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

Trial: HOVON-associated PLMA25 NK-cell study

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

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PLMA25 news

This study is now closed for new registration.

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

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.


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


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.


New procedure for logistics HLA tests



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


1. Overview


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)




UMC Sint Radboud

Study details

Target number of patients


Date of activation


Approved by


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


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

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

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:

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


geen documenten in deze categorie

 plma25 flyer_mar14

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