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

Trial: HOVON-associated Innate allo-SCT


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


Innate allo-SCT news

Mainz will be the second center that is participating in the Innate allo-SCT study.

 

Please find the protocol behind the login.


1. Overview



Summary

Towards a novel immune therapy platform with an innate allogeneic haematopoietic stem cell transplantation in patients with haematological malignancies.


Status

open



Study details



Type of study

Prospective Phase II study


Target number of patients

35


Study objectives

Primary Objective:
To implement an T-cell depleted stem cell transplantation as low-GVHD platform in order to increase the number of patients eligible for further immune interventions from day 100.
Secondary Objective:
To address all other clinical transplantation-related parameters and immunological reconstitution after an T-cell depleted stem cell transplantation.


2. Patient eligibility criteria



Inclusion criteria

Adults (> 18 years)
Haematological malignancies eligible for allo-SCT according to the policy of the local centre
WHO performance status ≤ 2
Written informed consent


Exclusion criteria

Relapse of allo-SCT within 5 months after allo-SCT
Bilirubin and/or transaminases > 2.5 x normal value
Creatinine clearance < 40 ml/min
Cardiac dysfunction as defined by:
- Unstable angina
- Unstable cardiac arrhythmias
Active, uncontrolled infection


3. Registration (& randomization) of patients



Registration

Register new patient through UMCU


Registration criteria

The following information will be requested:



inclusion and exclusion criteria


4. Participating parties



Principal investigator

J. Kuball, MD Professor (j.h.e.kuball@umcutrecht.nl)


Coordinating investigator(s)

M.A. de Witte , MD, PhD
L. van de Wagen, MD


Other functions

Processing of cellular products:
I.C.M. Slaper-Cortenbach (islaper@umcutrecht.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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