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

Trial: HOVON-associated Anti-CD20 cGVHD 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


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1. Overview



Summary

Anti-CD20 therapy for the treatment of chronic graft versus host disease


Status

closed



Type of study

Prospective Phase II study


Target number of patients

50


Study objectives

To study prospectively the clinical efficacy of Rituximab treatment in combination with the PDGF inhibitor Nilotinib of steroid refractory chronic GVHD


2. Patient eligibility criteria



Inclusion criteria

Age ≥ 18 years
Chronic GVHD, including skin localization, refractory or dependent to first line treatment consisting of steroids and/or ciclosporine. Refractory cGVHD is defined as progressive cGVHD after at least 2 weeks of first line treatment or no response after 4 weeks of first line treatment. Dependent cGVHD is defined as an inability to taper immunosuppressive treatment.
Written informed consent
WHO performance status ≤ 2


Exclusion criteria

Relapse and a life expectancy of < 6 months
Life expectancy of < 6 months
Systemic infections: active viral infections, including HIV
Other treatment for GVHD apart from steroids, ciclosporine and, when applicable, standard GVHD prevention
Previous treatment with Rituximab and / or TKIs.
Inadequate renal and liver function, i.e. creatinin or bilirubin >2.5 x the upper normal value
Neutrophil count <1.5 x 10^9/L and hemoglobin level <6.2 mmol/l, thrombocyte count < 75 x 10^9/L
Pregnant or lactating
History of pancreatitis
Any experimental therapy within 30 days prior to randomization
Known sensitivity or allergy to murine products
Known impaired cardiac function, including any of the following:
LVEF < 45%
Complete left bundle branch block
Right bundle branch block plus left anterior hemiblock, bifascicular block
Use of a ventricular-paced pacemaker
Congenital long QT syndrome
History of or presence of clinically significant ventricular or atrial tachyarrhythmias
Clinically significant resting bradycardia (< 50 beats per minute)
QTcF >450 msec on screening ECG. If QTcF > 450 msec and electrolytes are not
within normal ranges before nilotinib dosing, electrolytes should be corrected and
then the patient rescreened for QTcF criterion.
Myocardial infarction within 12 months prior to starting nilotinib
Other clinical significant heart disease (e.g. unstable angina, congestive heart failure,
uncontrolled hypertension)
Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent


3. Registration (& randomization) of patients



4. Participating parties



Principal investigator

Dr. J.H.E. Kuball, MD PhD


Coordinating investigator(s)

Drs. L.C.J. te Boome, MD


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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