NCT01186809

Brief Summary

The purpose of the Phase IIA study are to:

  1. 1.define the safety profile
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 23, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 23, 2019

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

7.2 years

First QC Date

August 10, 2010

Results QC Date

June 20, 2017

Last Update Submit

January 17, 2019

Conditions

Hematologic Malignancies

Keywords

hematologic malignancies (excluding Chronic Myeloid Leukemia)

Outcome Measures

Primary Outcomes (1)

  • Safety Measures

    The occurrence of a grade 4 acute graft versus host disease (GVHD), judged to be related to the study medication. Grading and staging will be performed using the Glucksberg scale

    Clinical response was measured at 100 days after the completion of the cell therapy program.

Secondary Outcomes (1)

  • Efficacy Measures

    The clinical response will be registered at day +100 after the last Cytokine Induced Killer (CIK) cell infusion

Study Arms (1)

Cytokine Induced Killer

EXPERIMENTAL

Sequential Infusion of Unmanipulated Donor Lymphocytes and Cytokine Induced Killer (CIK)

Biological: in vitro expanded Cytokine Induced Killer (CIK) cells

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

Also known as: patients will be offered Cytokine Induced Killer(CIK) cells., Four combinations of escalating Cytokine Induced Killer (CIK) cells infusions will be provided, until the MTD will be defined., Combination 1st CIK cells infusion 2nd CIK cells infusion 3rd CIK cells infusion, 1 1x106/Kg 1x106/Kg 5x106/kg, 2 1x106/Kg 5x106/kg 5x106/kg, 3 1x106/Kg 5x106/kg 10x106/kg, 4 5x106/kg 5x106/kg 10x106/kg
Cytokine Induced Killer

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Azienda Ospedaliera Papa Giovanni XXIII (Former:Ospedali Riuniti di Bergamo) Bergamo

Bergamo, 24127, Italy

Location

Ospedale Centrale di Bolzano

Bolzano, Italy

Location

Ospedale San Gerardo

Monza, Italy

Location

Related Publications (4)

  • Introna M, Franceschetti M, Ciocca A, Borleri G, Conti E, Golay J, Rambaldi A. Rapid and massive expansion of cord blood-derived cytokine-induced killer cells: an innovative proposal for the treatment of leukemia relapse after cord blood transplantation. Bone Marrow Transplant. 2006 Nov;38(9):621-7. doi: 10.1038/sj.bmt.1705503. Epub 2006 Sep 18.

    PMID: 16980990RESULT

  • Introna M, Borleri G, Conti E, Franceschetti M, Barbui AM, Broady R, Dander E, Gaipa G, D'Amico G, Biagi E, Parma M, Pogliani EM, Spinelli O, Baronciani D, Grassi A, Golay J, Barbui T, Biondi A, Rambaldi A. Repeated infusions of donor-derived cytokine-induced killer cells in patients relapsing after allogeneic stem cell transplantation: a phase I study. Haematologica. 2007 Jul;92(7):952-9. doi: 10.3324/haematol.11132.

    PMID: 17606446RESULT

  • Capelli C, Salvade A, Pedrini O, Barbui V, Gotti E, Borleri G, Cabiati B, Belotti D, Perseghin P, Bellavita P, Biondi A, Biagi E, Rambaldi A, Golay J, Introna M. The washouts of discarded bone marrow collection bags and filters are a very abundant source of hMSCs. Cytotherapy. 2009;11(4):403-13. doi: 10.1080/14653240902960437.

    PMID: 19462317RESULT

  • Introna M, Pievani A, Borleri G, Capelli C, Algarotti A, Mico C, Grassi A, Oldani E, Golay J, Rambaldi A. Feasibility and safety of adoptive immunotherapy with CIK cells after cord blood transplantation. Biol Blood Marrow Transplant. 2010 Nov;16(11):1603-7. doi: 10.1016/j.bbmt.2010.05.015. Epub 2010 Jun 1.

    PMID: 20685246RESULT

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Cell Count

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesCell Physiological Phenomena

Results Point of Contact

Title
Prof Alessandro Rambaldi
Organization
Asst Papa Giovanni XXIII
arambaldi@asst-pg23.it
+390352673681

Study Officials

  • Alessandro AR Rambaldi, Professor

    Azienda Ospedaliera Papa Giovanni XXIII (Former:Ospedali Riuniti di Bergamo)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

August 10, 2010

First Posted

August 23, 2010

Study Start

July 1, 2009

Primary Completion

September 1, 2016

Study Completion

May 15, 2017

Last Updated

January 23, 2019

Results First Posted

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

final report

Locations

IT(3)