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

NCT02856464 | Unknown Phase 2 DMC

• 1 other identifier: PRO-DLI
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  One year

Study Arms (2)

Experimental

EXPERIMENTAL

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

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

Interventions

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

Experimental

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Haematological cancer which can be one of the following
• Acute Myeloid Leukaemia (AML) if Intermediate or High risk in CR1
• AML if favourable risk in CR2
• Patients with AML or MDS with residual cytogenetic or molecular disease pre-HSCT
• CMML
• 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
• Secondary MDS or AML; defined as arising from antecedent haematological disease or secondary to prior chemotherapy.
• Patients with sibling or 9/10 or 10/10 HLA matched unrelated donor
• Patients receiving alemtuzumab based reduced intensity conditioned HSCT
• Age \>/=18 years
• Able to comprehend and give informed consent

You may not qualify if:

• Patients with \>5% blasts at time of HSCT
• Patients eligible for myeloablative (Bu/Cy of Cy/TBI) HSCT protocols
• Patients with myelofibrosis
• Patients with hypersensitivity to alemtuzumab, melphalan, fludarabine or busulphan
• ECOG performance status \> 2
• Patients who are pregnant or lactating

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Victoria Potter, BSc MBBS FRACP FRCPA PGCert

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 4, 2016
• Study Start: December 21, 2016
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 2, 2020

Record last verified: 2020-04

Locations

GB (1)