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

Trial: HOVON-associated CMV pp65 specific T-cells


News
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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News


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1. Overview



Summary

Treatment with CMV pp65‐specific T cells generated by use of a CMV pp65 protein‐spanning peptide pool in patients with CMV reactivation or CMV disease after allogeneic stem cell transplantation (alloSCT)


Status

open



Study details



Type of study

Prospective randomized Phase II study


Target number of patients

15


Study objectives

To assess the feasibility, tolerability and safety of administration of donor derived CMV pp65‐specific T cells in patients with CMV reactivation or CMV disease after alloSCT.
To determine the presence of CMV‐specific T cells at different time points after infusion of CMV pp65‐specific T cells.
To evaluate whether administration of CMV pp65‐specific T cells in patients with persistent CMV reactivation or CMV disease after alloSCT leads to complete or partial responses.


2. Patient eligibility criteria



Inclusion criteria

age 0‐75 years
recipient of alloSCT for standard indication according to national‐ and European Group for blood and Marrow Transplantation‐guidelines (see appendix D)
Possibility to obtain PBMC by leukapheresis from the CMV seropositive donor or availability of peripheral blood stem cell graft (PBSCT) or of a CD34‐negative subfraction of a CD34‐positively selected PBSCT product of the donor prepared and cryopreserved at a GMP‐facility or stem cell center.
CMV reactivation treatment failure (persistent CMV DNA load of more than 1000 cp/ml or CMV disease after 2 weeks of adequate treatment with antiviral therapy or relapse of CMV DNA load of more than 1000 cp/ml within 4 weeks after adequate treatment with antiviral therapy or contraindication for treatment with antiviral therapy at the discretion of the physician) or CMV disease (organ dysfunction (pneumonitis, enteritis, retinitis, encephalitis, hepatitis, and bone marrow suppression) due to CMV infection).
Written informed consent by the patient and/or parent(s) or legal guardian(s).


Exclusion criteria

Life expectation < 3 months.
End stage irreversible multi‐system organ failure.
Pregnant or lactating women.
Severe psychological disturbances.
Patient HIV positive.
Donor HIV positive.


3. Registration (& randomization) of patients



Registration

Registration is done by Ms. S. Kersting or Ms. F. Beaumont through email or phone (skersting@lumc.nl or mfbeaumont@lumc.nl or +31 (0)71 526 22 67)


Registration criteria

The following information will be requested:



Please send in the following by fax (+31 (0)71 526 67 55) or email:
Signed informed consent form
Results sero status patient and donor
Information regarding frozen cells
Results CMV assessment
And by mail:
Plasma and blood of the patient (for assessment imune status against CMV, and identification of patient)


4. Participating parties



Principal investigator

Dr. S. Kersting (skersting@lumc.nl)


Trial manager

Mw. M. F. Beaumont (mfbeaumont@lumc.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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