Tamibarotene Plus Venetoclax/Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Conditions

• Acute Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tamibarotene — DRUG
  Tamibarotene tablets will be administered per dose and schedule specified in the arm.
• Venetoclax — DRUG
  Venetoclax tablets will be administered per dose and schedule specified in the arm.
• Azacitidine — DRUG
  Azacitidine injection will be administered per dose and schedule specified in the arm.

Study Details

Tamibarotene is being studied as a treatment for participants with a type of leukemia called acute myeloid leukemia, or AML for short. Tamibarotene is being studied as a treatment for participants with AML whose cancer has a specific genetic abnormality characterized by the overexpression of the retinoic acid receptor alpha (RARA) gene. This genetic profile is found in about 3 of every 10 people with AML. During the trial, tamibarotene will be given with 2 other drugs that are already used together to treat people who have AML and who cannot start treatment with standard chemotherapy.

Key Dates

Start date

Aug 26, 2021

Status verified

Jan 2025

Primary completion

Aug 12, 2024

Completion

Aug 12, 2024

Study Design

Enrollment

66 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Tamibarotene/Venetoclax/Azacitidine
  Participants will receive the tamibarotene/venetoclax/azacitidine triplet combination as follows: Azacitidine (intravenously or subcutaneously) at 75 milligrams (mg)/square meter (m\^2) once daily, on Days 1 through 7 of each 28-day therapy cycle (per VIDAZA USPI). Alternative dosing of azacitidine (Days 1 through 5, 8, and 9) will be permitted throughout the study. Venetoclax (orally) daily on Days 1 through 28 per standard of care. Standard of care daily dosing is 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Day 3 and beyond. Tamibarotene 6 mg twice daily (BID) orally, on Days 8 through 28 of each 28-day therapy cycle. Tamibarotene will only be administered to participants who have been confirmed as RARA-positive.
• Experimental: Part 2: Tamibarotene/Venetoclax/Azacitidine
  Participants will receive the tamibarotene/venetoclax/azacitidine triplet combination at the dose and regimen selected in Part 1.
• Active Comparator: Part 2: Venetoclax/Azacitidine
  Participants will receive the venetoclax/azacitidine combination at the dose and regimen selected in Part 1.
• Experimental: Part 3: Tamibarotene/Venetoclax/Azacitidine
  Part 2 participants treated with venetoclax/azacitidine who experience progressive disease, relapse after initial CR or CRi response, or treatment failure may begin subsequent treatment in Part 3, where tamibarotene will be added to their regimen.

Primary Outcome Measure

Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 3 years ]

Locations (15)

Find similar trials in Duarte, CA

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