cytarabine

P3, N=1300, Recruiting, Kura Oncology, Inc.

P2, N=180, Not yet recruiting, The First Affiliated Hospital of Soochow University

P2, N=10, Terminated, University of Michigan Rogel Cancer Center | N=20 --> 10 | Trial completion date: Jul 2026 --> Aug 2025 | Suspended --> Terminated | Trial primary completion date: Jul 2026 --> Aug 2025; Interim Analysis per Protocol

P2, N=160, Recruiting, Chinese PLA General Hospital | Active, not recruiting --> Recruiting

The multi-national phase 1/2 SKIPPER study evaluated gilteritinib combined with fludarabine and cytarabine chemotherapy and granulocyte colony‑stimulating factor (FLAG) in children and adolescents/young adults with relapsed/refractory FLT3‑ITD AML. The gilteritinib and FLAG regimen had manageable safety, induced high remission rates, and enabled allogeneic hematopoietic stem cell transplant for several patients. Although limited by a small sample size, these findings support further evaluation of gilteritinib in pediatric patients with FLT3-mutated AML, particularly in frontline settings (ClinicalTrials.gov Identifier: NCT04240002).

P1, N=0, Withdrawn, M.D. Anderson Cancer Center | N=24 --> 0 | Trial completion date: Jun 2032 --> Apr 2026 | Initiation date: Aug 2026 --> Apr 2026 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jun 2030 --> Apr 2026

In younger, fit patients, first-line therapy traditionally involves dose-intensified chemoimmunotherapy with high-dose cytarabine and autologous stem-cell transplantation (ASCT). The incorporation of Bruton tyrosine kinase inhibitors (BTKi), such as ibrutinib, into induction regimens has improved survival outcomes, with emerging evidence that may limit the use of ASCT to high-risk subsets...In older or transplant-ineligible patients, bendamustine-rituximab remains a backbone therapy, with chemotherapy-free combinations incorporating BTKi, BCL2 inhibitors, and anti-CD20 antibodies offering effective, well-tolerated alternatives...Ongoing trials are evaluating optimal sequencing and combination strategies to improve outcomes, particularly in high-risk and cBTKi-exposed patients. Overall, modern MCL management emphasizes individualized therapy based on biological risk, functional status, and treatment tolerability, with novel targeted and cellular approaches reshaping the frontline and relapsed treatment landscape.

P3, N=683, Recruiting, University Hospital Muenster | Trial completion date: Nov 2027 --> Apr 2030 | Trial primary completion date: Nov 2027 --> Apr 2030

Collectively, these findings suggest that ASXL1MUT AML may be more appropriately classified as intermediate risk in the context of LIT+VEN-based therapy, with the depth of impact influenced by the specific LIT backbone.

P1, N=0, Withdrawn, Children's Oncology Group | N=29 --> 0 | Not yet recruiting --> Withdrawn

P3, N=276, Active, not recruiting, Astellas Pharma Inc | Trial completion date: Mar 2026 --> Mar 2027

P1, N=24, Recruiting, St. Jude Children's Research Hospital | Trial primary completion date: Jul 2026 --> Oct 2026