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Status unknownNCT02856464PRO-DLIUpdated Apr 2, 2020

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

A Phase 2 interventional study of 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) and DLI will be administered from Month 6 (+/- 20 days) after stem cell transplant according to institutional practice in Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, sponsored by King's College Hospital NHS Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-02.

Sponsored by King's College Hospital NHS Trust · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Myelodysplastic Syndromes
  • Leukemia, Myeloid, Acute
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In context

Myelodysplastic Syndromes

2,165 studies on the registry are indexed under Myelodysplastic Syndromes; 322 are open to participants now.

This study's planned enrollment of 124 is above the median of 39 across 1,771 interventional studies indexed under Myelodysplastic Syndromes.

Browse Myelodysplastic Syndromes studies →

Lead sponsor

King's College Hospital NHS Trust is the lead sponsor of 171 studies on the registry; 56 are open to participants now.

Browse King's College Hospital NHS Trust studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
124 participants (estimated)

Study arms

  • 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)

  • Other
    Control

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

Interventions

  • OtherDLI 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)
  • OtherDLI will be administered from Month 6 (+/- 20 days) after stem cell transplant according to institutional practice
06

What researchers measure

Primary outcomes

  1. Disease free survival

    Time frame: One year

07

Study locations

1 of 1 sites recruiting
  • King's College Hospital NHS Foundation Trust
    London, SE5 9RS, United Kingdom
    • Victoria Potter, BSc MBBS FRACP FRCPA PGCert · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02856464
Lead sponsor
King's College Hospital NHS Trust
Responsible party
Sponsor
First posted
Aug 4, 2016
Start date
Dec 21, 2016
Primary completion
Sep 2020 (estimated)
Completion
Sep 2020 (estimated)
Last update
Apr 2, 2020

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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