CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 74 enrolled
Drug / intervention
in vitro expanded Cytokine Induced Killer (CIK) cellsbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01186809
NCT01186809Phase 2Completed
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Sequential Infusion of Unmanipulated Donor Lymphocytes and Cytokine Induced Killer (CIK)Cells After Allogeneic Stem Cell Transplantation

A.O. Ospedale Papa Giovanni XXIII·interventional·Posted Aug 23, 2010·Updated Jan 23, 2019

In Brief

A Phase 2 clinical trial evaluating in vitro expanded Cytokine Induced Killer (CIK) cells for Hematologic Malignancies. Completed, enrolled 74 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematologic Malignancies
CountriesItaly
CollaboratorsRegional Hospital of Bolzano, Azienda Ospedaliera San Gerardo di Monza

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 23, 2010
Enrollment StartJul 1, 2009
Primary CompletionSep 1, 2016
Study CompletionMay 15, 2017
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 15.9 years ago

Interventions

in vitro expanded Cytokine Induced Killer (CIK) cellsbiological

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