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NCT04817241ACTIVE_NOT_RECRUITINGanonymous

Clinical Evaluation of ASTX727 in Combination With Venetoclax All-Oral Therapy vs Standard of Care Cytarabine and Anthracycline Induction Chemotherapy for Younger FLT3WT Patients With ELN High- Risk Acute Myeloid Leukemia

Sponsor

Source record

National Cancer Institute (NCI)

Phase

Source record

Phase 1/2

Modality

AI-normalized

small molecule

Target

AI-normalized

BCL-2 and DNA methylation pathways

Indication / condition

AI-normalized

Acute Myeloid Leukemia

Intervention

Source record

Biospecimen Collection, Bone Marrow Aspiration and Biopsy, Cytarabine, Daunorubicin, Decitabine and Cedazuridine, Venetoclax

Source & freshness

Source record

NCT ID

NCT04817241

Original source

ClinicalTrials.gov

Source last updated

Nov 10, 2025

Ingested at

Jun 17, 2026

Internal sync

Jun 17, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT04817241

Title

Clinical Evaluation of ASTX727 in Combination With Venetoclax All-Oral Therapy vs Standard of Care Cytarabine and Anthracycline Induction Chemotherapy for Younger FLT3WT Patients With ELN High- Risk Acute Myeloid Leukemia

Sponsor

National Cancer Institute (NCI)

Status

ACTIVE_NOT_RECRUITING

Phase

Phase 1/2

Condition raw

Acute Myeloid Leukemia

Condition normalized

Acute Myeloid Leukemia

Modality raw

small molecule

Modality normalized

small molecule

Target raw

BCL-2 and DNA methylation pathways

Target normalized

BCL-2 and DNA methylation pathways

Interventions

Biospecimen Collection, Bone Marrow Aspiration and Biopsy, Cytarabine, Daunorubicin, Decitabine and Cedazuridine, Venetoclax

Public preview

Source record

The clinical trial evaluates ASTX727 (decitabine and cedazuridine) in combination with venetoclax for younger patients with high-risk FLT3 wild-type acute myeloid leukemia (AML). This all-oral therapy aims to provide a less invasive treatment option compared to standard intravenous chemotherapy (cytarabine and daunorubicin). The potential for improved patient compliance and outcomes could position this combination as a competitive alternative in the AML treatment landscape, particularly for younger patients. The trial's focus on high-risk populations aligns with current market trends emphasizing personalized and targeted therapies. If successful, this combination could capture significant market share, particularly as the demand for effective AML treatments continues to rise. Stakeholders should monitor the trial's progress closely, as positive results may lead to expedited regulatory pathways and partnerships with larger pharmaceutical entities.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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