Trial · NCT05395507
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete hematological remission (CHR) rates | From the start of study treatment (Week 0) up to the end of Week 52 | The CHR rates defined as European Leukemia Net will be compared between the two groups. |
| Secondary | CHR rates at week 24 and 36 | From the start of study treatment (Week 0) up to the end of Week 24 and Week 36, respectively | The CHR rates at week 24 and 36 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 proportion of patients crossed to the contralateral group | From the start of study treatment (Week 0) up to the end of Week 52. | The proportion of patients crossed to the contralateral group 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 | Impact of therapy on 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 biomarkers of the disease- JAK2V617F, CALR, MPL mutations. |
| 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. | To compare the proportion of subject with improvement and no progress rate of splenomegaly between the two groups. |
| Secondary | Change of bone marrow pathology | From the start of study treatment (Week 0) up to the end of Week 52. | To compare the rate of patients with improvement and no progress rate of bone marrow pathology between the two groups |
| 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 bone marrow fibrosis | From the start of study treatment (Week 0) up to the end of Week 52. | The incidence of progressing to bone marrow fibrosis will be compared 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 | From the start of study treatment (Week 0) up to the end of Week 52. | Compare the rate of patients with improvement in quality of life between the two groups (assessed by EORTC quality of life scale QLQ-C30 V3.0 questionnaire). |
| 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. |
| Other | Changes of immune cell subgroups | From the start of study treatment (Week 0) up to the end of Week 52. | The proportion of T lymphocyte, B lymphocyte and dendritic cell subsets and the changes of gene expression profile of these cells will be analyzed before and after treatment. |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05395507/registered