Prophylactic DLI for the Prevention of Relapse Post HSCT... | NCT02856464

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

NCT02856464

Sponsor

King's College Hospital NHS Trust

Status

Unknown status

Last Update Posted

Apr 2, 2020Actual

Enrollment

124Estimated

Phase

Phase 2

Conditions

Myelodysplastic Syndromes
Leukemia, Myeloid, Acute

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

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 21, 2016Actual

Primary Completion Date

Sep 2020Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

Aug 2, 2016

First Submission Date that Met QC Criteria

Aug 2, 2016

First Posted Date

Aug 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2020

Last Update Posted Date

Apr 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

124Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Measure	Description	Time Frame
Disease free survival		One year

Eligibility Module

Eligibility Criteria

Patient Inclusion Criteria

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.
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Victoria Potter, BSc MBBS FRACP FRCPA PGCert	Contact	+44 (0)20 3299 3730		victoriapotter@nhs.net

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King's College Hospital NHS Foundation Trust	Recruiting	London		SE5 9RS	United Kingdom

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D009190	Myelodysplastic Syndromes
D015470	Leukemia, Myeloid, Acute