Trial · NCT07512700
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Complete Remission Rate | At the end of Cycle 2 (each cycle is 28 days) | Proportion of participants achieving composite complete remission (CRc = CR + CRi) after one cycle of treatment. CR is defined as no clinical leukemic symptoms, hemoglobin ≥100 g/L (male) or ≥90 g/L (female/children), ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, no blasts in peripheral blood, and bone marrow blasts ≤5% with normal erythroid and megakaryocytic lineages. CRi meets all CR criteria except residual neutropenia (ANC \<1.0×10⁹/L) or thrombocytopenia (platelets \<100×10⁹/L). |
| Secondary | Complete Remission Rate after Cycle 1 | At the end of Cycle 1 (each cycle is 28 days) | Proportion of participants achieving complete remission (CR) after one cycle of treatment. CR is defined as absence of clinical symptoms and signs of leukemic infiltration; hemoglobin ≥100 g/L (male) or ≥90 g/L (female and children), absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, no blasts in peripheral blood differential, and bone marrow blasts (type I + II) ≤5% with normal erythroid and megakaryocytic lineages. |
| Secondary | Complete Remission with Incomplete Count Recovery Rate after Cycle 1 | At the end of Cycle 1 (each cycle is 28 days) | Proportion of participants achieving complete remission with incomplete count recovery (CRi) after one cycle of treatment. CRi is defined as meeting all CR criteria except for residual neutropenia (absolute neutrophil count \<1.0×10⁹/L) or thrombocytopenia (platelet count \<100×10⁹/L). |
| Secondary | Overall Response Rate after Cycle 1 | At the end of Cycle 1 (each cycle is 28 days) | Proportion of participants achieving overall response after one cycle of treatment. Overall response is defined as the sum of complete remission (CR), complete remission with incomplete count recovery (CRi), and partial remission (PR). |
| Secondary | Partial Remission Rate after Cycle 1 | At the end of Cycle 1 (each cycle is 28 days) | Proportion of participants achieving partial remission (PR) after one cycle of treatment. PR is defined as a reduction of bone marrow blasts by more than 50%, with a final blast percentage between 5% and 25%, and recovery of peripheral blood counts to normal. |
| Secondary | Minimal Residual Disease Negative Rate after Cycle 1 | At the end of Cycle 1 (each cycle is 28 days) | Proportion of participants achieving minimal residual disease (MRD) negativity after one cycle of treatment. MRD negativity is defined as the absence of measurable residual disease as assessed by immunologic or molecular methods. |
| Secondary | Composite Complete Remission Rate after Cycle 1 | At the end of Cycle 1 (each cycle is 28 days) | Proportion of participants achieving composite complete remission (CRc = CR + CRi) after two cycles of treatment. |
| Secondary | Complete Remission Rate after Cycle 2 | At the end of Cycle 2 (each cycle is 28 days) | Proportion of participants achieving complete remission (CR) after two cycles of treatment. CR is defined as absence of clinical symptoms and signs of leukemic infiltration; hemoglobin ≥100 g/L (male) or ≥90 g/L (female and children), absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, no blasts in peripheral blood differential, and bone marrow blasts (type I + II) ≤5% with normal erythroid and megakaryocytic lineages. |
| Secondary | Complete Remission with Incomplete Count Recovery Rate after Cycle 2 | At the end of Cycle 2 (each cycle is 28 days) | Proportion of participants achieving complete remission with incomplete count recovery (CRi) after two cycles of treatment. CRi is defined as meeting all CR criteria except for residual neutropenia (absolute neutrophil count \<1.0×10⁹/L) or thrombocytopenia (platelet count \<100×10⁹/L). |
| Secondary | Partial Remission Rate after Cycle 2 | At the end of Cycle 2 (each cycle is 28 days) | Proportion of participants achieving partial remission (PR) after two cycles of treatment. PR is defined as a reduction of bone marrow blasts by more than 50%, with a final blast percentage between 5% and 25%, and recovery of peripheral blood counts to normal. |
| Secondary | Minimal Residual Disease Negative Rate after Cycle 2 | At the end of Cycle 2 (each cycle is 28 days) | Proportion of participants achieving minimal residual disease (MRD) negativity after two cycles of treatment. MRD negativity is defined as the absence of measurable residual disease as assessed by immunologic or molecular methods. |
| Secondary | Progression-Free Survival | Up to 12 months after enrollment | The time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first. Disease progression is defined according to standard criteria for acute monocytic leukemia. |
| Secondary | Overall Survival | Up to 12 months after enrollment | The time from enrollment to death from any cause. For surviving participants, data will be censored at the date of last follow-up. |
| Secondary | Relapse Rate | Up to 12 months after enrollment | The proportion of participants who achieve remission (CR or CRi) and subsequently experience disease relapse during the follow-up period. Relapse is defined according to standard criteria for acute monocytic leukemia. |
| Secondary | Duration of Remission | Up to 12 months after enrollment | The time from the first documented remission (CR or CRi) to disease relapse or death from any cause, whichever occurs first. |
| Secondary | Adverse reactions in hematology | At the end of Cycle 2 (each cycle is 28 days) | Record of adverse events in hematological system during and after treatment |
| Secondary | Nonhematological adverse reactions | At the end of Cycle 2 (each cycle is 28 days) | Record of adverse events in other organs or systmes during and after treatment |
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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