Trial · NCT07498205
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To estimate and compare the proportion of participants achieving a dual response [SVR35] and transfusion independence response from red blood cell transfusions. | 24 weeks after randomization | To estimate and compare the proportion of patients achieving a dual response both spleen response \[SVR35\] and transfusion independence response \[TI-R\] from red blood cell transfusions at week 24 post-Step 1 randomization in JAK-inhibitor naïve participants with myelofibrosis treated with momelotinib versus ruxolitinib. |
| Secondary | TI-R Rate | 24 weeks after Step 1 Randomization | To estimate and compare the TI-R rate at week 24, post-Step 1 randomization in each treatment arm. |
| Secondary | SVR35 at week 24 post-randomization | 24 weeks after Step 1 Randomization | To estimate and compare the rates of SVR35 at week 24 post-randomization in each treatment arm. |
| Secondary | OS | 96 weeks after Step 1 Randomization | To estimate overall survival (OS) in each treatment arm. |
| Secondary | PFS | 96 weeks after Step 1 Randomization | To estimate progression-free survival (PFS) in each treatment arm. |
| Secondary | SVR35 at week 24 post-randomization | 24 weeks after Step 1 Randomization | To estimate and compare SVR35 at week 24 post-randomization in each treatment arm with a sensitivity analysis based on a modeled version of the continuous spleen response rate. |
| Secondary | Allogeneic Transplantation | 96 weeks after Step 1 Randomization | To tabulate the proportion of participants in each arm who undergo allogeneic transplantation at week 24 and week 48 post-Step 1 randomization. |
| Secondary | Cross-over | 72 weeks after Step 1 Randomization | To tabulate the number of participants on each arm who cross over. |
| Secondary | Time to next non-protocol treatment | 96 weeks after Step 1 Randomization | To estimate and compare the time to next non-protocol treatment (excludes crossover) in each treatment arm. |
| Secondary | SVR35 | 48 weeks after Step 1 Randomization | To estimate and compare the rates of SVR35 at week 48 post-Step 1 randomization by treatment arm and stratified by cross-over-status. |
| Secondary | TI-R | 48 weeks after Step 1 Randomization | To estimate and compare the rates of TI-R at week 48 post-Step 1 randomization by treatment arm and stratified by cross-over-status. |
| Secondary | Dual Response | 48 weeks after Step 1 Randomization | To estimate and compare the rates of dual response (SVR35 + TI-R) at week 48 post-Step 1 randomization by treatment arm and stratified by cross-over-status. |
| Secondary | To estimate the frequency of and severity of toxicities in each treatment arm | 48 weeks after Step 1 Randomization | To estimate and compare the frequency of major anemia response per 2024 IWG-ELN criteria in each treatment arm by week 24 and by week 48 (week 48 stratified by cross-over-status). |
| Secondary | Major anemia response | 48 weeks after Step 1 Randomization | To estimate and compare the frequency of major anemia response per 2024 IWG-ELN criteria in each treatment arm by week 24 and by week 48 (week 48 stratified by cross-over-status). |
| Secondary | Time to initiation of anemia-directed therapy | 48 weeks after Step 1 Randomization | To estimate and compare the time to initiation of anemia-directed therapy in each treatment arm among participants not on anemia-directed therapy at registration by week 24 and by week 48 (week 48 stratified by cross-over-status). |
| Other | Symptom Burden | 96 weeks after Step 1 Randomization | To compare symptom burden by arm at week 24 using the Myelofibrosis Symptom Assessment Form version 4.0 (MF-SAF v4.0) total score and the Functional Assessment of Cancer Therapy - Anemia (FACT-An) total score |
| Other | MF-SAF Scores | 96 weeks after Step 1 Randomization | To compare by arm individual item scores from the MF-SAF v4.0. |
| Other | FACT-An Scores | 96 weeks after Step 1 Randomization | To compare by arm individual item subscale scores from the FACT-An. |
| Other | Longitudinal Trajectories | 96 weeks after Step 1 Randomization | To examine by arm differences in longitudinal trajectories over time in the MF-SAF v4.0 total score, the FACT-An total score, and MF-SAF v4.0 item scores and FACT-An subscale scores. |
| Other | Specimen Banking | 96 weeks after Step 1 Randomization | To bank specimens for future correlative studies. |
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.
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