Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation (SCRAMBLE)
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ClinicalTrials.gov Identifier: NCT02189824
Recruitment Status : Unknown
Verified October 2015 by University of Sydney. Recruitment status was: Recruiting
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.
To determine the safety and tolerability of co-administration of partially HLA antigen matched unrelated donor cryopreserved donor lymphocytes (microtransplantation) with chemotherapy for patients with high risk acute myeloid leukaemia ineligible or unsuitable for high dose chemotherapy and stem cell transplantation.
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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