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

• Sponsor: King's College Hospital NHS Trust (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02856464
• Collaborator: (none)
• Enrollment: 124
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 44.4
• Patients Per Site Per Month: 2.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes; Leukemia, Myeloid, Acute	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: DLI will be administered from Month 6 (+/- 20 days) after stem cell transplant according to institutional practice	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 21, 2016
• Anticipated Primary Completion Date: Sep 1, 2020
• Anticipated Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Disease free survival [One year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Patient Inclusion Criteria

1. Haematological cancer which can be one of the following

2. Acute Myeloid Leukaemia (AML) if Intermediate or High risk in CR1

3. AML if favourable risk in CR2

4. Patients with AML or MDS with residual cytogenetic or molecular disease pre-HSCT

5. CMML

6. 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

7. Secondary MDS or AML; defined as arising from antecedent haematological disease or secondary to prior chemotherapy.

8. Patients with sibling or 9/10 or 10/10 HLA matched unrelated donor

9. Patients receiving alemtuzumab based reduced intensity conditioned HSCT

10. Age >/=18 years

11. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King's College Hospital NHS Foundation Trust	London		United Kingdom	SE5 9RS

Sponsors and Collaborators

• King's College Hospital NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: King's College Hospital NHS Trust
• ClinicalTrials.gov Identifier: NCT02856464
• Other Study ID Numbers: PRO-DLI
• First Posted: Aug 4, 2016
• Last Update Posted: Apr 2, 2020
• Last Verified: Apr 1, 2020

• Additional relevant MeSH terms: Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Study Results

No Results Posted as of Apr 2, 2020