In most cases this would mean a biological child, although siblings and grandchildren also have a 50% chance of HLA-haploidentity. Donors must fulfill eligibility criteria as per standards published by BMT Network NSW.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
No data analysis planned
Query!
Reason for early stopping/withdrawal
Participant recruitment difficulties
Query!
Date of first participant enrolment
Anticipated
30/11/2012
Query!
Actual
30/11/2012
Query!
Date of last participant enrolment
Anticipated
10/01/2015
Query!
Actual
8/04/2013
Query!
Date of last data collection
Anticipated
1/12/2015
Query!
Actual
Query!
Sample size
Target
12
Query!
Accrual to date
Query!
Final
4
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
635
0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Query!
Recruitment postcode(s) [1]
6368
0
2010 - Darlinghurst
Query!
Funding & Sponsors
Funding source category [1]
286774
0
Hospital
Query!
Name [1]
286774
0
St Vincent's Hospital, Sydney
Query!
Address [1]
286774
0
390 Victoria St
Darlinghurst NSW 2010
Query!
Country [1]
286774
0
Australia
Query!
Primary sponsor type
Hospital
Query!
Name
St Vincent's Hospital, Sydney
Query!
Address
390 Victoria St
Darlinghurst NSW 2010
Query!
Country
Australia
Query!
Secondary sponsor category [1]
285571
0
None
Query!
Name [1]
285571
0
Query!
Address [1]
285571
0
Query!
Country [1]
285571
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
288839
0
St Vincent's Hospital Human Research Ethics Committee
Query!
Ethics committee address [1]
288839
0
390 Victoria St
Darlinghurst NSW 2010
Query!
Ethics committee country [1]
288839
0
Query!
Date submitted for ethics approval [1]
288839
0
29/05/2012
Query!
Approval date [1]
288839
0
31/07/2012
Query!
Ethics approval number [1]
288839
0
HREC/12/SVH/141
Query!
Summary
Brief summary
This study aims to determine the effect of partially HLA-mismatched stem cell infusions after chemotherapy for acute myeloid leukaemia in older patients.
Who is it for? You may be eligible to join this study if you are aged between 60-85 years and have been diagnosed with acute myeloid leukaemia (AML) which has been previously untreated. You should be undergoing induction chemotherapy and have an available partially HLA-mismatched donor.
Trial details: All participants in this trial will undergo standard induction chemotherapy. Peripheral blood stem cells (PBSCs) will be collected from the available donor, then harvested and administered to the patient on day 9 of induction chemotherapy by intravenous infusion (i.e. directly into the vein). On day 28 a bone marrow biopsy will be performed, and if complete remission is confirmed then patients will proceed with two cycles of consolidation chemotherapy. If the patient is not in complete remission then a further cycle of induction chemotherapy followed by PBSC infusion is offered. Participants will be regularly assessed for up to 24 months in order to determine clinical efficacy and safety of the treatment.
Query!
Trial website
Query!
Trial related presentations / publications
nil publications,
Query!
Public notes
Query!
Contacts
Principal investigator
Name
38022
0
Dr Sam Milliken
Query!
Address
38022
0
Kinghorn Cancer Centre
St Vincent's Hospital, sydney
370 Victoria St
Darlinghurst NSW 2010
Query!
Country
38022
0
Australia
Query!
Phone
38022
0
61 2 9355 5656
Query!
Fax
38022
0
61 2 9355 5735
Query!
Email
38022
0
[email protected]
Query!
Contact person for public queries
Name
38023
0
Ms Patricia Plenge
Query!
Address
38023
0
Kinghorn Cancer Centre
St Vincent's Hospital, sydney
370 Victoria St
Darlinghurst NSW 2010
Query!
Country
38023
0
Australia
Query!
Phone
38023
0
61 2 9355 5613
Query!
Fax
38023
0
61 2 9355 5735
Query!
Email
38023
0
[email protected]
Query!
Contact person for scientific queries
Name
38024
0
Dr Sam Milliken
Query!
Address
38024
0
Kinghorn Cancer Centre
St Vincent's Hospital, sydney
370 Victoria St
Darlinghurst NSW 2010
Query!
Country
38024
0
Australia
Query!
Phone
38024
0
61 2 9355 5656
Query!
Fax
38024
0
61 2 9355 5735
Query!
Email
38024
0
[email protected]
Query!
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.
Download to PDF