NCT04752163 · OUTCOME

Participants With Morphologic Leukemia-free State (MLFS)

DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia · Source last updated 2025-05-23

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: Up to 2 years

What was measured

AML Participants: Bone marrow \< 5% myeloblasts, no auer rods, no extramedullary leukemia, neutrophil or platelet recovery is not required.

Analysis population: Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

Groups in this outcome

Phase I (DS-1594b) Cohort 1

Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO

Phase I (DS-1594b) Cohort 2

Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO

Phase I (DS-1594b) Cohort 3

Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO

Phase I (DS-1594b) Cohort 4

Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO

Phase I (DS-1594b) Cohort 5

Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO

Phase 2 Cohort A and B (DS-1594b)

Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO

Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine)

Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO

Phase 2 Cohort D (DS-1594b, Mini-HCVD)

Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV

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 I (DS-1594b) Cohort 1	4
Phase I (DS-1594b) Cohort 2	4
Phase I (DS-1594b) Cohort 3	5
Phase I (DS-1594b) Cohort 4	3
Phase I (DS-1594b) Cohort 5	4
Phase 2 Cohort A and B (DS-1594b)	0
Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine)	0
Phase 2 Cohort D (DS-1594b, Mini-HCVD)	0

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Phase I (DS-1594b) Cohort 1	Not reported	Not reported	Not reported	Not reported
Phase I (DS-1594b) Cohort 2	Not reported	Not reported	Not reported	Not reported
Phase I (DS-1594b) Cohort 3	Not reported	Not reported	Not reported	Not reported
Phase I (DS-1594b) Cohort 4	Not reported	Not reported	Not reported	Not reported
Phase I (DS-1594b) Cohort 5	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0

denoms

counts
group Id
OG000
value
4
group Id
OG001
value
4
group Id
OG002
value
5
group Id
OG003
value
3
group Id
OG004
value
4
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
units
Participants

description

AML Participants: Bone marrow \< 5% myeloblasts, no auer rods, no extramedullary leukemia, neutrophil or platelet recovery is not required.

groups

description
Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO
id
OG000
title
Phase I (DS-1594b) Cohort 1
description
Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO
id
OG001
title
Phase I (DS-1594b) Cohort 2
description
Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO
id
OG002
title
Phase I (DS-1594b) Cohort 3
description
Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO
id
OG003
title
Phase I (DS-1594b) Cohort 4
description
Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO
id
OG004
title
Phase I (DS-1594b) Cohort 5
description
Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO
id
OG005
title
Phase 2 Cohort A and B (DS-1594b)
description
Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO
id
OG006
title
Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine)
description
Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV
id
OG007
title
Phase 2 Cohort D (DS-1594b, Mini-HCVD)

param Type

COUNT_OF_PARTICIPANTS

population Description

Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

reporting Status

POSTED

time Frame

Up to 2 years

title

Participants With Morphologic Leukemia-free State (MLFS)

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice