NCT02856464

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: King's College Hospital NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Myelodysplastic Syndromes
• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-12-21
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2016-08-04
• Last updated: 2020-04-02

Locations

1 site across 1 country: United Kingdom