Trial · NCT02638467
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 | Efficacy as assessed by the percentage of patients with Complete Cytogenetic Response (CCyR) | 12 months | The percentage of patients with Complete Cytogenetic Response (CCyR) will be calculated as the complement to the percentage of failures on the total number of patients treated, where failure includes the following events: no engraftment, death within 12 months, no CCyR at 12 months. |
| Secondary | Overall Survival | 12 months | |
| Secondary | Percentage of patients with engraftment | 12 months | |
| Secondary | percentage of patients with complete chimerism (95%) | Day +28, +56 and +100 | |
| Secondary | Evaluation of Major Cytogenetic Response (MCyR) | 12 months | Major Cytogenetic Response (MCyR) is \< 36% Ph+ metaphases |
| Secondary | Evaluation of molecular responses | 12 months | Molecular response is defined * Complete: if there is undetectable BCR-ABL transcript * Major: if ratio BCR/ABL \<= 0.1% on International Scale |
| Secondary | Relapse incidence (RI) | 12 months | |
| Secondary | Incidence of non-relapse mortality (NRM) | Within day +28 and +360 | |
| Secondary | Incidence and severity of acute and chronic graft vs. host disease (GvHD) | 12 months | |
| Secondary | Quality of Life (QoL) | 12 months | Evaluation of QoL with EQ-5D-5L (Italian - Version 2) and FACT-Leu (Italian -Version 4) |
| Secondary | Overall Survival (OS) | 36 months | 2 years after transplantation of the last patient included (this is intended to allow evaluations of all expected major molecular responses) |
| Secondary | Progression Free Survival (PFS) | 36 months | 2 years after transplantation of the last patient included (this is intended to allow evaluations of all expected major molecular responses) |
| Secondary | Relapse Incidence (RI) | 36 months | 2 years after transplantation of the last patient included (this is intended to allow evaluations of all expected major molecular responses) |
| Secondary | Chronic Graft-versus-host Disease (cGvHD) | 36 months | 2 years after transplantation of the last patient included (this is intended to allow evaluations of all expected major molecular responses) |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02638467/registered