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

Myelodysplastic Syndromes Clinical Trial

— PRO-DLI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02856464
• Other study ID #: PRO-DLI
• Status: Recruiting
• Phase: Phase 2
• Start date: December 21, 2016
• Est. completion date: September 2020

Study information

• Verified date: April 2020
• Source: King's College Hospital NHS Trust
• Contact: Victoria Potter, BSc MBBS FRACP FRCPA PGCert
• Phone: +44 (0)20 3299 3730
• Email: victoriapotter[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes

Intervention

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)

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

Locations

Country	Name	City	State
United Kingdom	King's College Hospital NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival		One year