Endoplasmic Reticulum Stress and Resistance to Treatments in Ph-negative Myeloproliferative Neopl… (NCT02823184) | Clinical Trial Compass
CompletedNot Applicable
Endoplasmic Reticulum Stress and Resistance to Treatments in Ph-negative Myeloproliferative Neoplasms
France148 participantsStarted 2017-04-27
Plain-language summary
The aim of this study is to evaluate the endoplasmic reticulum stress markers as predictive for response to hydroxyurea in polycythemia vera (PV) and essential thrombocythemia (ET).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ET or PV patients diagnosed before acceleration phase and treated by hydroxyurea with a follow up period of at least 6 months following treatment start.
* Diagnosis criteria of PV :
* WHO criteria of PV with :
* Acquired JAK2V617F mutation \> 5%
* Absence of evident cause of secondary polycythemia
* Diagnosis criteria of ET :
* Platelet count \> 450 G/L
* Absence of PV or Chronic Myeloid Leukemia
* Bone marrow biopsy preferred but not necessary in absence of reactional causes (CRP and ferritin levels normal) and/or presence of acquired JAK2V617F, CALR exon 9 or MPL exon 10
* Availability of RNA sample of total leukocytes before start of treatment.
Exclusion Criteria:
In absence of clonality marker, presence of secondary cause of :
* Thrombocytosis :
* Inflammatory syndrom (CRP or SV increased)
* Iron deficiency (decreased ferritin level or increased soluble transferrin receptor level)
* Polycythemia :
* Increased or normal level of EPO in context of :
* Hypoxia, respiratory insufficiency
* Sleep apnea syndrome
* Hyperaffin hemoglobin
* Absence of treatment by hydroxyurea
* Treatment by anagrelide, P32, pipobroman, interferon without subsequent hydroxyurea treatment.
* Concommitant treatment by other cancer chemotherapy (in a context of solid cancer for example).
* Diagnostic during transformation to acute leukemia
* Treatment by hydroxyurea during less than 6 months
* Bad observance of the cytotoxic treatment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To correlate endoplasmic reticulum stress (defined as splicing of XBP1 above 30%) to the rate of complete response after 6 months according to the 2009 ELN criteria