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NCT04914676
Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML) in Complete Remission
Phase 2 trial testing Cytarabine in Acute Myeloid Leukemia in 5 participants. Terminated before completion.
12 January 2024
Quick facts
| Lead sponsor | University of Florida |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 5 |
| Start date | 8 March 2022 |
| Primary completion | 12 January 2024 |
| Estimated completion | 26 August 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Cytarabine — full drug profile →
- Cytarabine — full drug profile →
Conditions studied
- Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
Sponsor
University of Florida
Who can join
Adults 61 to 99, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from the time of informed consent until 28 days after the last dose of study treatment or the start of a new chemotherapy regimen (whichever came first). Adverse event data were collected for a maximum of 165 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (6 terms)
| Reaction | System | Prospective HiDAC Treatmen… | Historical HiDAC Treatment… |
|---|---|---|---|
| Altered mental status | Nervous system disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Lung infection | Infections and infestations | — | — |
| Platelet count decreased | Investigations | — | — |
| Meningoencephalitis | Infections and infestations | — | — |
| Sepsis | Infections and infestations | — | — |
Other adverse events (8 terms — click to expand)
| Reaction | System | Prospective HiDAC Treatmen… | Historical HiDAC Treatment… |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Platelet count decreased | Investigations | — | — |
| White blood cell decreased | Investigations | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Absolute neutrophil count decreased | Investigations | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Altered mental status | Nervous system disorders | — | — |
Most-reported serious reactions: Altered mental status, Anemia, Lung infection, Platelet count decreased, Meningoencephalitis, Sepsis.
Data from ClinicalTrials.gov NCT04914676 adverse events section.
Sponsor's own description
This phase 2, open label, non-randomized study will evaluate the safety of administering high dose cytarabine (HiDAC) consolidation therapy on days 1-3 of each cycle, as compared to standard administration on days 1, 3, and 5 of each cycle, in patients 61 years and older with de novo acute myeloid leukemia (AML).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04914676
- Europe PMC full search
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- ESMO Meeting Library
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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 NCT04914676 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Florida
- Last refreshed: 16 January 2025
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/NCT04914676.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing