NCT02926586CompletedPhase 4
Fludarabine and Cytarabine Versus High-dose Cytarabine for CBF-AML
Fludarabine and Cytarabine Versus High-dose Cytarabine in Consolidation Treatment of Core-bing Factor Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Study
Source: ClinicalTrials.gov · Last updated 1 Oct 2024
Brief summary (registry, in English)
The purpose of the study is to determine whether Fludarabine in combination with cytarabine is more effective than high-dose cytarabine in post-remission therapy for patients with core-binding factor acute myeloid leukemia
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 68 (actual)
- First submitted
- 5 Oct 2016
- Start date
- 1 Jan 2017
- Primary completion date
- 16 Aug 2020
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT02926586
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 68
- From 1 Jan 2017 to the primary completion date, 16 Aug 2020
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cardiac function level: 2 above
- With serious infection diseases or other diseases
Other
- Relapsed/refractory AML
- Serious liver/ kidney dysfunction
- Female in pregnancy or lactation
- Not obey the principle of clinical study
Who the study is looking for
- Clinical and laboratory diagnosis of CBF-AML,including RUNX1-RUNX1T1 and CBF-MYH11 fusion gene rearrangement by PCR/FISH
- In status of complete remission after one to two courses of induction therapy
- Total bilirubinic acid ≤ 35μmol/L, AST/ALT\<2 times abnormal level, serum creatinine \< 1.5mg/ml
- Cardiac function: EF ≥ 50%
- Hydroxyurea can be used for patient with white blood cell count ≥ 50\*109/L
- ECOG (Eastern Cooperative Oncology Group) score: ≤ 2
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xianmin Song Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.