Trial · NCT07468916
Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
NCT07468916, Phase 2, Not yet recruiting, Jonsson Comprehensive Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia. Trials, record NCT07468916. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07468916
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
- NCT number
- NCT07468916
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 35 participants, estimated
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Conditions
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic/Myeloproliferative Neoplasm, Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Not Otherwise Specified, Myelodysplastic/Myeloproliferative Neoplasm, Not Otherwise Specified
- Interventions
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Questionnaire Administration, Ropeginterferon Alfa-2B
- First posted
- 2026-03-13
- Last updated
- 2026-11-05
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response | Up to 24 months | Will be assessed per the 2015 international consortium proposal (ICP) myelodysplastic syndrome (MDS)/myeloproliferative neoplasm (MPN) criteria. Overall response rate is defined as the best objective 2015 ICP MDS/MPN response achieved at any time on study (complete remission, complete cytogenetic remission, partial remission, marrow response or clinical benefit). Will be summarized as proportions with corresponding 95% exact binomial confidence intervals. |
| Primary | Incidence of adverse events | Up to 24 months | The incidence of adverse events, both hematological and non-hematological will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will be summarized as proportions with corresponding 95% exact binomial confidence intervals. |
| Secondary | Cytogenetics | At baseline | Statistical analyses will primarily be descriptive. All other safety and efficacy endpoints will be summarized using appropriate descriptive statistics, including counts and proportions for categorical variables and means, medians, standard deviations, and ranges for continuous variables. |
| Secondary | Mutation profile | At baseline | Statistical analyses will primarily be descriptive. All other safety and efficacy endpoints will be summarized using appropriate descriptive statistics, including counts and proportions for categorical variables and means, medians, standard deviations, and ranges for continuous variables. |
| Secondary | Chronic myelomonocytic leukemia-specific prognostic scoring system - molecular risk | At baseline | Statistical analyses will primarily be descriptive. All other safety and efficacy endpoints will be summarized using appropriate descriptive statistics, including counts and proportions for categorical variables and means, medians, standard deviations, and ranges for continuous variables. |
| Secondary | Clinical benefit | Every 3 cycles (cycle length = 28 days) | Will be based on 2015 ICP MDS/MPN criteria. Statistical analyses will primarily be descriptive. All other safety and efficacy endpoints will be summarized using appropriate descriptive statistics, including counts and proportions for categorical variables and means, medians, standard deviations, and ranges for continuous variables. |
| Secondary | Progression-free survival | From initiation of treatment to disease progression or death, assessed up to 24 months | Progression will be evaluated per 2015 ICP MDS/MPN criteria. Will be analyzed using the Kaplan-Meier method, with median times and associated 95% confidence intervals estimated using the Brookmeyer-Crowley method. |
| Secondary | Overall survival | From initiation of treatment to death, assessed up to 24 months | Will be analyzed using the Kaplan-Meier method, with median times and associated 95% confidence intervals estimated using the Brookmeyer-Crowley method. |
| Secondary | Change in mutant allele frequencies | From baseline to every 3rd cycle (cycle length = 28 days) | Will evaluate the change from baseline mutant allele frequencies, with special interests in ASXL1, SRSF2, NRAS, KRAS, SETBP1, RUNX1, CBL, EZH2, SF3B1 mutations; as also in non-driver mutations. Statistical analyses will primarily be descriptive. All other safety and efficacy endpoints will be summarized using appropriate descriptive statistics, including counts and proportions for categorical variables and means, medians, standard deviations, and ranges for continuous variables. |
| Secondary | Percent change in splenomegaly | Every cycle (for clinical exam) and on day 1 of cycles 4 and 7 and at end of treatment (for computed tomography) (cycle length = 28 days) | Will be evaluated by clinical exam and on computed tomography. Statistical analyses will primarily be descriptive. All other safety and efficacy endpoints will be summarized using appropriate descriptive statistics, including counts and proportions for categorical variables and means, medians, standard deviations, and ranges for continuous variables. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07468916
GET https://conductscience.org/api/trials/v1/NCT07468916/registered