Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation

Study Overview
=================
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.

Official Title
-----------------
Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation

Conditions
-----------------
Acute Myeloid Leukaemia

Intervention / Treatment
-----------------
* Biological: Partially HLA-matched unrelated donor cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infusion of partially matched unrelated donor cells<br> | Biological: Partially HLA-matched unrelated donor cells<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute graft versus host disease within 60 days of completion of final infusion of donor lymphocytes |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of post chemotherapy cytopenias |  | 60 days | 
| Remission rate |  | 12 months | 
| Duration of complete remission |  | 12 months |