A Biomarker-Directed Phase 2 Trial of Tamibarotene (SY-1425) in Participants With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Syros Pharmaceuticals
Study ID
NCT02807558
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tamibarotene — DRUG
    Administered as oral tablets
  • Azacitidine — DRUG
    Administered via intravenous (IV) or subcutaneous (SC) infusion
  • Daratumumab — DRUG
    Administered via IV infusion

Study Details

The purpose of this study is to determine the activity of tamibarotene in participants with relapsed/refractory (R/R) AML (administered as a monotherapy or in combination with azacitidine), R/R higher-risk MDS (HR-MDS) (administered as a monotherapy or in combination with daratumumab), newly diagnosed treatment naïve AML participants who are unlikely to tolerate standard intensive chemotherapy (administered as a monotherapy or in combination with azacitidine), or lower-risk MDS (LR-MDS) (administered as a monotherapy).

Key Dates

Start date
Sep 20, 2016
Status verified
Nov 2024
Primary completion
Jan 25, 2023
Completion
Jan 25, 2023

Study Design

Enrollment
155 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: R/R Non-APL AML or R/R HR-MDS: Tamibarotene Monotherapy
    Participants with R/R non-APL AML or R/R HR-MDS will receive tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
  • Experimental: Newly Diagnosed Non-APL AML: Tamibarotene Monotherapy
    Newly diagnosed, treatment-naive participants with non-APL AML who were unlikely to tolerate standard intensive chemotherapy will receive tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
  • Experimental: Newly Diagnosed Non-APL AML: Tamibarotene and Azacitidine
    Newly diagnosed, treatment-naive participants with non-APL AML who are unlikely to tolerate standard intensive chemotherapy will receive tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.
  • Experimental: LR-MDS: Tamibarotene Monotherapy
    Participants with transfusion-dependent LR-MDS without the del 5q abnormality who are refractory to erythropoietin (EPO) treatment or unlikely to respond to EPO treatment will receive tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 1-28 of a 28-day cycle.
  • Experimental: R/R non-APL AML or R/R HR-MDS: Tamibarotene and Daratumumab
    Participants with R/R non-APL AML or R/R HR-MDS will receive tamibarotene at 6 mg/m\^2/day in 2 divided doses during a 7-day lead-in and on Days 1-28 of a 28-day cycle. Participants will also receive daratumumab at 16 mg/kg starting on Cycle 1 Day 1 once weekly for 8 weeks, followed by dosing every 2 weeks for 16 weeks, followed by dosing every 4 weeks.
  • Experimental: R/R non-APL AML: Tamibarotene and Azacitidine
    Participants with R/R non-APL AML will receive tamibarotene at 6 mg/m\^2/day in 2 divided doses on Days 8-28 of a 28-day cycle, and azacitidine at 75 mg/m\^2 once daily on Days 1-7 of a 28-day cycle.

Primary Outcome Measure

Overall Response Rate (ORR) in Biomarker Positive AML or HR-MDS Participants Treated With Tamibarotene Monotherapy or in Combination With Azacitidine [ Time Frame: Up to 48 months ]

Locations (14)

FacilityCityStateZIPSite coordinators
-HartfordConnecticut--
-MiamiFlorida--
-Iowa CityIowa--
-BostonMassachusetts--
-Ann ArborMichigan--
-New YorkNew York--
-RochesterNew York--
-DurhamNorth Carolina--
-ClevelandOhio--
-PortlandOregon--
-AllentownPennsylvania--
-PittsburghPennsylvania--
-NashvilleTennessee--
-HoustonTexas--

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