Trial · NCT06923488
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of incidences of regimen limiting toxicities (RLTs) | Date of first treatment up to 13 months | Percentages of incidences of RLTs defined as: * A need to reduce the dose of one or both of the treatments * Discontinue the treatment due to dose limiting toxicities, AE/SAE * Be withheld at the discretion of the treating physician and on the basis of the expected adverse event |
| Secondary | Percentage of Complete Remission (CR) Rate (3rd cycle) | Within 30 days following the end of the 3rd cycle (cycle = 28 days) | Percentage of patients achieving complete remission (CR) rate defined as bone marrow (BM): \<5% myeloblasts (dysplasia may persist), and peripheral blood (PB): hemoglobin (Hb) ≥10 g/dL, platelets ≥100 × 109/L; neutrophils ≥1.0 × 109/L; blasts 0%. Full cytogenetic clearance of baseline abnormalities (complete cytogenetic response) |
| Secondary | Percentage of Complete Remission (CR) Rate (6th cycle) | Within 30 days following the end of the 6th cycle (cycle = 28 days) | Percentage of patients achieving complete remission (CR) rate defined as bone marrow (BM): \<5% myeloblasts (dysplasia may persist), and peripheral blood (PB): hemoglobin (Hb) ≥10 g/dL, platelets ≥100 × 109/L; neutrophils ≥1.0 × 109/L; blasts 0%. Full cytogenetic clearance of baseline abnormalities (complete cytogenetic response) |
| Secondary | Percentage of Complete Remission (CR) Rate (12th cycle) | Within 30 days of the end of the 12th cycle (cycle = 28 days) | Percentage of patients achieving complete remission (CR) rate defined as bone marrow (BM): \<5% myeloblasts (dysplasia may persist), and peripheral blood (PB): hemoglobin (Hb) ≥10 g/dL, platelets ≥100 × 109/L; neutrophils ≥1.0 × 109/L; blasts 0%. Full cytogenetic clearance of baseline abnormalities (complete cytogenetic response) |
| Secondary | CR + complete remission with partial hematologic recovery (CRh) (3rd cycle) | Within 30 days following the end of the 3rd cycle (cycle = 28 days) | Percentage of participants that achieve CR + complete remission with partial hematologic recovery (CRh) - defined as BM: \<5% myeloblasts (dysplasia may persist) and PB: Not meeting criteria for CR or CRL, no Hb threshold required, platelets ≥50 × 109/L; neutrophils ≥0.5 × 109/L; blasts 0% |
| Secondary | CR + complete remission with partial hematologic recovery (CRh) (6th cycle) | Within 30 days following the end of the 6th cycle (cycle = 28 days) | Percentage of participants that achieve CR + complete remission with partial hematologic recovery (CRh) - defined as BM: \<5% myeloblasts (dysplasia may persist) and PB: Not meeting criteria for CR or CRL, no Hb threshold required, platelets ≥50 × 109/L; neutrophils ≥0.5 × 109/L; blasts 0% |
| Secondary | CR + complete remission with partial hematologic recovery (CRh) (12th cycle) | Within 30 days following the end of the 12th cycle (cycle = 28 days) | Percentage of participants that achieve CR + complete remission with partial hematologic recovery (CRh) - defined as BM: \<5% myeloblasts (dysplasia may persist) and PB: Not meeting criteria for CR or CRL, no Hb threshold required, platelets ≥50 × 109/L; neutrophils ≥0.5 × 109/L; blasts 0% |
| Secondary | CR + CRh + complete remission with limited count recovery (CRL) including CR bilineage (CRbi) and CR unilineage (CRuni) (3rd cycle) | Within 30 days following the end of the 3rd cycle (cycle = 28 days) | Percentage of participants that achieve CR + CRh + complete remission with limited count recovery (CRL) including CR bilineage (CRbi) and CR unilineage (CRuni) - defined as BM: \<5% myeloblasts (dysplasia may persist), and PB: blasts 0%; CRuni: PB, not meeting CR but only 1 of the following: Hb ≥10 g/dL; platelets ≥100 × 109/L; neutrophils ≥1.0 × 109/L; CRbi: PB, not meeting CR but only 2 of the following: Hb ≥10 g/dL; platelets ≥100 × 109/L; neutrophils ≥1.0 × 109/L |
| Secondary | CR + CRh + complete remission with limited count recovery (CRL) including CR bilineage (CRbi) and CR unilineage (CRuni) (6th cycle) | Within 30 days following the end of the 6th cycle (cycle = 28 days) | Percentage of participants that achieve CR + CRh + complete remission with limited count recovery (CRL) including CR bilineage (CRbi) and CR unilineage (CRuni) - defined as BM: \<5% myeloblasts (dysplasia may persist), and PB: blasts 0%; CRuni: PB, not meeting CR but only 1 of the following: Hb ≥10 g/dL; platelets ≥100 × 109/L; neutrophils ≥1.0 × 109/L; CRbi: PB, not meeting CR but only 2 of the following: Hb ≥10 g/dL; platelets ≥100 × 109/L; neutrophils ≥1.0 × 109/L |
| Secondary | CR + CRh + complete remission with limited count recovery (CRL) including CR bilineage (CRbi) and CR unilineage (CRuni) (12th cycle) | Within 30 days following the end of the 12th cycle (cycle = 28 days) | Percentage of participants that achieve CR + CRh + complete remission with limited count recovery (CRL) including CR bilineage (CRbi) and CR unilineage (CRuni) - defined as BM: \<5% myeloblasts (dysplasia may persist), and PB: blasts 0%; CRuni: PB, not meeting CR but only 1 of the following: Hb ≥10 g/dL; platelets ≥100 × 109/L; neutrophils ≥1.0 × 109/L; CRbi: PB, not meeting CR but only 2 of the following: Hb ≥10 g/dL; platelets ≥100 × 109/L; neutrophils ≥1.0 × 109/L |
| Secondary | Allogeneic hematopoietic stem cell transplant (alloHSCT) | Enrollment up to 3 years | The percentage of participants that proceed to allogeneic hematopoietic stem cell transplant (alloHSCT). |
| Secondary | Overall Survival (OS) | From first treatment up to 3 years | Overall Survival (OS) defined for all patients of the trial; measured from the first day of receiving study drugs on the clinical trial to the date of death by any cause |
| Secondary | Event-free survival (EFS) | From first treatment up to 3 years | Event-free survival (EFS) defined for all patients of the trial; measured from the first day of receiving study drugs to the date of treatment failure, or relapse from CR or CRh or CRL, or death by any cause. Treatment is defined as failure to achieve CR or CRh or CRL after at least three cycles of treatment; the date of treatment failure is defined as date of marrow evaluation after the last course of treatment. |
| Secondary | Relapse-free survival (RFS) defined only for patients achieving CR or CRh or CRL; | From the date of achievement of a CR/CRh/CRL up to 3 years | Relapse-free survival (RFS) defined only for patients achieving CR or CRh or CRL; measured from the date of achievement of a CR/CRh/CRL until the date of relapse or death from any cause; RFS and disease-free survival (DFS) have been used with the same definition. |
| Secondary | Progression to acute myeloid leukemia (AML) | Enrollment up to 3 years | Percentage of participant progression to acute myeloid leukemia (AML) |
| Secondary | Percentage of Red Blood Cell transfusion independence | Date of first treatment up to 3 years | The percentage of participants that achieve the conversion from red blood cell transfusion dependence to transfusion independence. Transfusion Independence is defined as a period of time, usually 8 weeks, with no transfusion between first dose of study drug and the last dose of study drug + 30 days. |
| Other | Percentage Clonal Evolution | Enrollment up to 3 years | Percentage of participants with clonal evolution. Defined as mutations in founding clone, expansion of subclone(s), and convergent clonal evolution of signaling gene mutations; assessed by chromosomal analysis, fluorescence in situ hybridization (FISH) and mutational analysis by next generation sequencing in bone marrow evaluation. |
| Other | Percentage of platelet transfusion independence | Date of first treatment up to 3 years | The percentage of participants that achieve the conversion from platelet transfusion dependence to transfusion independence (persons who transition from needing regular platelet transfusions to no longer requiring them). |
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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