Lymphoma, Non-HodgkinPhase 2NCT02836639
BEB Conditioning Regimen for Autologous Stem-cell Transplantation(ASCT) in Non-Hodgkin's Lymphoma
A Phase 2 study testing Busulfan, Etoposide and Bendamustine in people with Lymphoma, Non-Hodgkin, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
Phase II study for safety and efficacy of BEB (Bendamustine, Etoposide, Busulfan) conditioning regimen for ASCT in non-Hodgkin's lymphoma Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- Busulfan, Etoposide and Bendamustine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2016to Dec 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically diagnosed non-Hodgkin's lymphoma
- 16 ≤ Age ≤ 65 years
- Adequate cardiac function with cardiac ejection fraction greater than 50% by echocardiogram or multiple gated acquisition scan(MUGA)
- Adequate kidney function with serum creatinine< 2.0 mg/dL
- Adequate liver function with /serum bilirubin lower than 2 times the normal upper limit, Aspartate aminotransferase(AST)/ Alanine aminotransaminase(ALT) lower than 3 times the normal upper limit. In case of DLBCL liver invasion; serum bilirubin lower than 5 times the normal upper limit, AST/ALT lower than 5 times the normal upper limit.
- Adequate bone marrow function with absolute neutrophil count ≥ 1,500/µL; platelets ≥ 75,000/µL; hemoglobin ≥ 9.0 g/dL
- Patients who voluntarily gave informed consent before performing any test that is not part of routine care of patients
- Candidate for ASCT
Who cannot join
- Positive serology for HIV, hepatitis C virus(HCV) If the hepatitis B virus(HBV) patient was administrated prophylactic antiviral agents. It would be eligible following the judgment of the investigator
- Pregnant or breast-feeding. Females of childbearing potential who do not agree to undergo pregnancy tests or repeated use effective birth control while included in the clinical trial.
- Patients with serious or uncontrolled medical condition; 1) Abnormalities in cardiac function or clinically significant heart disease such as congestive heart failure, arrhythmia, unstable angina with treatment within 6 months or acute myocardial infarction; 2) Previous history of serious neurological or psychiatric disease; 3) Acute, severe active infection requiring immediate treatment(Virus, Bacteria, Fungal infection); 4) chronic obstructive pulmonary disease requiring oral steroid therapy or Forced expiratory volume 1 sec(FEV1)<0.8 L less than the test of pulmonary function at rest; 5) If there are other diseases that are deemed inappropriate as a target of the present clinical trial following the Investigator's judgment; 6) Congenital or acquired bleeding disorders
- Patients receiving any other investigational systemic therapy (Hormone, Immune, chemotherapy)
- Allergic to the investigational drug
- Patients who have difficulty understanding the informed consent form or patients who did not give consent
Show all 9Show fewer
- Serum bilirubin upper than 2 times the normal upper limit
- Major surgery procedure within 30 days prior to start of investigational treatment
- Patients vaccinated against yellow fever
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Pusan National University Hospital
Busan
Hojin Shin, hojinja@hanmail.net
About this study
Official title: Phase II Study for Safety and Efficacy of BEB (Bendamustine, Etoposide, Busulfan) Conditioning Regimen for ASCT in Non-Hodgkin's Lymphoma
Phase II study for safety and efficacy of BEB (Bendamustine, Etoposide, Busulfan) conditioning regimen for ASCT in non-Hodgkin's lymphoma
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- Busulfan, Etoposide, Bendamustine
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BusulfanDrug
Busulfan 0.8 mg/kg four times per day from day -7 to day -5
EtoposideDrug
Etoposide 400 mg/m2 from day -5 to day -4
BendamustineDrug
Bendamustine 200 mg/m2 starting dose on day -3 and -2
| Study group | Role | What they receive |
|---|---|---|
| Busulfan, Etoposide, Bendamustine | Experimental | All patients will receive the conditioning regimen followed by autologous stem cell transplantation. Receives: Drug: Busulfan; Drug: Etoposide; Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 1 year after ASCT
Progression-free survival
Measured: 3 years after ASCT
Secondary outcomes (3)
Overall survival
Measured: 1 year and 3 year after ASCT
Complete response rate
Measured: 1 year and 3 year after ASCT
Incidence of adverse events
Measured: 1 year and 3 year after ASCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Non-HodgkinStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho-Jin Shin, Pusan National University Hospital
- Investigators
- Hojin Shin, Principal investigator, Pusan National Universty Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836639
- Sponsor's protocol ID
- BEB
- Status last verified
- Jul 2016
- First submitted
- 27 Jun 2016
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Visani G, Malerba L, Stefani PM, Capria S, Galieni P, Gaudio F, Specchia G, Meloni G, Gherlinzoni F, Giardini C, Falcioni S, Cuberli F, Gobbi M, Sarina B, Santoro A, Ferrara F, Rocchi M, Ocio EM, Caballero MD, Isidori A. BeEAM (bendamustine, etoposide, cytarabine, melphalan) before autologous stem cell transplantation is safe and effective for resistant/relapsed lymphoma patients. Blood. 2011 Sep 22;118(12):3419-25. doi: 10.1182/blood-2011-04-351924. Epub 2011 Aug 3.
PubMed 21816830Shin HJ, Lee WS, Lee HS, Kim H, Lee GW, Song MK, Kim JS, Yhim HY, Chung JS. Busulfan-containing conditioning regimens are optimal preparative regimens for autologous stem cell transplant in patients with diffuse large B-cell lymphoma. Leuk Lymphoma. 2014 Nov;55(11):2490-6. doi: 10.3109/10428194.2014.882504. Epub 2014 Mar 7.
PubMed 24432893
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study for Safety and Efficacy of BEB (Bendamustine, Etoposide, Busulfan) Conditioning Regimen for ASCT in Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT02836639
- Acronym / sponsor ID
- BEB
- Conditions
- Lymphoma, Non-Hodgkin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2019 (estimated)
- First posted
- 19 Jul 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.
Phase II study for safety and efficacy of BEB (Bendamustine, Etoposide, Busulfan) conditioning regimen for ASCT in non-Hodgkin's lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Busulfan, Etoposide, Bendamustine | Experimental | Drug: Busulfan, Drug: Etoposide, Drug: BendamustineAll patients will receive the conditioning regimen followed by autologous stem cell transplantation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with histologically diagnosed non-Hodgkin's lymphoma
- 16 ≤ Age ≤ 65 years
- Adequate cardiac function with cardiac ejection fraction greater than 50% by echocardiogram or multiple gated acquisition scan(MUGA)
- Adequate kidney function with serum creatinine< 2.0 mg/dL
- Adequate liver function with /serum bilirubin lower than 2 times the normal upper limit, Aspartate aminotransferase(AST)/ Alanine aminotransaminase(ALT) lower than 3 times the normal upper limit. In case of DLBCL liver invasion; serum bilirubin lower than 5 times the normal upper limit, AST/ALT lower than 5 times the normal upper limit.
Key exclusion criteria (9 listed)
- Positive serology for HIV, hepatitis C virus(HCV) If the hepatitis B virus(HBV) patient was administrated prophylactic antiviral agents. It would be eligible following the judgment of the investigator
- Pregnant or breast-feeding. Females of childbearing potential who do not agree to undergo pregnancy tests or repeated use effective birth control while included in the clinical trial.
- Patients with serious or uncontrolled medical condition; 1) Abnormalities in cardiac function or clinically significant heart disease such as congestive heart failure, arrhythmia, unstable angina with treatment within 6 months or acute myocardial infarction; 2) Previous history of serious neurological or psychiatric disease; 3) Acute, severe active infection requiring immediate treatment(Virus, Bacteria, Fungal infection); 4) chronic obstructive pulmonary disease requiring oral steroid therapy or Forced expiratory volume 1 sec(FEV1)<0.8 L less than the test of pulmonary function at rest; 5) If there are other diseases that are deemed inappropriate as a target of the present clinical trial following the Investigator's judgment; 6) Congenital or acquired bleeding disorders
- Patients receiving any other investigational systemic therapy (Hormone, Immune, chemotherapy)
- Allergic to the investigational drug
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 |
|---|---|---|
| BusulfanBusulfan 0.8 mg/kg four times per day from day -7 to day -5 | Drug | Busulfan, Etoposide, Bendamustine |
| EtoposideEtoposide 400 mg/m2 from day -5 to day -4 | Drug | Busulfan, Etoposide, Bendamustine |
| BendamustineBendamustine 200 mg/m2 starting dose on day -3 and -2 | Drug | Busulfan, Etoposide, Bendamustine |
Primary outcome
Progression-free survival
Time frame: 1 year after ASCT
Progression-free survival
Time frame: 3 years after ASCT
3 secondary outcomes
Overall survival
Time frame: 1 year and 3 year after ASCT
Complete response rate
Time frame: 1 year and 3 year after ASCT
Incidence of adverse events
Time frame: 1 year and 3 year after ASCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
- Background: PubMed 21816830Visani G, Malerba L, Stefani PM, Capria S, Galieni P, Gaudio F, Specchia G, Meloni G, Gherlinzoni F, Giardini C, Falcioni S, Cuberli F, Gobbi M, Sarina B, Santoro A, Ferrara F, Rocchi M, Ocio EM, Caballero MD, Isidori A. BeEAM (bendamustine, etoposide, cytarabine, melphalan) before autologous stem cell transplantation is safe and effective for resistant/relapsed lymphoma patients. Blood. 2011 Sep 22;118(12):3419-25. doi: 10.1182/blood-2011-04-351924. Epub 2011 Aug 3.
- Background: PubMed 24432893Shin HJ, Lee WS, Lee HS, Kim H, Lee GW, Song MK, Kim JS, Yhim HY, Chung JS. Busulfan-containing conditioning regimens are optimal preparative regimens for autologous stem cell transplant in patients with diffuse large B-cell lymphoma. Leuk Lymphoma. 2014 Nov;55(11):2490-6. doi: 10.3109/10428194.2014.882504. Epub 2014 Mar 7.
- Individual participant dataSharing planned: No
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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.
Hojin Shin principal investigator
Pusan National Universty 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 Busulfan, Etoposide and Bendamustine in people with Lymphoma, Non-Hodgkin, run by Pusan National University Hospital at 1 site in South Korea.
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 8 inclusion and 9 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 19 Jul 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 South Korea. 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 Jieon Lee (+82-51-240-7053, jieon@pnuh.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 1 year after ASCT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02836639, which also lists 2 linked publications.
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 19 Jul 2016.