Status:
UNKNOWN
Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation
Lead Sponsor:
University of Sydney
Collaborating Sponsors:
Melbourne Health
Royal Brisbane and Women's Hospital
Conditions:
Acute Myeloid Leukaemia
Eligibility:
All Genders
Phase:
PHASE1
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 al...
Detailed Description
To determine the safety and tolerability of co-administration of partially HLA antigen matched unrelated donor cryopreserved donor lymphocytes (microtransplantation) with chemotherapy for patients wit...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02189824
Start Date
August 1 2014
Last Update
November 2 2015
Active Locations (1)
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1
Westmead Hospital Department of Haematology
Westmead, Sydney, New South Wales, Australia, 2145