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Cytokine Induced Killer (CIK) Cells In Leukemia Patients

NCT01186809 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2019-01-23

Study results available
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Summary

The purpose of the Phase IIA study are to:

1. define the safety profile
2. evaluate the efficacy of a sequential infusion of unmanipulated Donor Lymphocyte Infusions (DLI) and Cytokine Induced Killer (CIK) cells for the treatment of molecular, cytogenetic or hematologic relapse after hematopoietic stem cell transplantation and The progression free survival and the overall survival after the sequential infusion of Donor Lymphocyte Infusions (DLI) and Cytokine Induced Killer(CIK) cells.

Conditions

Interventions

BIOLOGICAL

in vitro expanded Cytokine Induced Killer (CIK) cells

Three infusions of donor Cytokine Induced Killer (CIK) cells will be administered according to a dose escalating program, starting 3 weeks after second Donor Lymphocyte Infusions (DLI). Cytokine Induced Killer administrations will be separated by 3 weeks intervals

Sponsors & Collaborators

  • Regional Hospital of Bolzano

    collaborator OTHER

  • Azienda Ospedaliera San Gerardo di Monza

    collaborator OTHER

  • A.O. Ospedale Papa Giovanni XXIII

    lead OTHER

Principal Investigators

  • Alessandro AR Rambaldi, Professor · Azienda Ospedaliera Papa Giovanni XXIII (Former:Ospedali Riuniti di Bergamo)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2016-09-30
Completion
2017-05-15

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01186809 on ClinicalTrials.gov