NCT03922100 · OUTCOME

Phase II - Number of Participants Who Achieved Composite Complete Remission (CRc) Rate i.e. Complete Remission (CR) + Complete Remission With Incomplete Hematologic Recovery (CRi).

Study of NMS-03592088 in Patients With Relapsed or Refractory AML or CMML · Source last updated 2026-03-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: At Screening; Day 1 of Cycle 2 and Cycle 3; and Day 1 at subsequent even cycle; up to End of Treatment visit (within 7 days of the final dose of study drug), up to 17 months

What was measured

CR = complete remission; CRc = composite complete remission rate; CRh = complete remission with partial hematologic recovery, CRi = complete remission with incomplete hematologic recovery; MLFS = morphologic leukemia free state; ORR = overall response rate; SD = stable disease Categories defined by the 2022 European LeukemiaNet (ELN) recommendations.

Analysis population: Patients Evaluable for Efficacy Analysis:This population included all enrolled participants in Phase 2 who were treated at RP2D \& had ≥1 hematologic assessment. Participants who had early death or withdrew before response assessment, or had technically suboptimal BM sample, were non-evaluable for response and excluded from efficacy dataset. For Cohort 1 and Cohort 2, only subset of subjects with FLT3-ITD mutation and no D835 mutation based on the central test were included in this population.

Groups in this outcome

Phase 2, Schedule B, Cohort 1:360+150 mg

Participants who had failed standard of care including Venetoclax and Gilteritining based therapies. NMS-03592088 was administered, on Cycle 1, at 360 mg/day (loading dose) for 5 consecutive days, followed by 150 mg/day (maintenance dose) for 23 consecutive days. The same maintenance dose (150 mg/day) was administered from Cycle 2 onwards.

Phase 2, Schedule B, Cohort 2: 360+150 mg

Participants who had failed standard of care. NMS-03592088 was administered, on Cycle 1, at 360 mg/day (loading dose) for 5 consecutive days, followed by 150 mg/day (maintenance dose) for 23 consecutive days. The same maintenance dose (150 mg/day) was administered from Cycle 2 onwards.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Phase 2, Schedule B, Cohort 1:360+150 mg	3
Phase 2, Schedule B, Cohort 2: 360+150 mg	9

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 2, Schedule B, Cohort 1:360+150 mg	0	Not reported	Not reported	Not reported	Not reported
Phase 2, Schedule B, Cohort 2: 360+150 mg	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
9
units
Participants

description

groups

description
Participants who had failed standard of care including Venetoclax and Gilteritining based therapies. NMS-03592088 was administered, on Cycle 1, at 360 mg/day (loading dose) for 5 consecutive days, followed by 150 mg/day (maintenance dose) for 23 consecutive days. The same maintenance dose (150 mg/day) was administered from Cycle 2 onwards.
id
OG000
title
Phase 2, Schedule B, Cohort 1:360+150 mg
description
Participants who had failed standard of care. NMS-03592088 was administered, on Cycle 1, at 360 mg/day (loading dose) for 5 consecutive days, followed by 150 mg/day (maintenance dose) for 23 consecutive days. The same maintenance dose (150 mg/day) was administered from Cycle 2 onwards.
id
OG001
title
Phase 2, Schedule B, Cohort 2: 360+150 mg

param Type

COUNT_OF_PARTICIPANTS

population Description

Patients Evaluable for Efficacy Analysis:This population included all enrolled participants in Phase 2 who were treated at RP2D \& had ≥1 hematologic assessment. Participants who had early death or withdrew before response assessment, or had technically suboptimal BM sample, were non-evaluable for response and excluded from efficacy dataset. For Cohort 1 and Cohort 2, only subset of subjects with FLT3-ITD mutation and no D835 mutation based on the central test were included in this population.

reporting Status

POSTED

time Frame

At Screening; Day 1 of Cycle 2 and Cycle 3; and Day 1 at subsequent even cycle; up to End of Treatment visit (within 7 days of the final dose of study drug), up to 17 months

title

Phase II - Number of Participants Who Achieved Composite Complete Remission (CRc) Rate i.e. Complete Remission (CR) + Complete Remission With Incomplete Hematologic Recovery (CRi).

type

PRIMARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice