Prophylactic DLI for the Prevention of Relapse Post HSCT in Patients With High Risk Myeloid Malignancy

Study Overview
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Brief Summary
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The trial will be conducted as a multicentre open label, randomised prospective phase II clinical trial in patients with high risk myeloid malignancies. The primary objective is to evaluate whether prophylactic donor lymphocyte infusions (DLI) delivered as part of a planned schedule improves the disease free survival of patients with myeloid malignancies.

Official Title
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A Phase II Prospective Trial of Prophylactic Donor Lymphocyte Infusions for the Prevention of Relapse Post HSCT in Patients With High Risk Myeloid Malignancy

Conditions
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Myelodysplastic Syndromes, Leukemia, Myeloid, Acute

Intervention / Treatment
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* Other: DLI will be administered to all patients at Month 4 (+/- 20 days) after stem cell transplant regardless of peripheral blood CD3 chimerism (including if they have full donor chimerism)
* Other: DLI will be administered from Month 6 (+/- 20 days) after stem cell transplant according to institutional practice


Participation Criteria
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Eligibility Criteria
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Patient Inclusion Criteria Haematological cancer which can be one of the following Acute Myeloid Leukaemia (AML) if Intermediate or High risk in CR1 AML if favourable risk in CR2 Patients with AML or MDS with residual cytogenetic or molecular disease pre-HSCT CMML Myelodysplastic Syndrome (MDS) defined by an IPSS category int-1 or higher with <5% blasts at the time of randomisation following cyto-reduction if necessary Secondary MDS or AML; defined as arising from antecedent haematological disease or secondary to prior chemotherapy. Patients with sibling or 9/10 or 10/10 HLA matched unrelated donor Patients receiving alemtuzumab based reduced intensity conditioned HSCT Age >/=18 years Able to comprehend and give informed consent Patient Exclusion Criteria Patients with >5% blasts at time of HSCT Patients eligible for myeloablative (Bu/Cy of Cy/TBI) HSCT protocols Patients with myelofibrosis Patients with hypersensitivity to alemtuzumab, melphalan, fludarabine or busulphan ECOG performance status > 2 Patients who are pregnant or lactating

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br> | Other: DLI will be administered to all patients at Month 4 (+/- 20 days) after stem cell transplant regardless of peripheral blood CD3 chimerism (including if they have full donor chimerism)<br> <br> |
| Other: Control<br> | Other: DLI will be administered from Month 6 (+/- 20 days) after stem cell transplant according to institutional practice<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | One year |