Trial · NCT05870475
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The cumulative complete hematologic response (CHR) rate | From the start of study treatment (Week 0) up to the end of Week 24. | The proportion of patients who can achieve CHR ( defined as hematocrit lower than 45% without phlebotomies; platelet count \< 400×109/L, WBC count \< 10×109/L for at least 12 weeks) among all patients. |
| Secondary | Cumulative CHR rates at Week 36. | From the start of study treatment (Week 0) up to the end of Week 36. | Cumulative CHR rates at Week 36 will be compared between the two groups. |
| Secondary | Cumulative CHR rates at Week 52. | From the start of study treatment (Week 0) up to the end of Week 52. | Cumulative CHR rates at Week 52 will be compared between the two groups. |
| Secondary | Time to CHR | From the start of study treatment (Week 0) up to the end of Week 52. | The time of reaching CHR will be compared between the two groups. |
| Secondary | The CHR rates after crossover | From the start of study treatment (Week 0) up to the end of Week 52. | The CHR rates within 52 weeks after crossover |
| Secondary | The rate of reduction in JAK2V617F, CALR, or MPL gene mutation burden. | From the start of study treatment (Week 0) up to the end of Week 52. | The rate of reduction in JAK2V617F, CALR, or MPL gene mutation burden will be compared between the two groups. |
| Secondary | Impact of therapy on non-driver mutations | From the start of study treatment (Week 0) up to the end of Week 52. | To compare the proportion of subjects that display change on key non-driver biomarkers of the disease-DNMT3A, ASXL1, TET2 or other mutations. |
| Secondary | Change of splenomegaly | From the start of study treatment (Week 0) up to the end of Week 52.] | All subjects with palpable splenomegaly at baseline will undergo ultrasound examination. For subjects with palpable splenomegaly at baseline: Improvement - no palpable splenomegaly during clinical treatment visits; No progress - ultrasound examination during clinical treatment visits shows an increase in spleen size of ≤ 25%; Progress - Ultrasound examination during clinical treatment visits shows an increase in spleen size of\>25%. |
| Secondary | Change of bone marrow pathology | From the start of study treatment (Week 0) up to the end of Week 52 | Bone marrow histological remission defined as the presence of age-adjusted normocellularity and disappearance of trilinear hyperplasia, and absence of grade 1 reticulin fibrosis; no remission defined as the persistence of trilinear hyperplasia; progression defined as disease transformation into post-PV myelofibrosis, myelodysplastic syndrome or acute leukemia. |
| Secondary | The incidence of major thrombotic events | From the start of study treatment (Week 0) up to the end of Week 52. | To compare the incidence of major thrombotic events between the two groups. |
| Secondary | The incidence of major bleeding events | From the start of study treatment (Week 0) up to the end of Week 52. | To compare the incidence of major bleeding events between the two groups. |
| Secondary | The incidence of progressing to acute leukemia | From the start of study treatment (Week 0) up to the end of Week 52. | The incidence of progressing to acute leukemia will be compared between the two groups. |
| Secondary | Change in Myeloproliferative Neoplasm Symptom Assessment Form total symptom score | From the start of study treatment (Week 0) up to the end of Week 52. | To compare the proportion of subjects that display change in Myeloproliferative Neoplasm Symptom Assessment Form total symptom score (0-100 scores, higher scores mean a worse outcome) between different treatment groups. |
| Secondary | Change of quality of life using QLQ-C30 V3.0 questionnaire. | From the start of study treatment (Week 0) up to the end of Week 52. | The QLQ-C30 V3.0 questionnaire consists of 30 questions, with questions 1-28 scoring 1-4 and questions 29 and 30 scoring 1-7. Therefore, this questionnaire has a minimum score of 30 and a maximum score of 126, and the score is directly proportional to the quality of life. |
| Secondary | Change of microcirculation disturbance | From the start of study treatment (Week 0) up to the end of Week 52. | The rate of patients with improvement in microcirculation disturbance (such as pruritus, headache, dizziness, chest tightness, erythematous limb pain and limb paresthesia) will be compared between the two groups |
| Secondary | Specific pre-defined toxicity | From the start of study treatment (Week 0) up to the end of Week 52. | To compare incidence of specific pre-defined toxicity including fatigue, flu-like symptoms, dizziness, injection site necrosis, dyspnea, pain, depression, blurred Vision, insomnia, anorexia, weight Loss, weakness, pruritis, sweating, fever, decreased Libido, hot Flashes, flushing, infection, |
| Other | Changes of T lymphocytes | From the start of study treatment (Week 0) up to the end of Week 52. | Change in the proportion and gene expression profile of T lymphocytes |
| Other | Changes of B lymphocytes | From the start of study treatment (Week 0) up to the end of Week 52. | Change in the proportion and gene expression profile of B lymphocytes |
| Other | Changes of dendritic cells | From the start of study treatment (Week 0) up to the end of Week 52. | Change in the proportion and gene expression profile of dendritic cells |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT05870475/registered