Who is sponsoring NCT03701295?

NCT03701295 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT03701295?

Interventions in NCT03701295: Azacitidine, Pinometostat.

What condition does NCT03701295 study?

NCT03701295 studies Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-MLL, Leukemia Cutis, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia.

Is NCT03701295 still recruiting?

NCT03701295 is currently completed. Last updated 18 October 2023.

Are results published for NCT03701295?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-10-18 · How we verify

NCT03701295

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pinometostat and Azacitidine in Treating Patients With Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia With 11q23 Rearrangement

Completed Phase 1, PHASE2 Results posted Last updated 18 October 2023

What this trial tests

Phase 1, PHASE2 trial testing Azacitidine in Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-MLL in 1 participant. Completed in 12 January 2021.

Timeline

6 March 2020

Primary endpoint
8 December 2020

12 January 2021

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	6 March 2020
Primary completion	8 December 2020
Estimated completion	12 January 2021
Sites	1 location across United States

Drugs / interventions tested

Azacitidine (azacitidine) — full drug profile →
Pinometostat — full drug profile →

Conditions studied

Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-MLL — all drugs for Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-MLL →
Leukemia Cutis — all drugs for Leukemia Cutis →
Recurrent Acute Myeloid Leukemia — all drugs for Recurrent Acute Myeloid Leukemia →
Refractory Acute Myeloid Leukemia — all drugs for Refractory Acute Myeloid Leukemia →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-MLL or Leukemia Cutis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase Ib/II trial studies the side effects and best dose of pinometostat when given together with azacitidine and to see how well it works in treating patients with acute myeloid leukemia that has come back (relapsed), does not respond to treatment (refractory), or is newly diagnosed, with an 11q23 rearrangement. Pinometostat and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting epigenetic regulators for cancer therapy: mechanisms and advances in clinical trials.
Cheng Y, He C, Wang M, Ma X, et al · · 2019 · cited 760× · PMID 31871779 · DOI 10.1038/s41392-019-0095-0
Tumor biomarkers for diagnosis, prognosis and targeted therapy.
Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
Epigenetics and beyond: targeting writers of protein lysine methylation to treat disease.
Bhat KP, Ümit Kaniskan H, Jin J, Gozani O. · · 2021 · cited 181× · PMID 33469207 · DOI 10.1038/s41573-020-00108-x
Recent advances in targeted therapies in acute myeloid leukemia.
Bhansali RS, Pratz KW, Lai C. · · 2023 · cited 151× · PMID 36966300 · DOI 10.1186/s13045-023-01424-6
Epigenetics-targeted drugs: current paradigms and future challenges.
Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0
Dysregulated haematopoietic stem cell behaviour in myeloid leukaemogenesis.
Yamashita M, Dellorusso PV, Olson OC, Passegué E. · · 2020 · cited 128× · PMID 32415283 · DOI 10.1038/s41568-020-0260-3
Recent developments in epigenetic cancer therapeutics: clinical advancement and emerging trends.
Nepali K, Liou JP. · · 2021 · cited 122× · PMID 33840388 · DOI 10.1186/s12929-021-00721-x
Novel therapy in Acute myeloid leukemia (AML): moving toward targeted approaches.
Winer ES, Stone RM. · · 2019 · cited 92× · PMID 31321011 · DOI 10.1177/2040620719860645

Verify or expand the search:

Other trials of Azacitidine

Trials testing the same drug.

NCT07508982 — Phase1b/2 Trial Of AZA + APG1252 In Patients With High-Risk AML · Phase 1, PHASE2 · not yet recruiting
NCT05554419 — Testing the Use of Combination Therapy in Patients With Persistent Low Level Acute Myeloid Leukemia Following Initial Tr · Phase 2 · not yet recruiting
NCT07490288 — Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML · NA · not yet recruiting
NCT07469046 — VAH vs VA in Newly Diagnosed Elderly AML · Phase 3 · not yet recruiting
NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I · Phase 2 · recruiting

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03701295 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 18 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03701295.

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