Trial · NCT03831776
Long-acting Low Dose Ropeginterferon for Chronic Myeloid Leukemia Treated With Bosutinib From Diagnosis
NCT03831776, Phase 2, Completed, St. Olavs Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-acting Low Dose Ropeginterferon for Chronic Myeloid Leukemia Treated With Bosutinib From Diagnosis. Trials, record NCT03831776. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03831776
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-acting Low Dose Ropeginterferon for Chronic Myeloid Leukemia Treated With Bosutinib From Diagnosis
- NCT number
- NCT03831776
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 212 participants, actual
- Lead sponsor
- St. Olavs Hospital
- Conditions
- Chronic Myeloid Leukemia
- Interventions
- Bosutinib, Ropeginterferon
- First posted
- 2019-02-06
- Last updated
- 2025-06-08
- Other registries' IDs
- eudract:2018-001044-54
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of molecular response 4 (MR4) | 12 months | Molecular response 4 (MR4) is defined by either a positive BCR-ABL/ABL ratio ≤ 0.01% on the international scale (IS) or by undetectable BCR-ABL with the analysis of at least 10000 copies of ABL or 24000 copies of GUS (according to the ELN recommendations by N. Cross et al., Leukemia 2015) |
| Secondary | Rate of molecular response MR2, MR3, MR4, MR4.5 from 1 month up to 24 months and every 6 months thereafter | 2 years | |
| Secondary | Cumulative incidence of molecular response MR3, MR4, MR4.5 | 2 years | |
| Secondary | Rate of complete cytogenetic response (CCyR) up to 12 months | 12 months | |
| Secondary | Rate of undetectable molecular response for patients who achieved molecular response MR4 and MR4.5 | 2 years | |
| Secondary | Time to and duration of CCyR, MR3, MR4, MR4.5 | 2 years | |
| Secondary | proportion of patients eligible for randomization after 3 months of Bosutinib | 3 months | |
| Secondary | rate and characteristics of severe adverse events (SAE) | 2 years | type and grade according to the NCI CTCAE v4.03 |
| Secondary | Dose intensity of RoPegIFN and Bosutinib | 2 years | |
| Secondary | Cumulative incidence of discontinuation of the therapies, incl. reasons for discontinuation | 2 years |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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/NCT03831776
GET https://conductscience.org/api/trials/v1/NCT03831776/registered