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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON-associated SADAL trial (Protocol KCP-330-009)


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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News


No news


1. Overview



Summary

A Phase-2b Open-label, randomized Two-arm Study comparing high and low doses of selinexor (KPT-330) in patients with relpased/refractory Diffuse large B-cell Lymphoma (DLBCL).


Status

open


Members

VUmc Amsterdam - J.M. Zijlstra
LUMC Leiden - J.S.P. Vermaat


Type of study

Prospective randomized Phase II study


Echelon level

Level A


Type of monitoring for this study

Study specific


Target number of patients

200


Date of activation

01-Sep-2016


Approved by

METC VUmc Amsterdam


Change history / amendement

No


Study objectives

To evaluate the efficacy of Selinexor 100 mg oral dose twice weekly versus 60 mg oral dose twice weekly.


2. Patient eligibility criteria



Inclusion criteria

• R/R DLBCL (GCB/ non-GCB/ DH-DLBCL); transformed FL
• Tenminste 2, maximaal 5, eerdere lijnen, w.o. Antracyclines en Rituximab
• Life expectancy > 3 months
• Tenminste 14 weken na laatste systemische therapie


Exclusion criteria

• PMBCL
• CNS disease


3. Registration (& randomization) of patients



4. Participating parties



5. Participating sites



6. Instruction videos



7. Download documentation / forms




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