sluit venster

Log in

Gebruikersnaam Wachtwoord Gebruikersnaam en/of wachtwoord vergeten? Gebruikersnaam en wachtwoord aanvragen

Zoek in de HOVON website

Let op!
Mogelijk ziet u niet alle beschikbare info op deze pagina, omdat u niet bent ingelogd, of omdat u niet de juiste privileges heeft.

Clinical picture: SCT (Stem Cell Transplantation and Cellular Therapies)

Trial: HOVON-associated PLMA25 NK-cell study


News
1. Overview
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


return to top

News


PLMA25 news

28-09-2015
This study is now closed for new registration.


11-03-2014
In collaboration with Glycostem Therapeutics the inclusion of the PLMA25 is re-opened.


03-10-2013
The PLMA25 study is temporary on hold. At this moment preparations are taken to continue the study under the complete authorization of the department of hematology and the laboratory of hematology of the Radboudumc. According to expectations the study will be opened again for inclusion in January 2014.


29-05-2013

Changes in procedures regarding safety. Administration of G-CSF is documented. Possible requirement of blood transfusion is described in patient information letter.

 

19-07-2012
Change of eligibility criterium: Patients have not to be homozygous for the HLA-Cw group. Also patients heterozygous for this group are now candidate for the study.


18-07-2012

New procedure for logistics HLA tests

 

09-02-2012

Adjustment of eligibility criteria:

- Change of inclusion criterium: Age of inclusion >= 55 years of age not eligible for SCT.

- Addition of exclusion criterium: Presence of HLA antibodies.

 

Current number of patients

10



1. Overview



Summary

Infusion of ex vivo-cultured allogeneic NK cells in acute myeloid leukemia patients not eligible for stem cell transplantation (a phase I dose escalation study)


Status

closed


Members

UMC Sint Radboud



Target number of patients

15


Date of activation

31-May-2011


Approved by

CCMO


Study objectives

Primary objective:
Evaluation of safety and toxicity of allogenic NK cell infusions with an escalating dose up to 10*10^7/kg body weight ex vivo-expanded NK cells following immunosuppressive conditioning therapy in patients with AML.

Secondary objectives:
Evaluation of the in vivo lifespan of the expanded NK cells following adoptive transfer.
Exploration of the biological and clinical activity of NK cell infusion in study participants.


2. Patient eligibility criteria



Inclusion criteria

AML patients >=55 year of age not eligible for SCT
Absence of HLA antibodies
CR after first line standard chemotherapy
CR after second line chemotherapy
WHO performance 0-1 (see appendix 3 of the protocol)
Life expectancy > 6 months
Written informed consent


Exclusion criteria

Patients candidates for SCT
Progressive disease, no change or only minor response following induction and consolidation therapy
Patients on immunosuppressive drugs
Patients with active infections (viral, bacterial or fungal) that requires specific therapy. Acute anti-infectious therapy must have been completed within 14 days prior to study treatment
Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease (see appendix 2 of the protocol)
Severe pulmonary dysfunction (CTCAE III-IV) (see appendix 2 of the protocol)
Severe renal dysfunction (serum creatinine > 3 times normal level) (see appendix 2 of the protocol)
Severe hepatic dysfunction (serum bilirubin or transaminases > 3 times normal level) (see appendix 2 of the protocol)
Severe neurological or psychiatric disease
Presence of HLA antibodies


3. Registration (& randomization) of patients



Registration

For clinical questions and registration of patients you can contact dr. N. Schaap, clinical coordinator of the study by phone number 024-3614762 or mail address immunotherapie@hemat.umcn.nl.

For questions about HLA tests (HLA typing and HLA antibodies) see the “Frequently Asked Questions” in paragraph 6 of this publication. For other questions regarding immunology or HLA typing you can contact dr. H. Dolstra, laboratory coordinator of the study by phone numer 024-3613223 or mail address immunotherapie@hemat.umcn.nl.

For other correspondence please contact:

UMC Sint Radboud
Department of Hematology
476 Trial & Data Center
P.O. Box 9101
6500 HB Nijmegen
Phone number: 024-3614794
Fax number: 024-3668205
Mail address: immunotherapie@hemat.umcn.nl


Registration criteria

The following information will be requested:



This is a non-HOVON study. The registration program TOP will not be used.


4. Participating parties



Principal investigator

Dr. N. Schaap


Coordinating investigator(s)

Dr. H. Dolstra
Dr. F. Preijers
Dr. J. Spanholtz
Prof. Dr. N. Blijlevens
Prof. dr. T. de Witte
Dr. A. van der Meer
Prof. dr. I. Joosten
B. Ruiterkamp
Drs. M. Roeven


Trial manager

Drs. O. Huber
Ing. B. van Haren


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol

geen documenten in deze categorie

 plma25 flyer_mar14



return to top