Trial · NCT03416179
Registered outcomes44
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 44
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intensive Study: Overall Survival (OS) | Baseline up to 25 months | OS is defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were to be censored at the date of last contact. |
| Primary | Non-intensive Study: Overall Survival (OS) | Baseline up to 25 months | OS is defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were to be censored at the date of last contact. |
| Secondary | Intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Questionnaire | Post-baseline up to Week 8 | MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). "Fatigue" was measured at the participants' worst level in last 24 hours by asking participants to respond to each item on an 0-10 numeric rating scale (NRS), where 0 = "not present" and 10 = "as bad as you can imagine". Percentage of participants who had improvement in "fatigue" symptoms reported in this outcome measure. |
| Secondary | Non-intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MDASI-AML/MDS Questionnaire at Week 12 | Post-baseline up to Week 12 | MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). "Fatigue" was measured at the participants' worst level in last 24 hours by asking participants to respond to each item on an 0-10 NRS, where 0 = "not present" and 10 = "as bad as you can imagine". Percentage of participants who had improvement in "fatigue" symptoms reported in this outcome measure. |
| Secondary | Intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 2 years | Complete remission (CR) was defined based on 2017 European LeukemiaNet (ELN) recommendations. CR: Bone marrow blasts \<5 percentage (%); absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) greater than equal to (\>=) 1.0\*10\^9/Liter (L); platelet count \>=100\*10\^9/L. CRMRD-neg: CR with negativity for a genetic marker by reverse transcription quantitative polymerase chain reaction (RT-qPCR), or CR with negativity by Multiparameter Flow Cytometry (MFC). |
| Secondary | Non-intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 3 years | CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. CRMRDneg: CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC. |
| Secondary | Intensive Study: Percentage of Participants With Complete Remission Including Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 2 years | CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. CRMRDneg: CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC. |
| Secondary | Non-intensive Study: Percentage of Participants With Complete Remission (CR) Including Negative Minimal Residual Disease (CRMRD-neg) | Day 1 up to maximum of 3 years | CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. CRMRDneg: CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC. |
| Secondary | Intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi) | Day 1 up to maximum of 2 years | CR was defined based on 2017 ELN recommendations. CR: MRD (positive or unknown), bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC less than (\<) 1.0\*10\^9/L; platelet count \<100 × 10\^9/L. CRi (included CR \[includes CRMRD-neg\]): not qualifying for CR, neutropenia \<1.0\*10\^9/L or platelets \<100\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods. |
| Secondary | Non-intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi) | Day 1 up to maximum of 3 years | CR was defined based on 2017 ELN recommendations. CR: MRD (positive or unknown), bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \<1.0\*10\^9/L; platelet count \<100 × 10\^9/L. CRi (included CR \[includes CRMRD-neg\]): not qualifying for CR, neutrophil \<0.5\*10\^9/L or platelets \<50\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods. |
| Secondary | Intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS) | Day 1 up to maximum of 2 years | MLFS was defined based on 2017 ELN recommendations. MLFS: MRD (positive or unknown), bone marrow blasts \<5%, no hematologic recovery required, marrow should not be aplastic, at least 200 cells enumerated or cellularity absence of extramedullary disease \>=10%, and absence of blasts with Auer rods. |
| Secondary | Non-intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS) | Day 1 up to maximum of 3 years | MLFS was defined based on 2017 ELN recommendations. MLFS: MRD (positive or unknown), bone marrow blasts \<5%, no hematologic recovery required, marrow should not be aplastic, at least 200 cells enumerated or cellularity absence of extramedullary disease \>=10%, and absence of blasts with Auer rods. |
| Secondary | Intensive Study: Percentage of Participants With Partial Remission (PR) | Day 1 up to maximum of 2 years | PR was defined based on 2017 ELN recommendations. PR: MRD (positive or unknown); bone marrow blasts - decrease to 5-25% and decrease of pre-treatment bone marrow blast percentage by at least 50%; neutrophil count \>=1.0\*10\^9/L; and platelets count \>=100\*10\^9/L. |
| Secondary | Non-intensive Study: Percentage of Participants With Partial Remission (PR) | Day 1 up to maximum of 3 years | PR was defined based on 2017 ELN recommendations. PR: MRD (positive or unknown); bone marrow blasts - decrease to 5-25% and decrease of pre-treatment bone marrow blast percentage by at least 50%; neutrophil count \>=1.0\*10\^9/L; and platelets count \>=100\*10\^9/L. |
| Secondary | Non-intensive Study: Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh) | Day 1 up to maximum of 3 years | CRh: MRD (positive or unknown); bone marrow blasts \<5%; assessed in non-intensive chemotherapy study only, not qualifying for CR, ie, both neutrophil \>=0.5\*10\^9/L and platelets \>=50\*10\^9/L must be met, but does not satisfy both neutrophils \>=1\*10\^9/L and platelets \>=100\*10\^9/L at the same time; absence of extramedullary disease; and absence of blasts with Auer rods. |
| Secondary | Intensive Study: Duration of Response (DoRi) | From date of first achieving CRi or better to the date of relapse after CRi or better or death due to any cause (maximum up to 2 years) | DoRi: only defined for participants who have ever achieved CRi or better (included CR as well) on study as the time from date of first achieving CRi or better to the date of relapse after CRi or better or death due to any cause. CRi: not qualifying for CR, neutropenia \<1.0\*10\^9/L or platelets \<100\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5 %; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. Participants last known to be alive who were free from relapse after CRi or better were censored at the date of last disease assessment that verifies their status. |
| Secondary | Non-intensive Study: Duration of Response (DoRi) or (DoRh) | From date of first achieving CRi/CRh or better to the date of relapse/disease progression after CRi/CRh or better or death due to any cause (maximum up to 3 years) | DoRi: only defined for participants who have ever achieved CRi or better (included CR and CRh) on study as the time from date of first achieving CRi or better to the date of relapse after CRi or better or death due to any cause. DoRh: participants who had ever achieved CRh or better (included CR) on study as the time from date of first achieving CRh or better to the date of disease progression, or relapse after CRh or better, or death due to any cause. CRi: not qualifying for CR, neutrophil \<0.5\*10\^9/L or platelets \<50\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods. CRh: MRD (positive or unknown); bone marrow blasts \<5%; assessed in non-intensive chemotherapy study only, not qualifying for CR, ie, both neutrophil \>=0.5\*10\^9/L and platelets \>=50\*10\^9/L must be met, but does not satisfy both neutrophils \>=1\*10\^9/L and platelets \>=100\*10\^9/L at the same time; absence of extramedullary disease; and absence of blasts with Auer rods. |
| Secondary | Non-intensive Study: Time to Response | From the date of randomization to the first documentation of response (CRi/CRh or better) (maximum up to 3 years) | TTRi:Participants who achieved CRi or better, as the time from date of randomization to first documentation of response(CRi or better).TTRh:Participants who achieved CRh or better, as the time from date of randomization to first documentation of response(CRh or better). CRi:not qualifying for CR, neutrophil\<0.5\*10\^9/L or platelets\<50\*10\^9, absence of extramedullary disease,absence of blasts with Auer rods. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5 %; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. CRh: MRD (positive or unknown); bone marrow blasts \<5%; assessed in non-intensive chemotherapy study only, not qualifying for CR, ie, both neutrophil \>=0.5\*10\^9/L and platelets \>=50\*10\^9/L must be met, but does not satisfy both neutrophils \>=1\*10\^9/L and platelets \>=100\*10\^9/L at the same time; absence of extramedullary disease; and absence of blasts with Auer rods. |
| Secondary | Intensive Study: Event-free Survival (EFS) | From the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first (maximum up to 2 years) | EFS: Time from the date of randomization to the date of treatment failure (TF), relapse from CR, or death from any cause, whichever comes first. TF was defined as failure to achieve CR during the induction cycle (including the re-induction cycle if there is one) and the event date for TF is the day of randomization. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. |
| Secondary | Non-intensive Study: Event-free Survival (EFS) | From the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first (maximum up to 3 years) | EFS: Time from the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first. TF was defined as failure to achieve CR during the induction cycle (including the re-induction cycle if there is one) and the event date for TF is the day of randomization. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. |
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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