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NCT04752163 · OUTCOME

Overall 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 death or last follow-up, approximately 2 years, 7 months

What was measured

Estimated using the Kaplan-Meier method.From the date of the treatment start to the date of death or to the date of last follow-up if patients are alive at the time of data collection

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 14.3Not reported0.56.7Not reported
Phase I (DS-1594b) Cohort 21.9Not reported0.14.0Not reported
Phase I (DS-1594b) Cohort 32.3Not reported1.18.5Not reported
Phase I (DS-1594b) Cohort 46.2Not reported5.56.9Not reported
Phase I (DS-1594b) Cohort 57.2Not reported7.27.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        upper Limit
        6.7
        value
        4.3
      2. group Id
        OG001
        lower Limit
        0.1
        upper Limit
        4.0
        value
        1.9
      3. group Id
        OG002
        lower Limit
        1.1
        upper Limit
        8.5
        value
        2.3
      4. group Id
        OG003
        lower Limit
        5.5
        upper Limit
        6.9
        value
        6.2
      5. group Id
        OG004
        lower Limit
        7.2
        upper Limit
        7.2
        value
        7.2
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
Estimated using the Kaplan-Meier method.From the date of the treatment start to the date of death or to the date of last follow-up if patients are alive at the time of data collection
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 death or last follow-up, approximately 2 years, 7 months
title
Overall Survival
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice