Venetoclax and Azacitidine for Treatment of Therapy Related or Secondary Myelodysplastic Syndrome

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Uma Borate
Study ID
NCT05379166
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Secondary Myelodysplastic Syndrome
  • Therapy-Related Myelodysplastic Syndrome

Eligibility Criteria

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

Interventions

  • Azacitidine — DRUG
    Given IV
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Venetoclax — DRUG
    Given PO

Study Details

This phase II trial studies the effect of venetoclax and azacitidine in treating patients with therapy related or secondary myelodysplastic syndrome. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax in combination with azacitidine may work better in treating patients with therapy related or secondary myelodysplastic syndrome.

Key Dates

Start date
Jun 23, 2022
Status verified
May 2026
Primary completion
Jan 27, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
33 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (venetoclax, azacitidine)
    Patients receive venetoclax PO QD on days 1-14 and azacitidine IV over 10-40 minutes on days 1-7 or days 1-5 of week 1 and days 1 and 2 of week 2. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Complete remission (CR) [ Time Frame: At the end of Cycle 4 (each cycle is 28 days) or earlier based on bone marrow results ]

Locations (3)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Oregon Health & Science UniversityPortlandOregon97239-
University of Texas Southwestern Medical CenterDallasTexas75390-

Find similar trials in Columbus, OH

By research site
Ohio State University Comprehensive Cancer Center· Columbus, OHOregon Health & Science University· Portland, ORUniversity of Texas Southwestern Medical Center· Dallas, TX

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