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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02189824




Registration number
NCT02189824
Ethics application status
Date submitted
11/07/2014
Date registered
15/07/2014
Date last updated
1/11/2015

Titles & IDs
Public title
Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation
Scientific title
Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation
Secondary ID [1] 0 0
PG1061252
Secondary ID [2] 0 0
SCTL141501
Universal Trial Number (UTN)
Trial acronym
SCRAMBLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukaemia 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Infusion of partially matched unrelated donor cells -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of acute graft versus host disease within 60 days of completion of final infusion of donor lymphocytes
Timepoint [1] 0 0
60 days
Secondary outcome [1] 0 0
Duration of post chemotherapy cytopenias
Timepoint [1] 0 0
60 days
Secondary outcome [2] 0 0
Remission rate
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Duration of complete remission
Timepoint [3] 0 0
12 months

Eligibility
Key inclusion criteria
1. Newly diagnosed AML not considered suitable for allogenic stem cell transplant on the basis of age or co-morbidities
2. Complete morphological remission following 1-2 cycles of induction chemotherapy consisting of an anthracycline/cytosine arabinoside combination
3. Availability of cryopreserved donor stem cells or bone marrow with appropriate HLA matching
4. Adequate hepatic and renal function
5. Estimated life expectancy of at least 6 months
6. Patient has given informed consent or in the event of a patient not able to give informed consent, consent has been given according to hospital procedures in force at the time of trial
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient not in morphological remission following 2 cycles of induction chemotherapy
2. Use of fludarabine or other purine analogue during remission induction or use of any major immunosuppressive medication or any other immunomodulatory agent including thalidomide, lenalidomide, or azacitidine immediately prior to concurrent with administration of chemotherapy for AML or during or in the 3 months after administration of partially HLA matched 3rd party cells
3. Absence of a cryopreserved donor stem cell or bone marrow product with appropriate matching
4. Presence of significant hepatic, renal or other major organ dysfunction
5. Uncontrolled infection or bleeding prior to commencement of consolidation chemotherapy
6. Privately insured in or outpatient on the day the consent is signed and the days that cryopreserved partially HLA matched donor cells are infused

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital Department of Haematology - Westmead, Sydney
Recruitment postcode(s) [1] 0 0
2145 - Westmead, Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Melbourne Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Royal Brisbane and Women's Hospital
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A phase 1 study of infusion of partially HLA matched unrelated donor blood or marrow cells (microtransplantation) following consolidation chemotherapy in patients with AML that are not suitable for allogenic stem cell transplantation.
Trial website
https://clinicaltrials.gov/study/NCT02189824
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Emily Blyth
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02189824