Leukemia
Conditions
Keywords
high-risk acute leukemia, graft versus leukemia, DLI, UCBT
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.
Interventions
DRUGDLI of the 20 fraction of the UCBT
Administration of 20 fraction of the UCBT
Sponsors
Hospital Vall d'Hebron
Hospital de Sant Pau
Hospital Universitari de Bellvitge
Germans Trias i Pujol Hospital
Fundacion IMIM
Banc de Sang i Teixits
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
DLI
Eligibility
Sex/Gender
ALL
Age
No minimum to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessment | 1 year | Adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunological reconstitution: | 1 year | NK cells |
| Immune regeneration | 1 year | Lymphocytes B |
| Infections in treated patients | 1 year | Incidence of infections |
| Immune reconstitution: | 1 year | Subpopulations of Lymphocytes T: CD4 and CD8 |
| Relapse of leukemia | 1 year | Incidence of relapse |
| Survival curves | 1 year | Global and disease-free survival |
| Mortality | 1 year | Incidence of early and late mortality |
| Infections in the treated patients | 1 year | Type of infections |
Countries
Spain
Outcome results
None listed