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NCT05455294
Combination Navitoclax, Venetoclax and Decitabine for Advanced Myeloid Neoplasms
Phase 1 trial testing Navitoclax in Myeloid Malignancy in 16 participants. Participants enrolled and being followed up; not accepting new ones.
17 April 2024
Quick facts
| Lead sponsor | Jacqueline Garcia, MD |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 18 July 2022 |
| Primary completion | 17 April 2024 |
| Estimated completion | 31 December 2026 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Navitoclax — full drug profile →
- Venetoclax (venetoclax) — full drug profile →
- Decitabine (decitabine) — full drug profile →
Conditions studied
- Myeloid Malignancy — all drugs for Myeloid Malignancy →
- Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →
- Myelofibrosis — all drugs for Myelofibrosis →
- Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
Sponsor
Jacqueline Garcia, MD — full company profile →
Who can join
18 and older, any sex, with Myeloid Malignancy or Myelodysplastic Syndromes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this research study is to test the safety of a new three drug combination of navitoclax, decitabine, and venetoclax to treat advanced myeloid malignancies. The names of the drugs involved in this study are: * Venetoclax * Decitabine * Navitoclax
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting senescence as an anticancer therapy.
Bousset L, Gil J. · · 2022 · cited 70× · PMID 36065138 · DOI 10.1002/1878-0261.13312 -
Targeting epigenetic regulators as a promising avenue to overcome cancer therapy resistance.
Song J, Yang P, Chen C, Ding W, et al · · 2025 · cited 40× · PMID 40675967 · DOI 10.1038/s41392-025-02266-z -
Programmed cell death: molecular mechanisms, biological functions, diseases, and therapeutic targets.
Qian S, Long Y, Tan G, Li X, et al · · 2024 · cited 24× · PMID 39619229 · DOI 10.1002/mco2.70024 -
The NF-κB Pharmacopeia: Novel Strategies to Subdue an Intractable Target.
Verzella D, Cornice J, Arboretto P, Vecchiotti D, et al · · 2022 · cited 23× · PMID 36140335 · DOI 10.3390/biomedicines10092233 -
Emerging drugs targeting cellular redox homeostasis to eliminate acute myeloid leukemia stem cells.
Costa RGA, Silva SLR, Dias IRSB, Oliveira MS, et al · · 2023 · cited 16× · PMID 37031536 · DOI 10.1016/j.redox.2023.102692 -
The Interplay between Autophagy and Mitochondria in Cancer.
Zdanowicz A, Grosicka-Maciąg E. · · 2024 · cited 9× · PMID 39273093 · DOI 10.3390/ijms25179143 -
Impact of p53-associated acute myeloid leukemia hallmarks on metabolism and the immune environment.
Chomczyk M, Gazzola L, Dash S, Firmanty P, et al · · 2024 · cited 6× · PMID 39161899 · DOI 10.3389/fphar.2024.1409210 -
Novel therapies upon failure of HMA plus venetoclax.
Chan O, Walker AR. · · 2023 · cited 3× · PMID 38066883 · DOI 10.1182/hematology.2023000456
Verify or expand the search:
- PubMed search for NCT05455294
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Navitoclax
Trials testing the same drug.
- NCT06210750 — Adding Targeted Drugs to Usual Chemotherapy for Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) · Phase 2 · withdrawn
- NCT05740449 — HEM-iSMART-A: Decitabine / Venetoclax and Navitoclax in Pediatric Patients With Relapsed or Refractory Hematological Mal · Phase 1, PHASE2 · withdrawn
- NCT05864742 — Genetically Risk-Stratified Venetoclax, Ibrutinib, Rituximab (± Navitoclax) in Relapsed/Refractory Mantle Cell Lymphoma · Phase 2 · active not recruiting
- NCT05564650 — Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome · Phase 1 · active not recruiting
- NCT05358639 — Combination of Olaparib and Navitoclax in Women with HGSC and TNBC · Phase 1 · active not recruiting
Other recruiting trials for Myeloid Malignancy
Currently open trials in the same condition.
- NCT07263074 — Considering alloHCT: Opportunities for Patient Reflection During Decision-Making Via Digital Stories · NA · recruiting
- NCT06594445 — HM2023-05: GTB-3650 Trike for High Risk MDS and R/R AML · Phase 1 · recruiting
- NCT06621212 — Mitoxantrone Hydrochloride Liposome, Standard-dose of Cytarabine and Venetoclax in the Treatment of R/R AML · Phase 2 · recruiting
- NCT06378437 — A Study of GLB-001 in Patients With Myeloid Malignancies · Phase 1 · recruiting
- NCT05875805 — A Telehealth Advance Care Planning Intervention · NA · recruiting
Other Jacqueline Garcia, MD trials
Trials by the same sponsor.
- NCT07148180 — A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: · Phase 1, PHASE2 · recruiting
- NCT03613532 — Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN · Phase 1 · active not recruiting
- NCT03125239 — Combination Merestinib and LY2874455 for Patients With Relapsed or Refractory Acute Myeloid Leukemia · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05455294 (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 Jacqueline Garcia, MD
- Last refreshed: 28 January 2026
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/NCT05455294.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing