Phase 2 N=73 Treatment

Cytokine Induced Killer (CIK) Cells In Leukemia Patients

Hematologic Malignancies

Bottom Line

View on ClinicalTrials.gov: NCT01186809 ↗

Enrolled (actual)

Serious AEs

11.0%

Results posted

Jan 2019

Primary outcome: Primary: Safety Measures — 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: in vitro expanded Cytokine Induced Killer (CIK) cells (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: A.O. Ospedale Papa Giovanni XXIII
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety Measures	—	—
SECONDARY Efficacy Measures	—	—

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.

Eligibility Criteria

Inclusion Criteria

Patients with haematologic malignancies (excluding chronic myeloid Leukemia- CML) with a molecular, cytogenetic or haematologic relapse after allogeneic transplantation.
Patients with an available donor willing to donate peripheral blood lymphocytes
Immunosuppression must be withdrawn at the beginning of the cell therapy program
Written informed consent prior to any study procedures being performed

Exclusion Criteria

Donors positive for HIV, HBV or HCV, or unfit to undergo leukapheresis
Patients with active acute or chronic Graft versus host disease (GvHD)
Patients with rapidly progressive disease or not controlled by palliative supportive treatments including chemotherapy and with a life expectancy less than 8 weeks
Patients with severe psychiatric illness or any disorder that compromises ability to give truly informed consent for participation in this study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01186809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.