Acute Myeloid LeukemiaPhase 4NCT02926586
Fludarabine and Cytarabine Versus High-dose Cytarabine for CBF-AML
A Phase 4 study testing Fludarabine and Cytarabine in people with Acute Myeloid Leukemia and Core-Binding Factor, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Myeloid Leukemia, Core-Binding Factor
- What is being tested?
- Fludarabine and Cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to Jul 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Relapsed/refractory AML
- Serious liver/ kidney dysfunction
- Cardiac function level: 2 above
- Female in pregnancy or lactation
- With serious infection diseases or other diseases
- Not obey the principle of clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fludarabine and Cytarabine Versus High-dose Cytarabine in Consolidation Treatment of Core-bing Factor Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Study
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
Read the detailed description
The recurrence rate, relapse-free survival rate, and overall survival rate of CBF-AML patients were compared between FA and HIDAC regimens. Observe the prognostic value of factors such as c-KIT gene mutation and minimal residual disease (MRD).
- Conditions
- Acute Myeloid Leukemia, Core-Binding Factor
- Being tested
- Fludarabine, Cytarabine
- Keywords
- RUNX1-RUNX1T1, CBFβ-MYH11, fludarabine, cytarabine
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Also called Fludara
Fludarabine 50 mg/m2, IV (in the vein) in combination with cytarabine 1500mg/m2/d for 5 days with each cycle of 28 days. Number of cycles: 4
CytarabineDrug
Also called Cytosar
2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4
| Study group | Role | What they receive |
|---|---|---|
| Fludarabine | Experimental | The patients in experimental arm should receive the consolidation chemotherapy regimen with fludarabine and cytarabine. The dosage of fludarabine is 30mg/m2/d for 5 days intravenously and cytarabine is 1500mg/m2/d for 5 days intravenously. Receives: Drug: Fludarabine |
| high-dose cytarabine | Active comparator | The patients in control arm should receive the consolidation chemotherapy regimen with high-dose cytarabine. The dosage of cytarabine is 2000mg/m2/12h for 3 days (1,3,5) intravenously. Receives: Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with disease recurrence
Comparing the percentage of participants with disease recurrence with two therapeutic regimen
Measured: one year
Secondary outcomes (1)
Percentage of Participants in survival
Comparing the percentage of Participants in survival with two therapeutic regimen
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start1 Jan 2017
- Primary completion16 Aug 2020
- Study completionJul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xianmin Song, Doctor, Principal investigator, Department of hematology, Shanghai General Hospital, No. 100 Haining Road, Shang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926586
- Sponsor's protocol ID
- CBF-AML-2016
- Status last verified
- Sep 2024
- First submitted
- 5 Oct 2016
- Last updated
- 1 Oct 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fludarabine and Cytarabine Versus High-dose Cytarabine in Consolidation Treatment of Core-bing Factor Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Study
- ClinicalTrials.gov ID
- NCT02926586
- Acronym / sponsor ID
- CBF-AML-2016
- Conditions
- Acute Myeloid Leukemia, Core-Binding Factor
- Keywords
- RUNX1-RUNX1T1, CBFβ-MYH11, fludarabine, cytarabine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 16 Aug 2020 (actual)
- Study completion
- Jul 2024 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The recurrence rate, relapse-free survival rate, and overall survival rate of CBF-AML patients were compared between FA and HIDAC regimens. Observe the prognostic value of factors such as c-KIT gene mutation and minimal residual disease (MRD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fludarabine | Experimental | Drug: FludarabineThe patients in experimental arm should receive the consolidation chemotherapy regimen with fludarabine and cytarabine. The dosage of fludarabine is 30mg/m2/d for 5 days intravenously and cytarabine is 1500mg/m2/d for 5 days intravenously. |
| high-dose cytarabine | Active comparator | Drug: CytarabineThe patients in control arm should receive the consolidation chemotherapy regimen with high-dose cytarabine. The dosage of cytarabine is 2000mg/m2/12h for 3 days (1,3,5) intravenously. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Relapsed/refractory AML
- Serious liver/ kidney dysfunction
- Cardiac function level: 2 above
- Female in pregnancy or lactation
- With serious infection diseases or other diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FludarabineAlso: FludaraFludarabine 50 mg/m2, IV (in the vein) in combination with cytarabine 1500mg/m2/d for 5 days with each cycle of 28 days. Number of cycles: 4 | Drug | Fludarabine |
| CytarabineAlso: Cytosar2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4 | Drug | high-dose cytarabine |
Primary outcome
Percentage of participants with disease recurrence
Time frame: one year
Comparing the percentage of participants with disease recurrence with two therapeutic regimen
1 secondary outcome
Percentage of Participants in survival
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xianmin Song, Doctor principal investigator
Department of hematology, Shanghai General Hospital, No. 100 Haining Road, Shang
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fludarabine and Cytarabine in people with Acute Myeloid Leukemia and Core-Binding Factor, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with disease recurrence (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.