Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation
SCRAMBLE
2 other identifiers
interventional
12
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2014
CompletedFirst Posted
Study publicly available on registry
July 15, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedNovember 2, 2015
October 1, 2015
2.3 years
July 11, 2014
October 29, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of acute graft versus host disease within 60 days of completion of final infusion of donor lymphocytes
60 days
Secondary Outcomes (3)
Duration of post chemotherapy cytopenias
60 days
Remission rate
12 months
Duration of complete remission
12 months
Study Arms (1)
Infusion of partially matched unrelated donor cells
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Newly diagnosed AML not considered suitable for allogenic stem cell transplant on the basis of age or co-morbidities
- Complete morphological remission following 1-2 cycles of induction chemotherapy consisting of an anthracycline/cytosine arabinoside combination
- Availability of cryopreserved donor stem cells or bone marrow with appropriate HLA matching
- Adequate hepatic and renal function
- Estimated life expectancy of at least 6 months
- 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
You may not qualify if:
- Patient not in morphological remission following 2 cycles of induction chemotherapy
- 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
- Absence of a cryopreserved donor stem cell or bone marrow product with appropriate matching
- Presence of significant hepatic, renal or other major organ dysfunction
- Uncontrolled infection or bleeding prior to commencement of consolidation chemotherapy
- Privately insured in or outpatient on the day the consent is signed and the days that cryopreserved partially HLA matched donor cells are infused
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sydneylead
- Melbourne Healthcollaborator
- Royal Brisbane and Women's Hospitalcollaborator
Study Sites (1)
Westmead Hospital Department of Haematology
Westmead, Sydney, New South Wales, 2145, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2014
First Posted
July 15, 2014
Study Start
August 1, 2014
Primary Completion
December 1, 2016
Last Updated
November 2, 2015
Record last verified: 2015-10