NCT02337595

Brief Summary

The stud will evaluate whether infusions of CD45RA-depleted lymphocytes from the donor early post-transplant is a safe way to improve immunity to common infections in recipients of TCR-alpha/beta depleted hematopoietic stem cell grafts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2014

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

August 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 22, 2016

Status Verified

April 1, 2016

Enrollment Period

7 months

First QC Date

January 9, 2015

Last Update Submit

April 21, 2016

Conditions

Precursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteImmune Deficiency DiseaseBone Marrow Failure SyndromesOpportunistic InfectionsGraft vs Host Disease

Keywords

CD45RA-depletionTCR-alpha/beta depletionHematopoietic Stem Cell Transplantationimmune reconstitutionGraft Enhancement, ImmunologicImmunocompromized Host

Outcome Measures

Primary Outcomes (2)

  • Cumulative incidence of grade 2-4 acute graft-versus-host disease

    Cumulative incidence (competing risk model) of acute graft-versus-host disease

    100 days

  • Immune reconstitution (Quantitative evaluation of lymphocyte subsets in the peripheral blood, quantitative evaluation of pathogen-specific immune response by ELISPOT assay)

    Quantitative evaluation of lymphocyte subsets in the peripheral blood, quantitative evaluation of pathogen-specific immune response by ELISPOT assay

    120 days

Secondary Outcomes (3)

  • 1-year survival

    1 year

  • Transplant-related mortality

    1-year

  • Incidence of chronic graft-versus-host disease

    1 year

Interventions

CD45RA-depleted peripheral blood mononuclear cellsBIOLOGICAL

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

Eligibility Criteria

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

You may qualify if:

  • recipient of allogeneic hematopoietic stem cell graft from haploidentical or matched unrelated donor
  • TCR alpha/beta depletion of the hematopoietic stem cell graft
  • CMV-seropositive donor
  • stable hematopoietic engraftment

You may not qualify if:

  • active graft-versus-host disease grade 2-4
  • any systemic immune suppressive therapy except calcineurin inhibitor monotherapy
  • uncontrolled sepsis

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

Related Publications (2)

  • Teschner D, Distler E, Wehler D, Frey M, Marandiuc D, Langeveld K, Theobald M, Thomas S, Herr W. Depletion of naive T cells using clinical grade magnetic CD45RA beads: a new approach for GVHD prophylaxis. Bone Marrow Transplant. 2014 Jan;49(1):138-44. doi: 10.1038/bmt.2013.114. Epub 2013 Aug 12.

    PMID: 23933765BACKGROUND

  • Bleakley M, Heimfeld S, Jones LA, Turtle C, Krause D, Riddell SR, Shlomchik W. Engineering human peripheral blood stem cell grafts that are depleted of naive T cells and retain functional pathogen-specific memory T cells. Biol Blood Marrow Transplant. 2014 May;20(5):705-16. doi: 10.1016/j.bbmt.2014.01.032. Epub 2014 Feb 11.

    PMID: 24525279BACKGROUND

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteImmune Deficiency DiseaseBone Marrow Failure DisordersOpportunistic InfectionsGraft vs Host Disease

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, MyeloidBone Marrow DiseasesInfections

Study Officials

  • Michael Maschan, MD

    Fedaral Research Center for pediatric hematology, oncology and immunology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2015

First Posted

January 13, 2015

Study Start

August 1, 2014

Primary Completion

March 1, 2015

Study Completion

January 1, 2016

Last Updated

April 22, 2016

Record last verified: 2016-04

Locations

RU(1)