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Clinical picture: Benign

Trial: HOVON 134 MF


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

A Phase II, single arm multicenter trial, using pacritinib pretreatment in patients with myelofibrosis (primary, post-ET or post PV-MF) before allo-SCT.
The improvement of SCT outcome will be investigated. SCT outcome will be studied at 180 days post SCT, defining SCT failure as the occurrence of primary graft failure, secondary graft failure, the occurrence of grade 3-4 GvHD or death.


Status

planned


Members

HOVON



Study details



Echelon level

Level A


Echelon level specification

Allo transplantation centers


Type of monitoring for this study

Site evaluation visits


Target number of patients

70


Study objectives

Primary Objective:
Improve allo-SCT transplant outcome using a uniform conditioning regimen and pacritinib pretreatment by means of the proportion of patients with a failure within 6 months post-transplant. Events that are considered a failure are: primary graft failure; secondary graft failure; acute GvHD grade 3-4; death whatever the cause is

Secondary objectives
• To assess the effect of pacritinib treatment on splenomegaly
• To improve disease response by pacritinib treatment and allo-SCT as defined by the IWG-MRT response criteria
• To determine the proportion of patients receiving allo-SCT
• To document safety and toxicity of pacritinib treatment before allo-SCT
• To compare the effect of the treatment on marrow fibrosis by DCE-MRI scan at study entry, before SCT and 6 months post-SCT and bone marrow biopsy
• To evaluate efficacy of induction therapy determined as time to response
• To determine time to red cell recovery (red blood cell transfusion incidence for >4 weeks) after SCT
• To determine progression free survival and overall survival from study inclusion and separately from allo-SCT in transplanted patients
• To evaluate NRM (Non-Relapse -Mortality) from inclusion and separately after allo-SCT in transplanted patients
• To determine effects on JAK2, calreticulin or mpl (allelic) burden before and after allo-SCT (allelic burden before pacritinib treatment, at conditioning and monthly 1-4, 6 and 12 months post SCT) and donor (micro) chimerism
• To summarize Quality-of-Life (QOL) during/after treatment using the MPN-SAF scoring tool
• To determine effects on inflammatory cytokines at study entry, before start conditioning and 3 and 6 months after allo-SCT
• To determine the prognostic value of additional molecular markers ( ASXL1, TET2, SRSF2, DNMT3A, EZH2, CBL, IDH1,2, Lnk, SF3B1)


2. Patient eligibility criteria



Inclusion criteria

• Patients with a confirmed diagnosis of post-ET, post-PV or primary myelofibrosis (Appendix A)
• Intermediate-2 or high-risk according to DIPSS plus (Appendix F)
• Age 18-70 years inclusive
• WHO performance status 0-2 (Appendix C)
• All men and women of childbearing potential must agree to use adequate contraception during the study
• Written informed consent
• Patient is capable of giving informed consent


Exclusion criteria

• Previous treatment with JAK2 inhibitors within 2 weeks of study inclusion. Patients who have been treated with pacritinib as their previous JAK2 inhibitor treatment cannot participate in this study.
• Any GI or metabolic condition that could interfere with absorption of oral medication
• Severe cardiac dysfunction (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease);
• Experimental treatment within four weeks before inclusion for PMF, Post-PV, or Post-ET MF
• Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D)
• Significant hepatic dysfunction (total bilirubin ≥ 30 μmol/l or transaminases ≥ 3 times normal level, unless disease-related)
• Severe neurological or psychiatric disease
• Severe renal impairment (creatinine clearance < 40 ml/min)
• Patients with active, uncontrolled infections
• Patients known to be HIV(human immunodeficiency virus)-positive
• Active hepatitis A, B or C
• History of active malignancy during the past 3 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
• Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.)
• Pregnant or breastfeeding women
• Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule


3. Registration (& randomization) of patients



Registration

Eligible patients should be registered before start of treatment. Patients need to be registered at the HOVON Data Center by one of the following options:
• Trial Online Process (TOP, https://www.hdc.hovon.nl/top). A logon to TOP can be requested at the HOVON Data Center for participants.
• By faxing the completed registration/randomization CRF +31.10.7041028 Monday through Friday, from 09:00 to 17:00 CET
• By phone +31.10.7041560 Monday through Friday, from 09:00 to 17:00 CET


Registration criteria

The following information will be requested:



The following information will be requested at registration:
• Protocol number
• Institution name
• Name of caller/responsible investigator
• Sex
• Age on inclusion and year of birth
• Date written informed consent
• Specific items patient gives consent for (see ICF)
• Eligibility criteria


4. Participating parties



Principal investigator

dr. P. te Boekhorst


Trial manager

J. Refos (j.refos@erasmusmc.nl)


Central data management

CTC


5. Participating sites



6. Instruction videos



7. Download documentation / forms




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