A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy.

Part of paid clinical trials in Portland, Oregon.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05155709
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • siremadlin — DRUG
    Siremadlin is a capsule taken orally once a day (QD) and comes in 10 mg, 20 mg and 30 mg strengths
  • venetoclax — DRUG
    Venetoclax is a tablet taken orally once a day (QD) and comes in 10 mg, 50 mg and 100 mg strengths.
  • azacitidine — DRUG
    Azacitidine is a powder for suspension for injection or powder for solution for infusion taken intravenously or subcutaneously comes in 100 mg but was administered according to standard local clinical practice.

Study Details

A study of siremadlin in combination with venetoclax plus azacitidine in adult participants with AML who are ineligible for chemotherapy. The primary purpose of this study was to assess whether siremadlin in combination with venetoclax plus azacitidine can enhance the clinical response in unfit AML participants without unacceptable levels of treatment-emergent toxicities.

Key Dates

Start date
May 17, 2022
Status verified
Apr 2026
Primary completion
Apr 17, 2024
Completion
Apr 17, 2024

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Adult participants with unfit AML who responded sub-optimally to standard of care
    Unfit adult participants with unfit AML who responded sub-optimally to at least 2 and not more than 4 cycles of first-line venetoclax plus azacitidine therapy. Siremadlin was adminstered at a dose of 20 mg QD which could be increased based on toxicities; venetoclax was administered at 400 mg once daily and azacitidine was administered at 75 mg/m\^2.
  • Experimental: Arm 2: Adult participants with newly diagnosed unfit AML with high risk clinical features
    Adult participants with unfit AML who were newly diagnosed and presenting with high-risk clinical features (which related to factors conferring to a low likelihood of response to venetoclax plus azacitidine) and with adverse genetic risk stratification (according to ELN 2022) (Except TP53 mutation positive participants). Siremadlin was administered at a dose of 20 mg QD which could be increased based on toxicities; venetoclax was administered at 400 mg once daily and azacitidine was administered at 75 mg/m\^2.

Primary Outcome Measure

Percentage of participants with Dose Limiting Toxicities (DLTs) as per investigator assessment reported during the first cycle (separately in Arm 1 & Arm 2) [ Time Frame: From Cycle 1 Day 1 to Cycle 1 Day 28 (28 days) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Oregon Health Sciences UniversityPortlandOregon97239-
Texas Oncology Sammons Cancer CenterDallasTexas78246-

Find similar trials in Portland, OR

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Oregon Health Sciences University· Portland, ORTexas Oncology Sammons Cancer Center· Dallas, TX

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