Trial · NCT03831776
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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 | |
| Secondary | Quality of life assessment by QLQC30 questionnaire up to 6 years at key time point (Day 1, month 3, month 6, month 12, month 24, month 48, month 54, month 72) | 6 years | |
| Secondary | Quality of life assessment by CML24 questionnaire up to 6 years at key time point (Day 1, month 3, month 6, month 12, month 24, month 48, month 54, month 72) | 6 years | |
| Secondary | The proportion of patients achieving a durable deep molecular response and being eligible for treatment discontinuation at month 48 | 4 years | Sustained deep molecular response (MR) criteria will be defined according updated data and ELN guidelines before the first patient will achieve month 48 (at least a MR4 over a 12 months period and confirmed on the last centralized measurement at month 48 |
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.
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GET https://conductscience.org/api/trials/v1/NCT03831776/registered