Clinical trial · Observational
Endoplasmic Reticulum Stress and Resistance to Treatments in Ph-negative Myeloproliferative Neoplasms
NCT02823184CI-TRIAL-00045618PhiNESScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Essential Thrombocythemia | Essential Thrombocythemia | ONTOLOGY_EXACT | 0.98 |
| Polycythemia Vera | Polycythemia Vera | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RNA sample of total leukocytes before start of treatment | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients
- description
- 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, with a RNA sample of total leukocytes before start of treatment available
- interventionNames
- Biological: RNA sample of total leukocytes before start of treatment
Primary outcomes (1)
- measure
- 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
- timeFrame
- After 6 months of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 treatmentReferences
Publications (0)
Data not yet available
No reference posted for this study.