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Prophylactic Infusion of Donor Lymphocytes in Cord Blood Transplantation

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ClinicalTrials.gov Identifier: NCT02328885
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : July 3, 2018
Sponsor:
Collaborators:
Hospital Vall d'Hebron
Hospital de Sant Pau
Hospital Universitari de Bellvitge
Germans Trias i Pujol Hospital
Fundacion IMIM
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Leukemia Other: DLI of the 20 fraction of the UCBT Phase 1 Phase 2

Detailed Description:
Multicenter, open-label, single-arm, phase I-II pilot study in which a mínimum 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 reconstituation followed by a new platform of treatment consisting of initial cord blood unit 80 fraction transplantation, followed by a prophylactic donor lymphocite infusion (DLI) of the fraction 20 of the cord blood unit. The second infusion will take place between 60 and 90 days after transplantation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prophylactic Infusion of Donor Lymphocytes in Cord Blood Transplantation
Actual Study Start Date : July 2014
Actual Primary Completion Date : March 22, 2017
Actual Study Completion Date : March 22, 2017

Arm Intervention/treatment
Experimental: Experimental
DLI of the 20 fraction of the UCBT
Other: DLI of the 20 fraction of the UCBT
Administration of 20 fraction of the UCBT




Primary Outcome Measures :
  1. Safety of this therapeutic approach as determined by clinical evaluation of the immediate effects of the infusion & Analysis of the GVHD post-DLI [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Efficacy of this therapeutic approach as determinated by analysis of the speed and diversity of immune reconstitution [ Time Frame: 1 year ]
  2. Efficacy of this therapeutic approach as determinated by analysis of the incidence and type of infections [ Time Frame: 1 year ]
  3. Efficacy of this therapeutic approach as determinated by analysis of the incidence of relapse [ Time Frame: 1 year ]
  4. Efficacy of this therapeutic approach as determinated by analysis of the therapeutic success of transplantation using survival curves [ Time Frame: 1 year ]


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Ages Eligible for Study:   up to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328885


Locations
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Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Universitari de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital de Sant Pau
Barcelona, Spain, 08025
Hospital Vall Hebron
Barcelona, Spain, 08035
Hospital de Sant Pau
Barcelona, Spain, 08041
Sponsors and Collaborators
Banc de Sang i Teixits
Hospital Vall d'Hebron
Hospital de Sant Pau
Hospital Universitari de Bellvitge
Germans Trias i Pujol Hospital
Fundacion IMIM
Investigators
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Principal Investigator: Sergio Querol, PhD Banc de Sang i Teixits
Additional Information:
Publications:

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Responsible Party: Banc de Sang i Teixits
ClinicalTrials.gov Identifier: NCT02328885    
Other Study ID Numbers: I.2013.004
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Banc de Sang i Teixits:
high-risk acute leukemia
graft versus leukemia
DLI
UCBT
Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms