Prophylactic Infusion of Donor Lymphocytes in Cord Blood Transplantation

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Prophylactic Infusion of Donor Lymphocytes in Cord Blood Transplantation

Conditions
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Leukemia

Intervention / Treatment
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* Drug: DLI of the 20 fraction of the UCBT


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: DLI
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>DLI of the 20 fraction of the UCBT | Drug: DLI of the 20 fraction of the UCBT<br>* Administration of 20 fraction of the UCBT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment | Adverse events | 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high-risk acute leukemia, graft versus leukemia, DLI, UCBT