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

NCT02856464 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2020-04-02

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • King's College Hospital NHS Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-21
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02856464 on ClinicalTrials.gov