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Protein Binding Inhibitor

DS-1594b with or without additional treatments for Leukemia

Phase 1 & 2
Waitlist Available
Led By Naval G Daver
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is studying DS-1594b with or without azacitidine, venetoclax, or mini-HCVD to treat patients with acute myeloid leukemia or acute lymphoblastic leukemia that has come back or not responded to treatment.

Eligible Conditions
  • Myelodysplastic Syndromes
  • Acute Lymphoblastic Leukemia
  • Acute Myelogenous Leukemia
  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic Syndrome
  • Blood Cancers
  • Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CR+ complete remission with incomplete hematologic recovery (CRi) rate of DS-1594b in combination with mini-HCVD in R/R ALL with MLLr
CR+CRh rate of DS1594b in combination with azacitidine and venetoclax in R/R MLLr or R/R NPM1m AML (Phase II, Cohort C)
CR+CRh rate of DS1594b in combination with mini-HCVD in R/R ALL with MLLr (Phase II, Cohort D)
+5 more
Secondary outcome measures
Composite CR (CRc) rate
Duration of response
Event-free survival
+9 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Phase I (DS-1594b)Experimental Treatment1 Intervention
Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity.
Group II: Food-Effect (DS-1594b)Experimental Treatment1 Intervention
Patients receive DS-1594b PO BID on days 1-8 within 30 minutes after eating a standard meal and PO BID on days 9-15 under fasting conditions in the absence of disease progression or unacceptable toxicity.
Group III: Drug-Drug Interaction (DS-1594b, posaconazole, voriconazole)Experimental Treatment3 Interventions
Patients receive DS-1594b PO BID on days 1-8 and 19-28, and posaconazole PO BID on day 9 and QD on days 10-18 or voriconazole PO BID on days 9-18 in the absence of disease progression or unacceptable toxicity.
Group IV: Cohort D (DS-1594b, mini-HCVD)Experimental Treatment11 Interventions
Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description.
Group V: Cohort C (DS-1594b, venetoclax, azacitidine)Experimental Treatment3 Interventions
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.
Group VI: Cohort A and B (DS-1594b)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310
Dexamethasone
2007
Completed Phase 4
~2590
Cyclophosphamide
1995
Completed Phase 3
~3770
Filgrastim
2000
Completed Phase 3
~3670
Leucovorin
2005
Completed Phase 4
~5730
Mesna
2003
Completed Phase 2
~1380
DS-1594b
2021
Completed Phase 2
~20
Azacitidine
2012
Completed Phase 3
~1440
Methotrexate
2013
Completed Phase 4
~3800
Posaconazole
2018
Completed Phase 4
~4180
Prednisone
2014
Completed Phase 4
~2370
Rituximab
1999
Completed Phase 4
~1880
Venetoclax
2019
Completed Phase 3
~1990
Vincristine
2003
Completed Phase 4
~2910
Voriconazole
2008
Completed Phase 4
~5740

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,785 Total Patients Enrolled
166 Trials studying Myelodysplastic Syndromes
10,607 Patients Enrolled for Myelodysplastic Syndromes
Naval G DaverPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
168 Total Patients Enrolled
Naval G Daver, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
146 Total Patients Enrolled

Media Library

DS-1594b (Protein Binding Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04752163 — Phase 1 & 2
Myelodysplastic Syndromes Research Study Groups: Cohort A and B (DS-1594b), Cohort C (DS-1594b, venetoclax, azacitidine), Cohort D (DS-1594b, mini-HCVD), Drug-Drug Interaction (DS-1594b, posaconazole, voriconazole), Food-Effect (DS-1594b), Phase I (DS-1594b)
Myelodysplastic Syndromes Clinical Trial 2023: DS-1594b Highlights & Side Effects. Trial Name: NCT04752163 — Phase 1 & 2
DS-1594b (Protein Binding Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04752163 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
2021. "DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04752163.
~4 spots leftby Apr 2025
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