Early Prophylactic Donor Lymphocyte Infusion After Allo-HSCT for Patients With AML

NCT03597321 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: ELIT-AML01-IPC 2017-006
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is a curative option for patients with acute myeloid leukemia (AML). However, transplantation related toxicity and mortality as well as the existence of HLA identical sibling donor represent major limitations. Over the 20 past years, the development of reduced intensity conditioning (RIC) regimen and the use of alternative donors allowed extending the possibility of Allo-HSCT for AML, with decreased toxicity and mortality. This invited to propose this strategy to more advanced patients, making that AML recurrence has become one of the main issues after Allo-HSCT. Thus, to develop prophylactic and preemptive strategies to minimize disease recurrence after Allo-HSCT is now the main challenge in the field. Among cellular and/or pharmacological treatments after Allo-HSCT, donor lymphocyte infusion (DLI) is probably one of the most commonly used treatments after Allo-HSCT. Indeed, DLI were reported as a potential efficient immunotherapy more than 20 years ago for the treatment of patients with leukemia relapsing after Allo-HSCT. However, most of experiences were reported in the setting of relapse after Allo-HSCT and no prospective evaluation of prophylactic DLI is available so far. Thus no strong recommendation for the use of DLI after Allo-HSCT can be made. Our study proposal would like to assess the question of prophylactic DLI efficacy, as a proof of concept of early immune intervention after Allo-HSCT. The investigators, therefore, designed a prospective multicenter randomized trial evaluating the impact of early DLI on outcome after Allo-HSCT for AML.

Conditions

Acute Myeloid Leukemia

Keywords

Allogeneic hematopoietic stem cell transplantation; donor lymphocyte infusion

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival (RFS) at 2 years after randomization

  RElpase-free survival will be evaluated in an intent-to-treat analysis by Kaplan Meier estimate and Log Rank test. Survival will be calculated from the date of randomization

  2 years

Study Arms (2)

Arm A-DLI

EXPERIMENTAL

Patients will be planned to receive prophylactic Donor Lymphocyte Injection

Biological: prophylactic donor lymphocyte infusion (DLI)

Arm B- No intervention

NO INTERVENTION

Interventions

prophylactic donor lymphocyte infusion (DLI) BIOLOGICAL

DLI will be collected from the donor by leukapheresis according to local standard procedures of each center. Cell product could be collected in one time or more, and administered fresh or after a frozen storage, according to each center's guidelines. A sufficient amount of T-cell dose should be collected to theoretically perform 3 DLI. DLI procedure will be performed according to local guidelines of each center.

Arm A-DLI

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age from 18 to 70.
• Able to comply with the protocol.
• Written informed consent.
• Allogeneic stem cell transplantation from any donor except cord blood.
• Unmanipulated bone marrow or peripheral blood stem cells as graft source are allowed

You may not qualify if:

• Presence or history of grade 2 to 4 acute GVHD.
• Pregnancy/breast feeding.
• Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
• Concomitant uncontrolled disease and/or organ dysfunction (infection, severe heart, renal, respiratory or hepatic failure…).
• Primary or secondary graft failure.
• Previous solid organ allogeneic transplantation.

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli-Calmettes

Marseille, Bouches Du Rhône, 13009, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

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

Study Officials

• Raynier Devillier, MD,PhD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

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: July 16, 2018
• First Posted: July 24, 2018
• Study Start: September 7, 2020
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 15, 2025

Record last verified: 2025-05

Locations

FR (1)