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SY-1425 for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Acute Myeloid LeukemiaSY-1425 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether adding tamibarotene to the 2 other drugs helps people with this specific type of leukemia live longer.

Eligible Conditions
  • Acute Myeloid Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Uproleselan
1
SY-2101
1
TAS1440

Study Objectives

2 Primary · 14 Secondary · Reporting Duration: up to 3 years

Day 28
Part 1: Plasma Concentration of SY-1425
Plasma Exchange
Part 1: Plasma Concentration of tamibarotene
up to 3 years
Part 1: Number of Participants With Adverse Events
Part 1: Overall Response Rate (ORR)
Part 2: CR Rate
Part 2: CR/CRh Rate
Part 2: CR/CRi Rate
Part 2: Duration of CR
Part 2: Duration of CR/CRh
Part 2: Duration of CR/CRi
Part 2: Number of Participants With Adverse Events
Part 2: ORR
Part 2: Time to CR
Part 2: Time to CR/CRh
Part 2: Time to CR/CRi

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Uproleselan
1
SY-2101
1
TAS1440

Trial Design

7 Treatment Groups

Part 2: Venetoclax/Azacitidine
1 of 7
Part 1: SY-1425/Venetoclax/Azacitidine
1 of 7
Part 1: Tamibarotene/Venetoclax/Azacitidine
1 of 7
Part 2: SY-1425/Venetoclax/Azacitidine
1 of 7
Part 3: SY-1425/Venetoclax/Azacitidine
1 of 7
Part 2: Tamibarotene/Venetoclax/Azacitidine
1 of 7
Part 3: Tamibarotene/Venetoclax/Azacitidine
1 of 7

Active Control

Experimental Treatment

95 Total Participants · 7 Treatment Groups

Primary Treatment: SY-1425 · No Placebo Group · Phase 2

Part 1: SY-1425/Venetoclax/AzacitidineExperimental Group · 3 Interventions: Venetoclax, SY-1425, Azacitidine · Intervention Types: Drug, Drug, Drug
Part 1: Tamibarotene/Venetoclax/AzacitidineExperimental Group · 3 Interventions: Venetoclax, Azacitidine, Tamibarotene · Intervention Types: Drug, Drug, Drug
Part 2: SY-1425/Venetoclax/AzacitidineExperimental Group · 3 Interventions: Venetoclax, SY-1425, Azacitidine · Intervention Types: Drug, Drug, Drug
Part 3: SY-1425/Venetoclax/AzacitidineExperimental Group · 3 Interventions: Venetoclax, SY-1425, Azacitidine · Intervention Types: Drug, Drug, Drug
Part 2: Tamibarotene/Venetoclax/AzacitidineExperimental Group · 3 Interventions: Venetoclax, Azacitidine, Tamibarotene · Intervention Types: Drug, Drug, Drug
Part 3: Tamibarotene/Venetoclax/AzacitidineExperimental Group · 3 Interventions: Venetoclax, Azacitidine, Tamibarotene · Intervention Types: Drug, Drug, Drug
Part 2: Venetoclax/AzacitidineActiveComparator Group · 2 Interventions: Venetoclax, Azacitidine · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
FDA approved
Azacitidine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

Syros PharmaceuticalsLead Sponsor
5 Previous Clinical Trials
636 Total Patients Enrolled
Michael Kelly Executive Medical Director, MDStudy DirectorSyros Pharmaceuticals
Medical Director, MDStudy DirectorSyros Pharmaceuticals
67 Previous Clinical Trials
13,372 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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References

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