Prophylactic DLI for the Prevention of Relapse Post HSCT in Patients With High Risk Myeloid Malignancy
NCT ID: NCT02856464
Last Updated: 2020-04-02
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
PHASE2
124 participants
INTERVENTIONAL
2016-12-21
2020-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental
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)
Control
DLI will be administered from Month 6 (+/- 20 days) after stem cell transplant according to institutional practice
Interventions
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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)
DLI will be administered from Month 6 (+/- 20 days) after stem cell transplant according to institutional practice
Eligibility Criteria
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Inclusion Criteria
1. Acute Myeloid Leukaemia (AML) if Intermediate or High risk in CR1
2. AML if favourable risk in CR2
3. Patients with AML or MDS with residual cytogenetic or molecular disease pre-HSCT
4. CMML
5. 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
6. Secondary MDS or AML; defined as arising from antecedent haematological disease or secondary to prior chemotherapy.
2. Patients with sibling or 9/10 or 10/10 HLA matched unrelated donor
3. Patients receiving alemtuzumab based reduced intensity conditioned HSCT
4. Age \>/=18 years
5. Able to comprehend and give informed consent
Exclusion Criteria
2. Patients eligible for myeloablative (Bu/Cy of Cy/TBI) HSCT protocols
3. Patients with myelofibrosis
4. Patients with hypersensitivity to alemtuzumab, melphalan, fludarabine or busulphan
5. ECOG performance status \> 2
6. Patients who are pregnant or lactating
18 Years
ALL
No
Sponsors
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King's College Hospital NHS Trust
OTHER
Responsible Party
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Locations
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King's College Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Victoria Potter, BSc MBBS FRACP FRCPA PGCert
Role: primary
Other Identifiers
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PRO-DLI
Identifier Type: -
Identifier Source: org_study_id
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