azacitidine

P1/2, N=59, Recruiting, Novartis Pharmaceuticals | N=27 --> 59 | Trial completion date: Apr 2027 --> Aug 2024 | Trial primary completion date: Nov 2024 --> Jul 2024 | Active, not recruiting --> Recruiting

P1/2, N=29, Active, not recruiting, University of Colorado, Denver | Trial primary completion date: Apr 2024 --> Dec 2024

P2, N=70, Recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2028 --> Feb 2028

P2, N=90, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Mar 2026 --> Jul 2024 | Trial primary completion date: Mar 2026 --> Jul 2024

Cell lines were treated with SAHA, 5-Azacytidine, GSK-126, and PTC-209 individually and then RSM was used to find most effective combinations. Results showed that optimized combinations significantly reduce cell survival and induce cell cycle arrest and apoptosis in both cell lines. Expression of cyclin B1 and cyclin D1 were decreased while caspase3 increased expression.

P1, N=35, Completed, Washington University School of Medicine | Active, not recruiting --> Completed

P1, N=14, Active, not recruiting, Novartis Pharmaceuticals | Phase classification: P1/2 --> P1

P1, N=22, Not yet recruiting, M.D. Anderson Cancer Center

P2, N=60, Recruiting, The First Affiliated Hospital of Soochow University

P=N/A, N=30, Not yet recruiting, Peking University People's Hospital

P3; Active, not recruiting --> Completed

P3, N=486, Not yet recruiting, Ascentage Pharma Group Inc.

P1/2, N=180, Not yet recruiting, Akeso

P=N/A, N=184, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China

P3, N=316, Not yet recruiting, Hutchmed

FLT3 inhibitors, gemtuzumab ozogamicin, and CPX-351 have been shown to improve outcomes for specific subsets of patients. Venetoclax (VEN) with a hypomethylating agent (HMA) is the standard-of-care frontline regimen for most older patients, except perhaps for those with an IDH1 mutation where ivosidenib with azacitidine may also be considered...This article focuses on recent updates and ongoing challenges in the management of AML, with a particular focus on the ongoing challenge of secondary AML and considerations regarding the selection of initial therapy in younger patients. An overview of common side effects and toxicities associated with targeted therapies is also presented here, along with recommended strategies to mitigate these risks.

P2, N=120, Not yet recruiting, OncoVerity, Inc.

P2, N=20, Completed, The First Affiliated Hospital of Soochow University | Recruiting --> Completed | Trial completion date: Jun 2025 --> Apr 2024 | Trial primary completion date: Jun 2023 --> Apr 2024

Finally, we present clinical evidence showing that BM myeloid cells from higher risk MDS and AML patients have the potential to bind E-selectin, and these cells are more abundant in 5-azacitidine-non-responsive patients. The collective data provide a strong rationale to evaluate 5-azacitidine in combination with the E-selectin antagonist, uproleselan, in this patient population.

P2, N=53, Recruiting, Joshua Zeidner | Not yet recruiting --> Recruiting

Recent evidence also indicates that RAS mutations drive resistance to targeted therapies, particularly FLT3, IDH1/2, or JAK2 inhibitors, as well as the venetoclax-azacitidine combination. The success of direct RAS inhibitors in patients with solid tumors has brought renewed optimism that this progress will be translated to patients with hematologic malignancies. In this review, we highlight key insights on RAS mutations across myeloid malignancies from the past decade, including their prevalence and distribution, cooperative genetic events, clonal architecture and dynamics, prognostic implications, and therapeutic targeting.

P1, N=36, Active, not recruiting, Newave Pharmaceutical Inc | Recruiting --> Active, not recruiting

P2, N=90, Recruiting, Novartis Pharmaceuticals | Trial completion date: Mar 2025 --> Jun 2024 | Trial primary completion date: Jan 2024 --> Sep 2023

P2, N=77, Recruiting, The First Affiliated Hospital of Soochow University

The patient received 1 cycle of induction chemotherapy with azacytidine and achieved complete remission...CONCLUSIONS The mechanism of how normal donor hematopoietic cells transform to leukemia in the host remains unclear. Donor cell leukemia provides a unique opportunity to examine genetic variations in donors and hosts with regards to the progression to malignancy.

P1, N=27, Not yet recruiting, Shirley Ryan AbilityLab

P2, N=20, Recruiting, The First Affiliated Hospital of Soochow University | Not yet recruiting --> Recruiting | Initiation date: Oct 2023 --> Apr 2024

P1, N=24, Recruiting, St. Jude Children's Research Hospital | Not yet recruiting --> Recruiting

This study aimed to evaluate the impact of Spliceosome mutations in patients treated with Venetoclax and Azacitidine for newly diagnosed AML. This negative prognostic impact remained true in our multivariate analysis. We believe this finding should warrant further studies aimed at overcoming this negative impact.

P1/2, N=218, Active, not recruiting, ImmunoGen, Inc. | Recruiting --> Active, not recruiting | Phase classification: P1b/2 --> P1/2

P1/2, N=112, Not yet recruiting, Apollo Therapeutics Ltd

P2, N=196, Recruiting, Kirsten Grønbæk | Trial completion date: Sep 2027 --> Dec 2027 | Trial primary completion date: Sep 2024 --> Dec 2025

Finally, autophagy was associated with a lower abundance of CD8+ T-cell markers in AML patients expressing high levels of EREs. This work demonstrates that AZA-induced EREs are degraded by autophagy and shows that inhibiting autophagy can improve the immune recognition of AML blasts in treated patients.

P3, N=378, Terminated, Gilead Sciences | Trial completion date: Jul 2025 --> Apr 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2025 --> Apr 2024; Study was terminated due to futility

P=N/A, N=150, Recruiting, AbbVie | Trial completion date: Mar 2026 --> Nov 2026

P3, N=258, Terminated, Gilead Sciences | Active, not recruiting --> Terminated; Study discontinued due to futility.

Myelodysplastic syndromes (MDS) patients with DEAD-box helicase 41 (DDX41) mutations have been reported to be treated effectively with lenalidomide; however, there are no randomized studies to prove it. We retrospectively analyzed the genetic features and clinical characteristics of these patients. Our findings suggest that MDS patients with DDX41 mutation may benefit from the therapy, for six subjects received this regimen as initial therapy and five of the six subjects achieved complete remission.

EBER, DNA1, and DNA4 emerged as sensitive markers for prognosis. CHOP plus azacytidine might present a preferable option for PTCL patients with DNA methylation due to EBV infection.

P=N/A, N=70, Recruiting, AbbVie | Trial completion date: Dec 2025 --> Aug 2025 | Trial primary completion date: Dec 2025 --> Aug 2025

P1/2, N=0, Withdrawn, Novartis Pharmaceuticals | N=63 --> 0 | Not yet recruiting --> Withdrawn

P1, N=24, Not yet recruiting, OHSU Knight Cancer Institute

P2/3, N=116, Recruiting, The First Affiliated Hospital of Soochow University | Trial completion date: Jul 2027 --> Oct 2027 | Initiation date: Jul 2023 --> Apr 2024 | Trial primary completion date: Jul 2025 --> Oct 2025