NCT02942173

Brief Summary

The purpose of this prospective randomized study is to determine whether infusions of T-memory cells prevent infections in children with leukemia after allogeneic alpha, beta T-cell receptor (TcRab)/CD19-depleted hematopoietic stem cell transplantation (HSCT).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2 leukemia

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2020

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

2.9 years

First QC Date

October 11, 2016

Last Update Submit

March 15, 2023

Conditions

LeukemiaLymphomaMyelodysplastic SyndromesGvHDOpportunistic InfectionsGraft-versus-Host Disease

Keywords

CD45RA-depletionTCR-alpha/beta depletionHematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (2)

  • cumulative incidence of the probability of CMV-reactivation after HSCT

    120 days after HSCT

  • cumulative incidence of acute GVHD grade II-IV.

    150 days after HSCT

Secondary Outcomes (7)

  • cumulative incidence of of CMV-disease at 100,180 and 365 days after HSCT

    100, 180 and 365 days after HSCT

  • overall survival at 365 days after HSCT

    365 days after HSCT

  • Event-free survival at 365 days after HSCT

    365 days after HSCT

  • cumulative incidence of relapse at 6 months and 365 days after HSCT

    6 months and 365 days

  • cumulative incidence of transplant-related mortality at 6 months after HSCT

    6 months

  • +2 more secondary outcomes

Study Arms (2)

CD45RA-

NO INTERVENTION

CD45RA+

EXPERIMENTAL
Biological: CD45RA-depleted peripheral blood mononuclear cells

Interventions

CD45RA-depleted peripheral blood mononuclear cellsBIOLOGICAL

Infusion of escalating doses of CD45RA-depleted donor-derived allogeneic peripheral blood mononuclear cells

CD45RA+

Eligibility Criteria

AgeUp to 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients who are considered candidates for allogeneic hematopoietic stem cell transplantation and have one of the following diagnoses:
  • Acute lymphocytic leukemia (ALL)
  • Acute myeloid leukemia
  • Acute biphenotypic leukemia
  • Acute bilinear leukemia
  • Lymphoma
  • Myelodysplastic syndrome
  • Chronic myeloid leukemia
  • Transplant processing: TCR ab/CD19-depletion
  • Donors:
  • HLA-match unrelated volunteers
  • Partly and haploidentical relative

You may not qualify if:

  • ALL patients not in remission
  • Patients with uncontrolled infections
  • Clearance of creatinine \< 70 ml/min
  • Cardiac ejection fraction \< 40%
  • Patients who can perform pulmonary function tests will be excluded if they have a diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) of \< 50% predicted; patients who are unable to perform pulmonary function tests will be excluded if the oxygen (O2) saturation is \< 92% on room air
  • Patients who have liver function test (LFTs) (including total bilirubin, aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]) \>= twice the upper limit of normal
  • Mental disease of both patient, patient's tutor (if patient is under age 18) and donor, that hinder understanding of main point of the study and keeping treatment plan, hygiene and sanitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal Research Center for pediatric hematology, oncology and immunology

Moscow, 117997, Russia

Location

MeSH Terms

Conditions

LeukemiaLymphomaMyelodysplastic SyndromesOpportunistic InfectionsGraft vs Host Disease

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Marrow DiseasesInfections

Study Officials

  • Michael Maschan, PhD

    Fedaral Research Center for pediatric hematology, oncology and immunology

    STUDY DIRECTOR

  • Larisa Shelikhova, PhD

    Fedaral Research Center for pediatric hematology, oncology and immunology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 21, 2016

Study Start

October 1, 2016

Primary Completion

August 21, 2019

Study Completion

August 21, 2020

Last Updated

March 16, 2023

Record last verified: 2023-03

Locations

RU(1)