Prophylactic CD45RA-depleted DLI After Haploidentical Tra... | NCT05066412

Studies
Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC

NCT05066412

Sponsor

University Hospital, Geneva

Status

Recruiting

Last Update Posted

Feb 13, 2025Actual

Enrollment

12Estimated

Phase

Phase 1

Conditions

Hematologic Malignancy
Haplo-identical Stem Cell Transplantation

Interventions

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

Countries

Switzerland

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 26, 2024Actual

Primary Completion Date

Jun 2, 2026Estimated

Completion Date

Dec 2, 2026Estimated

First Submitted Date

Jul 9, 2021

First Submission Date that Met QC Criteria

Oct 1, 2021

First Posted Date

Oct 4, 2021Actual

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

Feb 10, 2025

Last Update Posted Date

Feb 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Primary Objective is to determine whether the administration of prophylactic CD45RAneg (CD45RAneg) memory/effector T lymphocytes is feasible and safe in the early post-transplant period for patients with haploidentical transplant and RIC conditioning.

Donor lymphocytes are isolated from the original donor by non-mobilized mononuclear cell leukapheresis. Repetitive intravenous infusions (up to 3) of escalating doses of CD45RAneg cells, prepared from the leukapheresis by CliniMACS® technology (CD45RA-depletion), storage in vapor nitrogen.

Escalating doses of CD45RAneg cells, for patients with haploidentical graft, intervals of 6-8 weeks, if GvHD is absent starting ≥ 4 weeks from the day of transplantation.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Prophylactic CD45RA-depleted DLI	Other: CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology	Other	CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)
Hematologic or molecular relapse of the primary malignancy requiring chemotherapy or unmanipulated DLI (receiving prophylactic antileukemic agent, eg TKI, is not an exclusion criteria)
Donor aberrant CD45RA expression due to a polymorphism in CD45 gene
Participation in another interventional clinical trial within 30 days prior to inclusion
Pregnant or nursing women. Sexually active women with childbearing potential as well as sexually active male patients who are unwilling to use an effective method of contraception during participation in the study from time of inclusion until 2 months after last dose of CD45RAneg DLI infusion
Inability to follow the procedures of the study, including, but not limited to, language problems, psychological disorders, dementia

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

Name	Role	Phone	Extension	Email
Anne-Claire Mamez	Contact	+41786656487		anne-claire.mamez@hcuge.ch

Facility	Status	City	State	ZIP	Country	Contacts
HUG	Recruiting	Geneva	Canton of Geneva	1205	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases