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NCT04752163 · OUTCOME

Event-free Survival

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
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
Up to the date of failure or death from any cause, approximately 2 years, 7 months

What was measured

Time from date of treatment start until the date of failure or death from any cause.

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

GroupSource count
Phase I (DS-1594b) Cohort 14
Phase I (DS-1594b) Cohort 24
Phase I (DS-1594b) Cohort 35
Phase I (DS-1594b) Cohort 43
Phase I (DS-1594b) Cohort 51
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 Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase I (DS-1594b) Cohort 11.8Not reported0.53.3Not reported
Phase I (DS-1594b) Cohort 20.7Not reported0.11.2Not reported
Phase I (DS-1594b) Cohort 31.2Not reported0.63.0Not reported
Phase I (DS-1594b) Cohort 42.6Not reported1.94.6Not reported
Phase I (DS-1594b) Cohort 50.8Not reported0.80.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        upper Limit
        3.3
        value
        1.8
      2. group Id
        OG001
        lower Limit
        0.1
        upper Limit
        1.2
        value
        0.7
      3. group Id
        OG002
        lower Limit
        0.6
        upper Limit
        3.0
        value
        1.2
      4. group Id
        OG003
        lower Limit
        1.9
        upper Limit
        4.6
        value
        2.6
      5. group Id
        OG004
        lower Limit
        0.8
        upper Limit
        0.8
        value
        0.8
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      value
      0
    units
    Participants
description
Time from date of treatment start until the date of failure or death from any cause.
dispersion Type
Full Range
groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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)
  7. 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)
  8. 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
MEDIAN
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 the date of failure or death from any cause, approximately 2 years, 7 months
title
Event-free Survival
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice