Trial · NCT07033598
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 | Clinical benefit at Week 24, defined as achieving erythroid response in the absence of leukemic transformation. | Measured from Week 24 through the end of treatment, up to 48 weeks. | For participants with baseline hemoglobin \<10 g/dL, response is defined as either a ≥1.5 g/dL hemoglobin increase lasting ≥8 weeks without red blood cell transfusion, or, if transfusion-dependent at baseline (≥4 units in the 8 weeks pre-enrollment), achieving ≥8 weeks of red blood cell transfusion independence, excluding transfusions given for pretreatment Hb ≤8.5 g/dL. Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma. |
| Primary | Clinical benefit at Week 24, defined as achieving platelet response in the absence of leukemic transformation. | Measured from Week 24 through the end of treatment, up to 48 weeks. | For participants with baseline platelet counts \<100 × 10⁹/L, response is defined as one of the following: an increase to ≥20 × 10⁹/L and by ≥100% for ≥8 weeks without platelet transfusion (if baseline \<20 × 10⁹/L); an increase of ≥30 × 10⁹/L for ≥8 weeks without transfusion (if baseline 20-\<100 × 10⁹/L); or, if transfusion-dependent at baseline (≥4 units in the 8 weeks pre-enrollment), achieving ≥8 weeks of platelet transfusion independence. Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma. |
| Primary | Clinical benefit at Week 24, defined as achieving neutrophil response in the absence of leukemic transformation. | Measured from Week 24 through the end of treatment, up to 48 weeks. | For participants with baseline ANC ≤1 × 10⁹/L, response is defined as either an increase to \>0.5 × 10⁹/L and by ≥100% for ≥8 weeks without myeloid growth factors (if baseline ANC ≤0.5 × 10⁹/L), or an increase by ≥50% for ≥8 weeks without myeloid growth factors (if baseline ANC \>0.5 to ≤1 × 10⁹/L). Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma. |
| Primary | Clinical benefit at Week 24, defined as achieving spleen response in the absence of leukemic transformation. | Measured from Week 24 through the end of treatment, up to 48 weeks. | For participants with baseline spleen ≥5 cm below the left costal margin (midclavicular line), spleen response is defined as a ≥35% reduction in spleen volume at endpoint assessment by MRI or CT. Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma. |
| Primary | Clinical benefit at Week 24, defined as achieving symptom response in the absence of leukemic transformation. | Measured from Week 24 through the end of treatment, up to 48 weeks. | Among participants with baseline Total Symptom Score (TSS) ≥20 per the MPN-SAF TSS: achieving ≥50% TSS reduction from baseline at the time of endpoint assessment. Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma. |
| Secondary | Clinical benefit at any time, defined as achieving at least one of the primary endpoint clinical benefit response criteria at any time on study. | Measured from the start of study treatment to the end of treatment, for up to 48 weeks. | |
| Secondary | Achieving response at Week 24 and 48 according to the IWG 2015 criteria), including the following subtypes: complete response, complete cytogenetic remission, partial remission, marrow response | Measured from Week 24 through the end of treatment, up to 48 weeks. | |
| Secondary | Duration of response for primary endpoint (clinical benefit by Week 24) | Measured from Week 24 through the end of treatment, up to 48 weeks. | |
| Secondary | Event-free survival | Measured from the start of study treatment to the end of treatment, for up to 48 weeks. | Event-free survival is defined as the time without death from any cause, transformation to AML (including granulocytic sarcoma), or disease progression after ≥3 cycles (Week 12), including CMML-1 to CMML-2 with ≥5% absolute blast increase or worsening splenomegaly. |
| Secondary | Leukemia-free survival, where events include death from any cause or transformation to AML (including granulocytic sarcoma) | Measured from the start of study treatment to the end of treatment, for up to 48 weeks. | |
| Secondary | Overall survival | Measured from the date of initiating study treatment to the date of death from any cause, assessed up to 24 months. | |
| Secondary | Incidence of allogeneic hematopoietic stem cell transplant. | Measured from the date of initiating study treatment to the date of allogeneic hematopoietic stem cell transplant., assessed for up to 24 months | |
| Secondary | Adverse events and laboratory abnormalities as graded by NCI CTCAE v5.0. | From the start of the adverse event collection period through 30 days following the last dose of study treatment. | |
| Secondary | Change in arterial blood pressure measured in mmHg. | From the start of the study treatment through 30 days following the last dose of study treatment. | |
| Secondary | Change in pulse rate measured in beats per minute. | From the start of the study treatment through 30 days following the last dose of study treatment. | |
| Secondary | Change in respiratory rate measured in breaths per minute. | From the start of the study treatment through 30 days following the last dose of study treatment. | |
| Secondary | Change in corrected QT interval measured in milliseconds using 12-lead electrocardiogram. | From the start of the study treatment through 30 days following the last dose of study 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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