Active Not Recruiting PHASE2 INTERVENTIONAL 2-arm NCT04802161

Comparing the Addition of an Anti-Cancer Drug, Pomalidomide, to the Usual Chemotherapy Treatment (Daunorubicin and Cytarabine Liposome) in Newly Diagnosed Acute Myeloid Leukemia With Myelodysplastic Syndrome-Related Changes

Randomized Phase 2 Study of Daunorubicin and Cytarabine Liposome + Pomalidomide Versus Daunorubicin and Cytarabine Liposome in Newly Diagnosed AML With MDS-Related Changes

Sponsor: National Cancer Institute (NCI)

Conditions Acute Myeloid Leukemia Acute Myeloid Leukemia Post Cytotoxic Therapy Acute Myeloid Leukemia With Multilineage Dysplasia Chronic Myelomonocytic Leukemia Myelodysplastic Syndrome Myeloproliferative Neoplasm

Interventions Biospecimen Collection Bone Marrow Aspiration and Biopsy Liposome-encapsulated Daunorubicin-Cytarabine Pomalidomide

Updated 28 times since 2021 Last updated: Dec 9, 2025 Started: Aug 24, 2022 Primary completion: Nov 21, 2024 Completion: Apr 25, 2026

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Acute Myeloid Leukemia and Acute Myeloid Leukemia Post Cytotoxic Therapy, this trial is ongoing. The trial is conducted by National Cancer Institute (NCI) and has accumulated 28 data snapshots since 2022. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

28 versions recorded

Jan 2026 — Present [monthly]

Active Not Recruiting PHASE2
Jun 2025 — Jan 2026 [monthly]

Active Not Recruiting PHASE2
May 2025 — Jun 2025 [monthly]

Active Not Recruiting PHASE2
Apr 2025 — May 2025 [monthly]

Active Not Recruiting PHASE2
Mar 2025 — Apr 2025 [monthly]

Active Not Recruiting PHASE2

Status: Suspended → Active Not Recruiting

▶ Show 23 earlier versions

Jan 2025 — Mar 2025 [monthly]

Suspended PHASE2
Sep 2024 — Jan 2025 [monthly]

Suspended PHASE2

Status: Recruiting → Suspended
Aug 2024 — Sep 2024 [monthly]

Recruiting PHASE2
Jul 2024 — Aug 2024 [monthly]

Recruiting PHASE2
Jun 2024 — Jul 2024 [monthly]

Recruiting PHASE2
Mar 2024 — Jun 2024 [monthly]

Recruiting PHASE2
Feb 2024 — Mar 2024 [monthly]

Recruiting PHASE2
Jan 2024 — Feb 2024 [monthly]

Recruiting PHASE2
Dec 2023 — Jan 2024 [monthly]

Recruiting PHASE2
Nov 2023 — Dec 2023 [monthly]

Recruiting PHASE2
Oct 2023 — Nov 2023 [monthly]

Recruiting PHASE2
Sep 2023 — Oct 2023 [monthly]

Recruiting PHASE2
Jul 2023 — Sep 2023 [monthly]

Recruiting PHASE2
Apr 2023 — Jul 2023 [monthly]

Recruiting PHASE2
Feb 2023 — Apr 2023 [monthly]

Recruiting PHASE2
Dec 2022 — Feb 2023 [monthly]

Recruiting PHASE2
Sep 2022 — Dec 2022 [monthly]

Recruiting PHASE2

Status: Suspended → Recruiting
Jul 2022 — Sep 2022 [monthly]

Suspended PHASE2
Jan 2022 — Jul 2022 [monthly]

Suspended PHASE2
Nov 2021 — Jan 2022 [monthly]

Suspended PHASE2

Status: Not Yet Recruiting → Suspended
Sep 2021 — Nov 2021 [monthly]

Not Yet Recruiting PHASE2
May 2021 — Sep 2021 [monthly]

Not Yet Recruiting PHASE2
Apr 2021 — May 2021 [monthly]

Not Yet Recruiting PHASE2

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

National Cancer Institute (NCI)

Data source: National Cancer Institute (NCI)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Atlanta, United States , Baltimore, United States , Chapel Hill, United States , Charlottesville, United States , Cincinnati, United States , Columbus, United States , Kansas City, United States , New York, United States , West Chester, United States , Westwood, United States and 1 more location