Trial · NCT04147533
Registered outcomes142
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 142
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | proportion of patients in major molecular response, and MRFS at month 6 | 6 months after entry | Proportion of patients in major molecular response (MMR) ie BCR-ABL1 (oncogenic BCR-ABL gene fusion) transcript levels \<= 0.1%) and Molecular Recurrence-Free Survival (MRFS, ie time from study entry to MMR loss, ie BCR-ABL1 transcript levels \> 0.1% in 2 consecutive samples, or death from any cause) at month 6 after study entry |
| Primary | proportion of patients in major molecular response (MMR) and MRFS at month 12 | 12 months after study entry | Proportion of patients in major molecular response (MMR) and MRFS at month 12 after study entry |
| Primary | proportion of patients in MMR without treatment (TFR) and treatment-free survival at month 18 after study entry, ie. 6 months after treatment withdrawal | 18 months after study entry | The proportion of patients in MMR without treatment (TFR) and treatment-free survival (TFS, ie the time from withdrawal of TKI (tyrosin kinase inhibitors) to loss of MMR, reinitiation of TKI therapy from any cause, progression, or death from any cause) at month 18 after study entry, ie, 6 months after treatment discontinuation |
| Primary | proportion of patients in MMR without treatment (TFR) and treatment-free survival at month 24 after study entry, ie. 12 months after treatment withdrawal | 24 months after study entry | The proportion of patients in MMR without treatment (TFR) and treatment-free survival (TFS, ie the time from withdrawal of TKI to loss of MMR, reinitiation of TKI therapy from any cause, progression, or death from any cause) at month 24 after study entry, ie 12 months after treatment discontinuation |
| Primary | proportion of patients in MMR without treatment (TFR) and treatment-free survival at month 36 after study entry, ie. 24 months after treatment withdrawal | 36 months after study entry | The proportion of patients in MMR without treatment (TFR) and treatment-free survival (TFS, ie the time from withdrawal of TKI to loss of MMR, reinitiation of TKI therapy from any cause, progression, or death from any cause) at month 36 after study entry, ie 24 months after treatment discontinuation |
| Secondary | Proportion of patients who lose MMR during de-escalation and in whom MMR and MR4.0 will recover after TKI re-introduction | every two months in the first 12 months, at early termination (due to pregnancy, investigator's,national competent authority's or sponsor's decision, poor adherence) | Proportion of patients who lose MMR during de-escalation and in whom MMR and MR4.0 (deep molecular response, level of BCR-ABL transcripts \<0.01% related to the international scale) will recover after TKI re-introduction |
| Secondary | Proportion of patients who lose MMR after discontinuation of TKI and in whom MMR and MR4.0 will recover after TKI re-introduction | every month between month 13 and 18, every 1.5 month between month 18 and 24, every 3 months between month 24 and 36, at time of early termination | Proportion of patients who lose MMR after discontinuation of TKI and in whom MMR and MR4.0 will recover after TKI re-introduction |
| Secondary | Time to re-establish MMR and MR4.0 after TKI restart | since TKI restart until MMR and MR4.0 recovered (only in case that restart is necessary) | Time to re-establish MMR and MR4.0 after TKI restart - evaluation every 3 months after TKI restart |
| Secondary | Assessment of TKI's adverse effects dynamics during two-step reduction of their dose before withdrawal | every two months in the first 12 months, at early termination (due to pregnancy, investigator's,national competent authority's or sponsor's decision, poor adherence) | Assessment of TKI's adverse effects dynamics during two-step reduction of their dose before withdrawal (using Common Terminology Criteria for Adverse Events; CTCAE classification with 5 grades) |
| Secondary | Assessment of TKI withdrawal syndrome - proportion of patients with development of withdrawal syndrome | months 2,4,6,8,10,12,13,14,15,16,17,18,19.5,21,22.5,24,27,30,33,36 | Assessment of TKI withdrawal syndrome - proportion of patients with development of withdrawal syndrome) (using Common Terminology Criteria for Adverse Events; CTCAE classification with 5 grades) |
| Secondary | Assessment of TKI withdrawal syndrome - severity of symptoms | months 2,4,6,8,10,12,13,14,15,16,17,18,19.5,21,22.5,24,27,30,33,36 | Assessment of TKI withdrawal syndrome - severity of symptoms (using Common Terminology Criteria for Adverse Events; CTCAE classification with 5 grades) |
| Secondary | Assessment of TKI withdrawal syndrome - time to first complaint | months 2,4,6,8,10,12,13,14,15,16,17,18,19.5,21,22.5,24,27,30,33,36 | Assessment of TKI withdrawal syndrome - time to first complaint |
| Secondary | Assessment of TKI withdrawal syndrome - duration of complaints | months 2,4,6,8,10,12,13,14,15,16,17,18,19.5,21,22.5,24,27,30,33,36 | Assessment of TKI withdrawal syndrome - duration of complaints |
| Secondary | Assessment of TKI withdrawal syndrome - therapeutic intervention | months 2,4,6,8,10,12,13,14,15,16,17,18,19.5,21,22.5,24,27,30,33,36 | Assessment of TKI withdrawal syndrome - therapeutic intervention (pharmacological history, dose changes) |
| Secondary | Assessment of the correlation between adverse effects on previous TKI treatment and possible withdrawal syndrome | months 2,4,6,8,10,12,13,14,15,16,17,18,19.5,21,22.5,24,27,30,33,36 | Assessment of the correlation between adverse effects on previous TKI treatment and possible withdrawal syndrome (using Common Terminology Criteria for Adverse Events; CTCAE classification with 5 grades) |
| Secondary | BCR-ABL1 kinetics during TKI therapy | months 2,4,6,8,10,12,13,14,15,16,17,18,19.5,21,22.5,24,27,30,33,36 | number of BCR-ABL1 transcripts during TKI therapy |
| Secondary | Correlation of BCR-ABL1 kinetics (number of BCR-ABL1 transcripts in time) during TKI therapy with potential molecular relapse after TKI discontinuation | months 2,4,6,8,10,12,13,14,15,16,17,18,19.5,21,22.5,24,27,30,33,36 | Correlation of BCR-ABL1 kinetics during TKI therapy with potential molecular relapse after TKI discontinuation |
| Secondary | Correlation of the effect of TKI dose reduction and subsequent discontinuation with lipid metabolism and glycemia (using Common Terminology Criteria for Adverse Events; CTCAE classification with 5 grades) | months 2,4,6,8,10,12,15,18,21,24,30,36 | Correlation of the effect of TKI dose reduction and subsequent discontinuation with lipid metabolism and glycemia (using Common Terminology Criteria for Adverse Events; CTCAE classification with 5 grades) |
| Other | failure-free survival | months 2,4,6,8,10,12,13,14,15,16,17,18,19.5,21,22.5,24,27,30,33,36 | failure-free survival |
| Other | progression-free survival | months 2,4,6,8,10,12,13,14,15,16,17,18,19.5,21,22.5,24,27,30,33,36 | progression-free survival |
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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