Clinical trial NCT02189824: Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation
Official title: Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Acute Myeloid Leukaemia
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: Melbourne Health
name: Royal Brisbane and Women's Hospital
First posted: 2014-07-15
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 with high risk acute myeloid leukaemia ineligible or unsuitable for high dose chemotherapy and stem cell transplantation.

Eligibility criteria: 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

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

Primary outcomes:
measure: Incidence of acute graft versus host disease within 60 days of completion of final infusion of donor lymphocytes
timeFrame: 60 days
Secondary outcomes:
measure: Duration of post chemotherapy cytopenias
timeFrame: 60 days
measure: Remission rate
timeFrame: 12 months
measure: Duration of complete remission
timeFrame: 12 months
Other outcomes:
Locations:
city: Westmead, Sydney
country: Australia
facility: Westmead Hospital Department of Haematology
state: New South Wales
Study officials:
References: