Prophylactic Infusion of Donor Lymphocytes in Cord Blood Transplantation
- Conditions
- Leukemia
- Interventions
- Drug: DLI of the 20 fraction of the UCBT
- Registration Number
- NCT02328885
- Lead Sponsor
- Banc de Sang i Teixits
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
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
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental DLI of the 20 fraction of the UCBT DLI of the 20 fraction of the UCBT
- Primary Outcome Measures
Name Time Method Safety assessment 1 year Adverse events
- Secondary Outcome Measures
Name Time Method Immune reconstitution: 1 year Subpopulations of Lymphocytes T: CD4 and CD8
Infections in treated patients 1 year Incidence of infections
Survival curves 1 year Global and disease-free survival
Mortality 1 year Incidence of early and late mortality
Immune regeneration 1 year Lymphocytes B
Immunological reconstitution: 1 year NK cells
Relapse of leukemia 1 year Incidence of relapse
Infections in the treated patients 1 year Type of infections
Trial Locations
- Locations (4)
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital de Sant Pau
🇪🇸Barcelona, Spain
Hospital Vall Hebron
🇪🇸Barcelona, Spain
Hospital Universitari de Bellvitge
🇪🇸Hospitalet de Llobregat, Barcelona, Spain