Trial · NCT07071155
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants who achieve a complete response | 24 weeks | Efficacy determination - complete response: number of participants who achieve a complete response as defined by international consortium response criteria for MDS/MPN in adults |
| Primary | Number of participants who achieve a partial response | 24 weeks | Efficacy determination - partial response: number of participants who achieve a partial response as defined by international consortium response criteria for MDS/MPN in adults |
| Primary | Number of participants who achieve a clinical benefit | 24 weeks | Efficacy determination - clinical benefit: number of participants who achieve a clinical benefit per MDS/MPN IWG criteria4 |
| Secondary | Number of participants who experience a grade 3 or higher adverse events or severe event | 2 years | Safety and tolerability evaluation: number of participants who experience a grade 3 or higher adverse event events or severe adverse events as defined by CTCAE v.5.0 |
| Secondary | Number of Participants Who Achieve Erythroid Response | 12 weeks | Number of patients who achieve erythroid response at week 12 per international consortium criteria |
| Secondary | Number of Participants Who Achieve Erythroid Response | 24 weeks | Number of participants who achieve erythroid response at week 24 per international consortium criteria |
| Secondary | Proportion of Participants Who Achieve Spleen Size Reduction | 12 weeks | Determine the proportion of participants who achieve a spleen volume reduction of ≥ 35% from baseline at week 12 |
| Secondary | Proportion of participants Who Achieve Spleen Size Reduction | 24 weeks | Determine the proportion of participants who achieve a spleen volume reduction of ≥ 35% from baseline at week 24 |
| Secondary | Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) | 12 weeks | Evaluate efficacy of momelotinib plus hypomethylating agents azacitidine or decitabine (MMB-HMA) on MPN-SAF TSS questionnaire. Score range 0-100, higher score worse symptoms. |
| Secondary | Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) | 24 weeks | Evaluate efficacy of momelotinib plus hypomethylating agents azacitidine or decitabine (MMB-HMA) on MPN-SAF TSS questionnaire. Score range 0-100, higher score worse symptoms. |
| Secondary | Patient Global Impression of Change (PGIC) questionnaire | 12 weeks | Evaluate efficacy of momelotinib plus hypomethylating agents azacitidine or decitabine (MMB-HMA) on Patient Global Impression of Change (PGIC) questionnaire. A 7-point scale (1-7) rating of overall improvement. Patients rate their change as 1="very much improved," 2="much improved," 3="minimally improved," 4="no change," 5="minimally worse," 6="much worse," or 7="very much worse." Lower values represent a better outcome. |
| Secondary | Patient Global Impression of Change (PGIC) | 24 weeks | Evaluate efficacy of momelotinib plus hypomethylating agents azacitidine or decitabine (MMB-HMA) on Patient Global Impression of Change (PGIC) questionnaire. A 7-point scale (1-7) rating of overall improvement. Patients rate their change as 1="very much improved," 2="much improved," 3="minimally improved," 4="no change," 5="minimally worse," 6="much worse," or 7="very much worse." Lower values represent a better outcome. |
| Secondary | Trough concentrations of MMB as single agent and in combination with HMA | 12 weeks | Evaluate trough concentrations at week 12 in Arm A and B |
| Secondary | Trough concentrations of MMB as single agent and in combination with HMA | 24 weeks | Evaluate trough concentrations at week 24 in Arm A and B |
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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GET https://conductscience.org/api/trials/v1/NCT07071155/registered