Lymphoid NeoplasmPhase 2NCT04897139
Flu-Bu-Mel Based Conditioning Regimen for Patients With Lymphoid Malignancies Undergoing Allo-HSCT
A Phase 2 study testing Flu-Bu-Mel-E in people with Lymphoid Neoplasm, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
In this phase II clinical trial, we evaluate the efficacy and feasibility of conditioning regimen of fludarabine 150mg/m2, busulfan 9.6mg/kg, melphalan 100mg/m2 and etoposide 800mg/m2 in patients with lymphoid malignancies. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Lymphoid Neoplasm
- What is being tested?
- Flu-Bu-Mel-E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Dec 2024
- Phase
- Phase 2
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- lymphoid malignancies
- donor available: HLA matched sibling, unrelated donor or haplo-identical related donor.
- patients with ECOG <3
Who cannot join
- inform consent not provided
- ECOG >=3
- poor liver function (enzyme >2N or bilirubin >2N)
- poor renal function (Scr >2N)
- poor cardiac function (EF <45%)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, 200025
Jiong HU, M.D., 86-21-64370045 ext. 601818, hj10709@rjh.com.cn
About this study
Official title: Phase II Clinical Trial of Flu-Bu-Mel-E (Fludarabine, Busulfan, Melphalan and Etoposide) as Conditioning Regimen for Patients With Lymphoid Malignancies Undergoing Allogeneic Stem Cell Transplantation
In this phase II clinical trial, we evaluate the efficacy and feasibility of conditioning regimen of fludarabine 150mg/m2, busulfan 9.6mg/kg, melphalan 100mg/m2 and etoposide 800mg/m2 in patients with lymphoid malignancies.
- Conditions
- Lymphoid Neoplasm
- Being tested
- Flu-Bu-Mel-E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flu-Bu-Mel-EDrug
Fludarabine 150mg/m2, busulfan 6.4mg/kg, melphalan 100mg/m2 and etoposide 600mg/m2
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | treatment arm Receives: Drug: Flu-Bu-Mel-E |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
event defined as disease progression, relapse or death of any causes
Measured: 1 year after allo-HSCT
Secondary outcomes (4)
Overall survival
event defined as death of any causes
Measured: 1 year after allo-HSCT
Non relapse morality
event defined as death of any causes except for disease progression or relapse
Measured: 1 year after allo-HSCT
Relapse
event defined as disease progression or relapse
Measured: 1 year after allo-HSCT
GVHD-free or relapse-free survival
event defined as disease progression or relapse, death of any cause, grade III-IV aGVHD or moderate to severe cGVHD
Measured: 1 year after allo-HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start1 Jan 2021
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoid NeoplasmStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiong HU, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jiong HU, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897139
- Sponsor's protocol ID
- RJH-Lym-2021
- Status last verified
- Oct 2023
- First submitted
- 19 May 2021
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Flu-Bu-Mel-E (Fludarabine, Busulfan, Melphalan and Etoposide) as Conditioning Regimen for Patients With Lymphoid Malignancies Undergoing Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04897139
- Acronym / sponsor ID
- RJH-Lym-2021
- Conditions
- Lymphoid Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 21 May 2021 (actual)
- 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.
In this phase II clinical trial, we evaluate the efficacy and feasibility of conditioning regimen of fludarabine 150mg/m2, busulfan 9.6mg/kg, melphalan 100mg/m2 and etoposide 800mg/m2 in patients with lymphoid malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: Flu-Bu-Mel-Etreatment arm |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- lymphoid malignancies
- donor available: HLA matched sibling, unrelated donor or haplo-identical related donor.
- patients with ECOG <3
Key exclusion criteria (5 listed)
- inform consent not provided
- ECOG >=3
- poor liver function (enzyme >2N or bilirubin >2N)
- poor renal function (Scr >2N)
- poor cardiac function (EF <45%)
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 |
|---|---|---|
| Flu-Bu-Mel-EFludarabine 150mg/m2, busulfan 6.4mg/kg, melphalan 100mg/m2 and etoposide 600mg/m2 | Drug | treatment arm |
Primary outcome
disease-free survival
Time frame: 1 year after allo-HSCT
event defined as disease progression, relapse or death of any causes
4 secondary outcomes
Overall survival
Time frame: 1 year after allo-HSCT
Non relapse morality
Time frame: 1 year after allo-HSCT
Relapse
Time frame: 1 year after allo-HSCT
GVHD-free or relapse-free survival
Time frame: 1 year after allo-HSCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
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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.
Jiong HU principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flu-Bu-Mel-E in people with Lymphoid Neoplasm, run by 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 3 inclusion and 5 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 25 Oct 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jiong Hu (86-21-64370045 ext. 601818, hj10709@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (time frame: 1 year after allo-HSCT). 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 25 Oct 2023.