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NCT04752163 · OUTCOME

Number of Participants With Complete Remission (CR) and Complete Remission With Partial Hematologic Recover (CRh)With DS-1594b Monotherapy in (Phase II, Cohort A)

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
3 months

What was measured

AML Participants: (CR) is No circulating blasts, Neutrophils \> 1.0 x 10 \^ 9/L OR Platelet Count \> 100 x 10 \^ 9/L, Bone marrow aspirate and biopsy \<5% blasts, No Auer rods, No extramedullary leukemia. (CRh) is defined No circulating blasts, Neutrophils \>/= 0.5 x 10 \^ 9/L, Platelet Count \>/= 50 x 10 \^ 9/L, Bone marrow aspirate and biopsy \<5% blasts, No Auer rods. ALL Participants: (CR) is No circulating lymphoblast or extramedullary disease, No lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement. Trilineage hematopoiesis (TLH) and \<5% blasts, Neutrophil count \> 1.0 x 10 \^ 9/L, platelet count \> 100 x 10 \^ 9/L, No recurrence for 4 weeks. (CRh) No circulating lymphoblast or extramedullary disease, No lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement. Trilineage hematopoiesis (TLH) and \<5% blasts, Neutrophil count \>/= 0.5 x 10 \^ 9/L, \>/= 50 x 10 \^ 9/L, No recurrence for 4 weeks.

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 10
Phase I (DS-1594b) Cohort 20
Phase I (DS-1594b) Cohort 30
Phase I (DS-1594b) Cohort 40
Phase I (DS-1594b) Cohort 50
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

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      value
      0
    units
    Participants
description
AML Participants: (CR) is No circulating blasts, Neutrophils \> 1.0 x 10 \^ 9/L OR Platelet Count \> 100 x 10 \^ 9/L, Bone marrow aspirate and biopsy \<5% blasts, No Auer rods, No extramedullary leukemia. (CRh) is defined No circulating blasts, Neutrophils \>/= 0.5 x 10 \^ 9/L, Platelet Count \>/= 50 x 10 \^ 9/L, Bone marrow aspirate and biopsy \<5% blasts, No Auer rods. ALL Participants: (CR) is No circulating lymphoblast or extramedullary disease, No lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement. Trilineage hematopoiesis (TLH) and \<5% blasts, Neutrophil count \> 1.0 x 10 \^ 9/L, platelet count \> 100 x 10 \^ 9/L, No recurrence for 4 weeks. (CRh) No circulating lymphoblast or extramedullary disease, No lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement. Trilineage hematopoiesis (TLH) and \<5% blasts, Neutrophil count \>/= 0.5 x 10 \^ 9/L, \>/= 50 x 10 \^ 9/L, No recurrence for 4 weeks.
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)
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
3 months
title
Number of Participants With Complete Remission (CR) and Complete Remission With Partial Hematologic Recover (CRh)With DS-1594b Monotherapy in (Phase II, Cohort A)
type
PRIMARY

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

Preserved source evidence · Not medical advice