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

King's College Hospital NHS Trust

Status and phase: Unknown; Phase 2

Conditions: Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Treatments: Other: DLI will be administered from Month 6 (+/- 20 days) after stem cell transplant according to institutional practice; 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)

Study type: Interventional

Funder types: Other

Identifiers

NCT02856464

PRO-DLI

Details and patient eligibility

About

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patient Inclusion Criteria

1. Haematological cancer which can be one of the following

   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

Patient Exclusion Criteria

1. Patients with >5% blasts at time of HSCT
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Experimental

Experimental group

Treatment:

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)

Control

Other group

Treatment:

Other: DLI will be administered from Month 6 (+/- 20 days) after stem cell transplant according to institutional practice