Prophylactic Infusion of Donor Lymphocytes in Cord Blood Transplantation

December 3, 2021 updated by: Banc de Sang i Teixits
Pilot, multicentric, open-label, single-arm, phase I-II clinical trial to evaluate the safety and efficacy of a novel Umbilical Cord Blood Transplantation (UCBT) platform, that consists of a UCBT of the 80 fraction, followed by a Donor Lymphocyte Infusion (DLI) of the 20 fraction (between 60 and 90 days after transplantation).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Multicenter, open-label, single-arm, phase I-II pilot study in which a minimum of 20 patients will enter the study with the primary objective to assess the safety and secondary objective to assess efficacy in relation to immune reconstitution followed by a new platform of treatment consisting of initial cord blood unit 80 fraction transplantation, followed by a prophylactic donor lymphocyte infusion (DLI) of the fraction 20 of the cord blood unit. The second infusion will take place between 60 and 90 days after transplantation.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Hospital de Sant Pau
      • Barcelona, Spain, 08035
        • Hospital Vall Hebron
      • Barcelona, Spain, 08041
        • Hospital de Sant Pau
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

At the time of transplantation:

  • Patients under 60 years with proposal UCBT according to assistance protocol
  • Diagnosis of high-risk acute leukemia with an indication of allogenic transplantation
  • Frozen UCB bag split into two bags: one with the 80% of the product and another with the 20%
  • Presence of at least 1.2E9 total nucleated cells and> 1E5 CD34 / kg and> 6E6 CD34 + in fraction 80%
  • 4/6 or better compatibility taking Human Leukocyte Antigen (HLA) HLA-A, HLA-B by antigenic resolution and DRB1 by allelic resolution
  • The patient (or legal representative if required) has signed the informed consent

At the time of DLI:

  • Documented cord blood engraftment
  • The patient has had no Graft Versus Host Disease (GVHD) during the first 60 days post-transplantation or, if present, receives less than 10 milligrams of prednisone at the time of the DLI or <0.2 mg / kg / day of prednisone for pediatric patients (<16 years).
  • The patient has less than 200 CD4 + cells per microliter on peripheral blood at 60 days (± 7 days) post-transplantation
  • The patient (or legal representative if required) has signed the informed consent

Exclusion Criteria:

At the time of transplantation:

  • Simultaneous participation in another clinical trial or treatment with other research phase product within 30 days prior to inclusion in the study.
  • Pregnant women or those who intend to become pregnant within 12 months after the signing of the informed consent or not taking proper contraceptive measures according to investigator criteria.
  • Breastfeeding women
  • Other pathologies or circumstances that may compromise the patient's participation in the study according to the criteria of the investigator.

At the time of DLI:

  • Grade III-IV GVHD after allogeneic UCB
  • Prednisone treatment (> 10 mg total per day in adults or> 0.2 mg / kg / day prednisone for pediatric patients)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
DLI of the 20 fraction of the UCBT
Drug: DLI of the 20 fraction of the UCBT
Administration of 20 fraction of the UCBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety assessment
Time Frame: 1 year
Adverse events
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune reconstitution:
Time Frame: 1 year
Subpopulations of Lymphocytes T: CD4 and CD8
1 year
Immunological reconstitution:
Time Frame: 1 year
NK cells
1 year
Immune regeneration
Time Frame: 1 year
Lymphocytes B
1 year
Infections in treated patients
Time Frame: 1 year
Incidence of infections
1 year
Infections in the treated patients
Time Frame: 1 year
Type of infections
1 year
Relapse of leukemia
Time Frame: 1 year
Incidence of relapse
1 year
Survival curves
Time Frame: 1 year
Global and disease-free survival
1 year
Mortality
Time Frame: 1 year
Incidence of early and late mortality
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Banc de Sang i Teixits

Collaborators

Germans Trias i Pujol Hospital
Hospital Universitari de Bellvitge
Hospital Vall d'Hebron
Fundacion IMIM
Hospital de Sant Pau

Investigators

  • Principal Investigator: Sergio Querol, PhD, Banc de Sang i Teixits

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

March 22, 2017

Study Completion (Actual)

March 22, 2017

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

December 30, 2014

First Posted (Estimate)

December 31, 2014

Study Record Updates

Last Update Posted (Actual)

December 8, 2021

Last Update Submitted That Met QC Criteria

December 3, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I.2013.004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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