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

Primary Purpose

Myelodysplastic Syndromes, Leukemia, Myeloid, Acute

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
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
Sponsored by
King's College Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King's College Hospital NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental

Control

Arm Description

Outcomes

Primary Outcome Measures

Disease free survival

Secondary Outcome Measures

Full Information

First Posted
August 2, 2016
Last Updated
April 1, 2020
Sponsor
King's College Hospital NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02856464
Brief Title
Prophylactic DLI for the Prevention of Relapse Post HSCT in Patients With High Risk Myeloid Malignancy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 21, 2016 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes, Leukemia, Myeloid, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Title
Control
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
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)
Intervention Type
Other
Intervention Name(s)
DLI will be administered from Month 6 (+/- 20 days) after stem cell transplant according to institutional practice
Primary Outcome Measure Information:
Title
Disease free survival
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patient Inclusion Criteria 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 Patient Exclusion Criteria 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Potter, BSc MBBS FRACP FRCPA PGCert
Phone
+44 (0)20 3299 3730
Email
victoriapotter@nhs.net
Facility Information:
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Potter, BSc MBBS FRACP FRCPA PGCert

12. IPD Sharing Statement

Learn more about this trial

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

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