Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation
NCT ID: NCT02189824
Last Updated: 2015-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
12 participants
INTERVENTIONAL
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Infusion of partially matched unrelated donor cells
Partially HLA-matched unrelated donor cells
Interventions
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Partially HLA-matched unrelated donor cells
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
ALL
No
Sponsors
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Melbourne Health
OTHER
Royal Brisbane and Women's Hospital
OTHER_GOV
University of Sydney
OTHER
Responsible Party
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Locations
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Westmead Hospital Department of Haematology
Westmead, Sydney, New South Wales, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PG1061252
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SCTL141501
Identifier Type: -
Identifier Source: org_study_id
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