Interleukin-1 inhibition to improve the response of myeloproliferative neoplasms resistant to cytoreductive treatment

Conditions

myeloproliferative neoplasms

Brief summary

Baseline and 3-month serum calprotectin levels.

Detailed description

- Improvement (yes/no) of the response statusresponse status (according to ELN criteria) between baseline-M3, baseline-M6, M3-M6, - hematological parameters (e.g., hemoglobin, hematocrit, white blood cell count, platelet count) at baseline, 3 and 6 months.., - Patient-reported symptom severity over the previous 4 weeks assessed using a 10-point Visual Analog Scale (VAS) for pruritus, fever, and night sweats at baseline, 3 and 6 months., - Treatment-related adverse events (type and number), - Daily self-reported treatment intake (Yes/No) recorded in the patient diary over the 3-month period, - EORTC QLQ-C30 score at baseline, 3 and 6 months, - Multiplex assay of inflammatory cytokines at baseline, 3 and 6 months, - Quantification of JAK2V617F, CALR exon 9, or MPL W515 at baseline, 3 and 6 months, - Measurement of circulating CD34+ cells at baseline, 3 and 6 months

Related papers

No related papers found yet.

Interventions

DRUGKineret 100 mg/0.67 ml solution for injection in pre-filled syringe.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Baseline and 3-month serum calprotectin levels.	—

Secondary

Measure	Time frame
- Improvement (yes/no) of the response statusresponse status (according to ELN criteria) between baseline-M3, baseline-M6, M3-M6, - hematological parameters (e.g., hemoglobin, hematocrit, white blood cell count, platelet count) at baseline, 3 and 6 months.., - Patient-reported symptom severity over the previous 4 weeks assessed using a 10-point Visual Analog Scale (VAS) for pruritus, fever, and night sweats at baseline, 3 and 6 months., - Treatment-related adverse events (type and number), - Daily self-reported treatment intake (Yes/No) recorded in the patient diary over the 3-month period, - EORTC QLQ-C30 score at baseline, 3 and 6 months, - Multiplex assay of inflammatory cytokines at baseline, 3 and 6 months, - Quantification of JAK2V617F, CALR exon 9, or MPL W515 at baseline, 3 and 6 months, - Measurement of circulating CD34+ cells at baseline, 3 and 6 months	—

Measure

Time frame

- Improvement (yes/no) of the response statusresponse status (according to ELN criteria) between baseline-M3, baseline-M6, M3-M6, - hematological parameters (e.g., hemoglobin, hematocrit, white blood cell count, platelet count) at baseline, 3 and 6 months.., - Patient-reported symptom severity over the previous 4 weeks assessed using a 10-point Visual Analog Scale (VAS) for pruritus, fever, and night sweats at baseline, 3 and 6 months., - Treatment-related adverse events (type and number), - Daily self-reported treatment intake (Yes/No) recorded in the patient diary over the 3-month period, - EORTC QLQ-C30 score at baseline, 3 and 6 months, - Multiplex assay of inflammatory cytokines at baseline, 3 and 6 months, - Quantification of JAK2V617F, CALR exon 9, or MPL W515 at baseline, 3 and 6 months, - Measurement of circulating CD34+ cells at baseline, 3 and 6 months

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Outcome results

None listed