Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC

NCT05066412 | Recruiting Phase 1

• 1 other identifier: Cd45RA depleted DLI
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

To assess safety of prophylactic escaladed dose of T naïve depleted (CD45RA depleted donor lymphocyte infusion, in patients with malignant hemopathie who received an allogeneic stem cell transplant from an haplo-identical donor, after a reduced intensity conditionning regiment.

Conditions

Hematologic Malignancy; Haplo-identical Stem Cell Transplantation

Outcome Measures

Primary Outcomes (2)

• acute transfusion reaction (CTCAE ≥ 2)

  acute transfusion reaction after each DLI infusion (CTCAE ≥ 2)

  24 hours after each CD45RA neg DLI infusion

• acute GvHD grade II-IV

  acute GvHD grade II-IV measured with MAGIC score

  within 8 weeks after each CD45RAneg DLI infusion

Study Arms (1)

Arm 1

EXPERIMENTAL

Prophylactic CD45RA-depleted DLI

Other: CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology

Interventions

CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology OTHER

CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology

Arm 1

Eligibility Criteria

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

You may qualify if:

• Patients who received a stem cell graft from a haploidentical donor after RIC for hematologic malignancies
• Written informed consent of patient and donor obtained

You may not qualify if:

• Participant taking Prednisone (or equivalent steroid)
• Participant taking Prednisone (or equivalent steroid)
• Participant taking Mycophenolate Mofetil
• Participant taking Cyclosporine/tacrolimus at therapeutic blood levels
• Progressive hematologic malignancy before transplant
• Second allogeneic transplant
• Acute GvHD ≥ grade 2
• Chronic moderate or severe GvHD (NIH consensus criteria)
• Donor aberrant CD45RA expression due to a polymorphism in CD45 gene
• Inability to follow the procedures of the study, including, but not limited to, language problems, psychological disorders, dementia

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

HUG

Geneva, Canton of Geneva, 1205, Switzerland

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Anne-Claire Mamez

CONTACT

+41786656487; anne-claire.mamez@hcuge.ch

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: October 4, 2021
• Study Start: November 26, 2024
• Primary Completion (Estimated): June 2, 2026
• Study Completion (Estimated): December 2, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)