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A Study for Oral SY-2101 for Participants With Acute Promyelocytic Leukemia

NCT04996030 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-01-23

No results posted yet for this study

Summary

SY-2101 is being studied as a treatment for participants with a type of leukemia called acute promyelocytic leukemia (APL). SY-2101 is an oral formulation of a drug called arsenic trioxide (ATO). ATO is already used to treat APL in a formulation that is given as an intravenous (IV) infusion (through a needle in the arm). SY-2101 is a formulation of ATO that is taken orally (by mouth).

This trial will include participants with APL in remission, who are receiving standard of care (SOC) treatment with all-trans-retinoic acid (ATRA) and IV ATO, during the consolidation phase of chemotherapy or within the past 6 months. The participants in this trial will receive continued treatment with ATO and ATRA to help keep their cancer from coming back. There will be some weeks when participants receive IV ATO and others when they receive SY-2101 (ATO taken orally). Participants with high-risk APL may be eligible for part 1 or 4 of the study for the 6 months following completion of their standard of care ATRA and ATO treatment.

Conditions

  • Acute Promyelocytic Leukemia

Interventions

DRUG

SY-2101

SY-2101 will be administered per dose and schedule specified in arm description.

DRUG

Arsenic Trioxide

IV ATO will be administered per dose and schedule specified in arm description.

Sponsors & Collaborators

  • Syros Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Medical Director, MD · Syros Pharmaceuticals Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-17
Primary Completion
2024-01-03
Completion
2024-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04996030 on ClinicalTrials.gov