Prophylactic Infusion of Donor Lymphocytes in Cord Blood Transplantation

Leukemia Clinical Trial

Official title:

Prophylactic Infusion of Donor Lymphocytes in Cord Blood Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02328885
• Other study ID #: I.2013.004
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 2014
• Est. completion date: March 22, 2017

Study information

• Verified date: December 2021
• Source: Banc de Sang i Teixits
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 22, 2017
• Est. primary completion date: March 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Leukemia

Intervention

Drug:
• DLI of the 20 fraction of the UCBT
Administration of 20 fraction of the UCBT

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital de Sant Pau	Barcelona
Spain	Hospital de Sant Pau	Barcelona
Spain	Hospital Vall Hebron	Barcelona
Spain	Hospital Universitari de Bellvitge	Hospitalet de Llobregat	Barcelona

Sponsors (6)

Lead Sponsor	Collaborator
Banc de Sang i Teixits	Fundacion IMIM, Germans Trias i Pujol Hospital, Hospital de Sant Pau, Hospital Universitari de Bellvitge, Hospital Vall d'Hebron

Country where clinical trial is conducted

Spain, 

References & Publications (44)

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* Note: There are 44 references in all — Click here to view all references

Outcome

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

External Links

•   Blood and Tissue Bank of Catalonia
•   Hospital de Sant Pau
•   Hospital Universitari de Bellvitge
•   Hospital Universitari Germans Trias i Pujol
•   Hospital Vall d'Hebron
•   Institut Hospital del Mar d'Investigacions Mèdiques