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

Trial: HOVON-associated TARGET study


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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1. Overview



Summary

Individualized dosing of fludarabine during innate allo SCT: A randomized phase II study


Status

open


Members

NL-LUMC
DE-Mainz



Study details



Type of study

Prospective Phase II study


Echelon level

Level A


Type of monitoring for this study

Study specific


Target number of patients

98


Date of activation

01-Jan-2019


Date closed

01-Jan-2021


Approved by

Medisch Ethische Toetsingscommissie UMC Utrecht


Study objectives

Main study parameters/endpoints:
Primary Endpoint:
Cumulative incidence of severe viral infections at day 100.
Secondary Endpoints:
Non relapse mortality (NRM) at day 100
aGVHD grade II-IV at day 100
Donor engraftment (chimerism > 95%) at day 100
Overall survival at day 100
Cumulative incidence of relapse at day 100
Effective fludarabine exposure


2. Patient eligibility criteria



Inclusion criteria

Adults (> 18 years)
AML, MDS, ALL, CML, CLL, NHL, HL, or a myeloproliferative disease (MPD)
Indication for allo-SCT according to the policy of the local center
WHO performance status ≤ 2
Written informed consent


Exclusion criteria

Relapse of disease within 5 months after previous allo-SCT
Bilirubin and/or transaminases > 2.5 x normal value*
Creatinine clearance < 40 ml/min*
Cardiac dysfunction as defined by:
- Unstable angina or unstable cardiac arrhythmias
- NYHA classification > II (Appendix B)
- Cardiac symptoms and/or history of cardiac disease AND a cardiac ejection fraction < 45%
Active, uncontrolled infection

*Assessed < 2 weeks prior to allo-SCT


3. Registration (& randomization) of patients



Registration

Register new patient through UMCU


4. Participating parties



5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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