Myelodysplastic SyndromesNCT02328950
A 5 Day Course of Fludarabine and Cytarabine Followed by Full Intensity Allogeneic Stem Cell Transplantation (FA5-Bucy) in Treating Patients With High-risk, Recurrent or Refractory Acute Leukemia and Advanced Myelodysplastic Syndrome
An observational study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, run by Fujian Medical University at 1 site in China.
Trial summary
A 5 day course of fludarabine and cytarabine (FA) will be administered followed by full intensity conditioning regimen (Bucy) in the setting of allogeneic stem cell transplantation (SCT). Read more about this study
- Who is it for?
- Ages 1 year to 65 years
- Conditions the study is for
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma
- What is being tested?
- Fludarabine and Cytarabine followed by IV busulfan and cyclophosphamide
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Dec 2017
- Phase
- Observational
- 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 1 year to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with high-risk, recurrent or refractory acute leukemia and advanced myelodysplastic syndrome
Who may be able to join
- Signed written informed consent
- Aged between 0-65 years
- Patients suffering from either refractory de novo AML/ALL or relapsed AML/ALL or patients with very high risk AML/ALL in CR1
- Patients with advanced MDS
- Cardiac: Left ventricular ejection fraction ≥ 50%
- Adequate renal and hepatic function
- Performance status: Karnofsky ≥ 70%
Who cannot join
- Pregnant or lactating females
- Current participation in another clinical trial
- Contra-indication to one of the drug of the regimen
- Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital,Fujian Medical University
Fuzhou, Fujian, 350001
Ting Yang, Prof., +86-591-83357896 ext. 8041, yang.hopeting@gmail.com
Jianda Hu, Prof., +86-591-83357896 ext. 8041, jdhu@medmail.com.cn
About this study
A 5 day course of fludarabine and cytarabine (FA) will be administered followed by full intensity conditioning regimen (Bucy) in the setting of allogeneic stem cell transplantation (SCT). The purpose of this study is to explore the antileukemic, immunosuppressive effects and safety of FA as the backbone of a conditioning regiment for the treatment of patients with high-risk, recurrent or refractory acute Leukemia and advanced myelodysplastic syndrome.
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Being tested
- Fludarabine and Cytarabine followed by IV busulfan and cyclophosphamide
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludarabine and Cytarabine followed by IV busulfan and cyclophosphamideDrug
Fludarabine (F) 30 mg/m²/day for 5 days (day -12 to day-8) Cytarabine (A) 2g/m²/day for 5 days (day -12 to day-8) Bulsufan (Bu) 0.8mg/kg/day for 3 days (day -7 to day-5) Cyclophosphamide(Cy) 1.8g/m²/day for 3 days (day -4 to day-3)
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse rate at one year after allo-SCT
Measured: one year
Secondary outcomes (1)
Even free survival
- Overall Survival
- Leukemia Free Survival
- Graft Versus Host Disease
- Regimen related toxicity
Measured: two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionSep 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting YANG, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328950
- Sponsor's protocol ID
- FA5Bucy-SCT-01
- Status last verified
- Feb 2016
- First submitted
- 28 Dec 2014
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 5 Day Course of Fludarabine and Cytarabine Followed by Full Intensity Allogeneic Stem Cell Transplantation (FA5-Bucy) in Treating Patients With High-risk, Recurrent or Refractory Acute Leukemia and Advanced Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT02328950
- Acronym / sponsor ID
- FA5Bucy-SCT-01
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 31 Dec 2014 (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.
A 5 day course of fludarabine and cytarabine (FA) will be administered followed by full intensity conditioning regimen (Bucy) in the setting of allogeneic stem cell transplantation (SCT). The purpose of this study is to explore the antileukemic, immunosuppressive effects and safety of FA as the backbone of a conditioning regiment for the treatment of patients with high-risk, recurrent or refractory acute Leukemia and advanced myelodysplastic syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with high-risk, recurrent or refractory acute leukemia and advanced myelodysplastic syndrome
Key inclusion criteria (7 listed)
- Signed written informed consent
- Aged between 0-65 years
- Patients suffering from either refractory de novo AML/ALL or relapsed AML/ALL or patients with very high risk AML/ALL in CR1
- Patients with advanced MDS
- Cardiac: Left ventricular ejection fraction ≥ 50%
Key exclusion criteria (4 listed)
- Pregnant or lactating females
- Current participation in another clinical trial
- Contra-indication to one of the drug of the regimen
- Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen
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 |
|---|---|---|
| Fludarabine and Cytarabine followed by IV busulfan and cyclophosphamideFludarabine (F) 30 mg/m²/day for 5 days (day -12 to day-8) Cytarabine (A) 2g/m²/day for 5 days (day -12 to day-8) Bulsufan (Bu) 0.8mg/kg/day for 3 days (day -7 to day-5) Cyclophosphamide(Cy) 1.8g/m²/day for 3 days (day -4 to day-3) | Drug | – |
Primary outcome
Relapse rate at one year after allo-SCT
Time frame: one year
1 secondary outcome
Even free survival
Time frame: two year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, run by Fujian Medical University 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Feb 2016. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Yang, Prof. (+86-591-83357896 ext. 8041, yang.hopeting@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse rate at one year after allo-SCT (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 17 Feb 2016.