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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02856464

Acronym

PRO-DLI

Enrollment

124

Registered

2016-08-04

Start date

2016-12-21

Completion date

2020-09-30

Last updated

2020-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

Brief summary

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.

Interventions

OTHERDLI 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)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Disease free survival	One year

Countries

United Kingdom

Contacts

Primary ContactVictoria Potter, BSc MBBS FRACP FRCPA PGCert

victoriapotter@nhs.net+44 (0)20 3299 3730

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026