TriangleNCT05282459 · STUDY IN CONTEXT
Enasidenib in MDS &Non-proliferative Chronic Myelomonocytic Leukemia w/o IDH2 Mutation
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Clinical response was assessed as the number of participants achieving a hematological improvement - erythroid (HI-E). Participants were characterized and stratified as nontransfused (NTD), low-transfusion burden (LTB) and high-transfusion burden (HTB), with response defined as follows. * NTD = greater than or equal to 2 consecutive Hb measurements, greater than or equal to 1.5 g/dL for a period of minimum 8 week in an observation period of 16 to 24 week compared to the lowest mean of 2 Hb measurements * LTB = 0 units of RBC transfusions * HTB = greater than or equal to 4 unit or greater than or equal to 50% reduction in RBC transfusions
Toxicity was assessed as the number of related non-serious adverse events and related serious adverse events (SAEs) reported by dose level (Cohort A or Cohort B) for the 12-cycle treatment period plus follow-up.
Time to hematological improvement - erythroid (HI-E) was assessed as the time from first dose of enasidenib to the first observed hemoglobin response. Participants will be characterized and stratified as non-transfused (NTD), low-transfusion burden (LTB) and high-transfusion burden (HTB), with response defined as follows. * NTD = greater than or equal to 2 consecutive Hb measurements, greater than or equal to 1.5 g/dL for a period of minimum 8 week in an observation period of 16 to 24 week compared to the lowest mean of 2 Hb measurements * LTB = 0 units of RBC transfusions * HTB = greater than or equal to 4 unit or greater than or equal to 50% reduction in RBC transfusions
Duration of Hematological Improvement - Erythroid (HI-E) will be assessed as the time from recorded response to loss of response. Participants will be characterized and stratified as nontransfused (NTD), low-transfusion burden (LTB) and high-transfusion burden (HTB), with response defined as follows. NTD = greater than or equal to 2 consecutive Hb measurements, greater than or equal to 1.5 g/dL for a period of minimum 8 week in an observation period of 16 to 24 week compared to the lowest mean of 2 Hb measurements LTB = 0 units of RBC transfusions HTB = greater than or equal to 4 unit or greater than or equal to 50% reduction in RBC transfusions The outcome will be reported as the number of participants that achieve the response, a number without dispersion.
Clinical response for platelets was assessed as the number of participants achieving a hematological improvement - platelets (HI-P). Participants will be characterized and stratified as platelets \< or ≥ 20 x 10\^9/L, with response defined as follows. * \< 20 x 10\^9/L = increase in platelets from \< 20 x 10\^9/L to \> 20 x 10\^9/L AND by ≥ 100% * ≥ 20 x 10\^9/L = absolute increase in platelets of 30 x 10\^9/L The outcome will be reported as the number of participants that achieve the response, a number without dispersion.
Clinical response for neutrophils was assessed as the number of participants achieving a hematological improvement - neutrophils (HI-N). Response was defined as an absolute increase in neutrophils \> 0.5 × 10\^9/L that was also an increase of ≥ 100%.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- trial label
- Enasidenib in MDS &Non-proliferative Chronic Myelomonocytic Leukemia w/o IDH2 Mutation
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- outcome key
- om-0000
- source section id
- NCT05282459-om-0000
- source outcome index
- 0
- endpoint
- Clinical Response: Hematological Improvement - Erythroid (HI-E)
- endpoint definition
- Clinical response was assessed as the number of participants achieving a hematological improvement - erythroid (HI-E). Participants were characterized and stratified as nontransfused (NTD), low-transfusion burden (LTB) and high-transfusion burden (HTB), with response defined as follows. * NTD = greater than or equal to 2 consecutive Hb measurements, greater than or equal to 1.5 g/dL for a period of minimum 8 week in an observation period of 16 to 24 week compared to the lowest mean of 2 Hb measurements * LTB = 0 units of RBC transfusions * HTB = greater than or equal to 4 unit or greater than or equal to 50% reduction in RBC transfusions
- time origin
- 16 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- outcome key
- om-0001
- source section id
- NCT05282459-om-0001
- source outcome index
- 1
- endpoint
- Related Adverse Events
- endpoint definition
- Toxicity was assessed as the number of related non-serious adverse events and related serious adverse events (SAEs) reported by dose level (Cohort A or Cohort B) for the 12-cycle treatment period plus follow-up.
- time origin
- 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- outcome key
- om-0002
- source section id
- NCT05282459-om-0002
- source outcome index
- 2
- endpoint
- Time to Hematological Improvement - Erythroid (HI-E)
- endpoint definition
- Time to hematological improvement - erythroid (HI-E) was assessed as the time from first dose of enasidenib to the first observed hemoglobin response. Participants will be characterized and stratified as non-transfused (NTD), low-transfusion burden (LTB) and high-transfusion burden (HTB), with response defined as follows. * NTD = greater than or equal to 2 consecutive Hb measurements, greater than or equal to 1.5 g/dL for a period of minimum 8 week in an observation period of 16 to 24 week compared to the lowest mean of 2 Hb measurements * LTB = 0 units of RBC transfusions * HTB = greater than or equal to 4 unit or greater than or equal to 50% reduction in RBC transfusions
- time origin
- 16 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- No participants achieved Hematological Improvement - Erythroid (HI-E), and therefore no results could be calculated.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- outcome key
- om-0003
- source section id
- NCT05282459-om-0003
- source outcome index
- 3
- endpoint
- Duration of Hematological Improvement - Erythroid (HI-E)
- endpoint definition
- Duration of Hematological Improvement - Erythroid (HI-E) will be assessed as the time from recorded response to loss of response. Participants will be characterized and stratified as nontransfused (NTD), low-transfusion burden (LTB) and high-transfusion burden (HTB), with response defined as follows. NTD = greater than or equal to 2 consecutive Hb measurements, greater than or equal to 1.5 g/dL for a period of minimum 8 week in an observation period of 16 to 24 week compared to the lowest mean of 2 Hb measurements LTB = 0 units of RBC transfusions HTB = greater than or equal to 4 unit or greater than or equal to 50% reduction in RBC transfusions The outcome will be reported as the number of participants that achieve the response, a number without dispersion.
- time origin
- 16 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- No participants achieved Hematological Improvement - Erythroid (HI-E), and therefore no results could be calculated.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- outcome key
- om-0004
- source section id
- NCT05282459-om-0004
- source outcome index
- 4
- endpoint
- Clinical Response: Hematological Improvement - Platelets (HI-P)
- endpoint definition
- Clinical response for platelets was assessed as the number of participants achieving a hematological improvement - platelets (HI-P). Participants will be characterized and stratified as platelets \< or ≥ 20 x 10\^9/L, with response defined as follows. * \< 20 x 10\^9/L = increase in platelets from \< 20 x 10\^9/L to \> 20 x 10\^9/L AND by ≥ 100% * ≥ 20 x 10\^9/L = absolute increase in platelets of 30 x 10\^9/L The outcome will be reported as the number of participants that achieve the response, a number without dispersion.
- time origin
- 8 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- outcome key
- om-0005
- source section id
- NCT05282459-om-0005
- source outcome index
- 5
- endpoint
- Clinical Response: Hematological Improvement - Neutrophils (HI-N)
- endpoint definition
- Clinical response for neutrophils was assessed as the number of participants achieving a hematological improvement - neutrophils (HI-N). Response was defined as an absolute increase in neutrophils \> 0.5 × 10\^9/L that was also an increase of ≥ 100%.
- time origin
- 8 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Enasidenib Mesylat 100mg
- regimen
- Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 100 mg once daily.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05282459-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Enasidenib Mesylat 200mg
- regimen
- Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 200 mg once daily.
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05282459-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Enasidenib Mesylat 100mg
- regimen
- Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 100 mg once daily.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05282459-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Enasidenib Mesylat 200mg
- regimen
- Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 200 mg once daily.
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05282459-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Enasidenib Mesylat 100mg
- regimen
- Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 100 mg once daily.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05282459-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Enasidenib Mesylat 200mg
- regimen
- Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 200 mg once daily.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05282459-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Enasidenib Mesylat 100mg
- regimen
- Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 100 mg once daily.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05282459-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Enasidenib Mesylat 200mg
- regimen
- Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 200 mg once daily.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05282459-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Enasidenib Mesylat 100 mg
- regimen
- Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 100 mg once daily.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05282459-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Enasidenib Mesylat 200 mg
- regimen
- Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 200 mg once daily.
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05282459-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Enasidenib Mesylat 100 mg
- regimen
- Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 100 mg once daily.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05282459-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Enasidenib Mesylat 200 mg
- regimen
- Participants in this dose-escalation cohort self-administered enasidenib mesylate orally at a dose of 200 mg once daily.
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05282459-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- harm key
- EG000
- source section id
- NCT05282459-ae
- event group key
- EG000
- event group label
- Enasidenib Mesylat 100mg
- serious affected
- 3
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- Informed consent through 90 days after last dose, an average of 9 months
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-leukemia
- nct id
- NCT05282459
- harm key
- EG001
- source section id
- NCT05282459-ae
- event group key
- EG001
- event group label
- Enasidenib Mesylat 200mg
- serious affected
- 7
- serious at risk
- 14
- other affected
- 14
- other at risk
- 14
- frequency threshold
- 5
- collection period
- Informed consent through 90 days after last dose, an average of 9 months
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice