Non-hodgkin LymphomaPhase 2CISLNCT03794167
BuCE Versus BuME as Conditioning Therapy in Non-Hodgkin's Lymphoma
A Phase 2 study testing Busulfan, Cyclophosphamide and Etoposide in people with Non-hodgkin Lymphoma, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
The investigators developed a protocol comparing busulfan/cyclophosphamide/etoposide (BuCE) and busulfan/melphalan/etoposide (BuME) regimen as a conditioning for high-dose therapy (HDT) in the patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-hodgkin Lymphoma
- What is being tested?
- Busulfan, Cyclophosphamide and Etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2012to 30 Nov 2018
- 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
- Histologically confirmed aggressive NHL
- Mantle cell lymphoma
- salvage chemotherapy sensitive relapse/refractory NHL or high risk NHL with remission in induction chemotherapy
- Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2.
- Age; 18-65
- Adequate renal function: serum creatinine ≤ 1.5mg/dL
- Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value \& Bilirubin < 2 X upper normal value
Who cannot join
- low grade NHL
- Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
- Other serious illness or medical conditions
- Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- History of significant neurological or psychiatric disorders
- Active uncontrolled infection (viral, bacterial or fungal infection)
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- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- HIV (+)
- Patients who have hepatitis B virus (HBV) (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase II Multi-center Trial of Busulfan, Etoposide, and Cyclophosphamide Versus Busulfan, Etoposide, and Melphalan as Conditioning Therapy for Autologous Stem-cell Transplantation(ASCT) in Patients With Non-Hodgkin's Lymphoma
The investigators developed a protocol comparing busulfan/cyclophosphamide/etoposide (BuCE) and busulfan/melphalan/etoposide (BuME) regimen as a conditioning for high-dose therapy (HDT) in the patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).
Read the detailed description
Intravenous busulfan containing regimens as conditioning regimen have been used for both allogeneic and autologous stem cell transplantation in patients with hematologic and non-hematologic malignancies.
The investigators have previously studied that conditioning regimen of i.v. busulfan/melphalan/etoposide (BuME) was well tolerated and effective in patients with relapsed or high risk NHL. And busulfan/cyclophosphamide/etoposide (BuCE) conditioning regimen has been extensively utilized in ASCT for NHL.
Therefore, based on the encouraging results, the investigators will conduct a randomized phase II multicenter trial of BuCE versus BuME as conditioning therapy for ASCT in patients with NHL.
- Conditions
- Non-hodgkin Lymphoma
- Being tested
- Busulfan, Cyclophosphamide, Etoposide, Melphalan
- 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
Also called Busulfex
busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6
CyclophosphamideDrug
cyclophosphamide 50mg/kg/day i.v. on days -3 and -2
EtoposideDrug
etoposide 400mg/m2 day i.v. on days -5 and -4
MelphalanDrug
Also called Alkeran
melphalan 50mg/m2/day i.v. on days -3 and -2
| Study group | Role | What they receive |
|---|---|---|
| busulfan cyclophosphamide etoposide | Experimental | busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6, cyclophosphamide 50mg/kg/day i.v. on days -3 and -2 etoposide 400mg/m2 day i.v. on days -5 and -4 Receives: Drug: Busulfan; Drug: Cyclophosphamide; Drug: Etoposide |
| busulfan melphalan etoposide | Active comparator | busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6 melphalan 50mg/m2/day i.v. on days -3 and -2 etoposide 400mg/m2 day i.v. on days -5 and -4 Receives: Drug: Busulfan; Drug: Etoposide; Drug: Melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of progression free survival
calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death Calculate from the date of ASCT (autologous stem cell transplantation) until the time of disease progression, relapse, or death
Measured: 2 years
Secondary outcomes (2)
Rate of overall survival
calculate from the date of ASCT until the time of death from any causes
Measured: 2 years
Rate of regimen related toxicity
calculate toxicities frequency
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start1 Jun 2012
- Primary completion30 May 2017
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-hodgkin LymphomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong-Ho Won, Soonchunhyang University Hospital
- Investigators
- Jong-Ho Won, Professor, Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794167
- Sponsor's protocol ID
- CISL 12-05
- Acronym
- CISL
- Status last verified
- Jan 2019
- First submitted
- 3 Jan 2019
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Multi-center Trial of Busulfan, Etoposide, and Cyclophosphamide Versus Busulfan, Etoposide, and Melphalan as Conditioning Therapy for Autologous Stem-cell Transplantation(ASCT) in Patients With Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT03794167
- Acronym / sponsor ID
- CISL / CISL 12-05
- Conditions
- Non-hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 4 Jan 2019 (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.
The investigators developed a protocol comparing busulfan/cyclophosphamide/etoposide (BuCE) and busulfan/melphalan/etoposide (BuME) regimen as a conditioning for high-dose therapy (HDT) in the patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).
Detailed description
Intravenous busulfan containing regimens as conditioning regimen have been used for both allogeneic and autologous stem cell transplantation in patients with hematologic and non-hematologic malignancies.
The investigators have previously studied that conditioning regimen of i.v. busulfan/melphalan/etoposide (BuME) was well tolerated and effective in patients with relapsed or high risk NHL. And busulfan/cyclophosphamide/etoposide (BuCE) conditioning regimen has been extensively utilized in ASCT for NHL.
Therefore, based on the encouraging results, the investigators will conduct a randomized phase II multicenter trial of BuCE versus BuME as conditioning therapy for ASCT in patients with NHL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| busulfan cyclophosphamide etoposide | Experimental | Drug: Busulfan, Drug: Cyclophosphamide, Drug: Etoposidebusulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6, cyclophosphamide 50mg/kg/day i.v. on days -3 and -2 etoposide 400mg/m2 day i.v. on days -5 and -4 |
| busulfan melphalan etoposide | Active comparator | Drug: Busulfan, Drug: Etoposide, Drug: Melphalanbusulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6 melphalan 50mg/m2/day i.v. on days -3 and -2 etoposide 400mg/m2 day i.v. on days -5 and -4 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed aggressive NHL
- Mantle cell lymphoma
- salvage chemotherapy sensitive relapse/refractory NHL or high risk NHL with remission in induction chemotherapy
- Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2.
- Age; 18-65
Key exclusion criteria (9 listed)
- low grade NHL
- Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
- Other serious illness or medical conditions
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- HIV (+)
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 |
|---|---|---|
| BusulfanAlso: Busulfexbusulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6 | Drug | busulfan cyclophosphamide etoposide, busulfan melphalan etoposide |
| Cyclophosphamidecyclophosphamide 50mg/kg/day i.v. on days -3 and -2 | Drug | busulfan cyclophosphamide etoposide |
| Etoposideetoposide 400mg/m2 day i.v. on days -5 and -4 | Drug | busulfan cyclophosphamide etoposide, busulfan melphalan etoposide |
| MelphalanAlso: Alkeranmelphalan 50mg/m2/day i.v. on days -3 and -2 | Drug | busulfan melphalan etoposide |
Primary outcome
Rate of progression free survival
Time frame: 2 years
calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death Calculate from the date of ASCT (autologous stem cell transplantation) until the time of disease progression, relapse, or death
2 secondary outcomes
Rate of overall survival
Time frame: 2 years
Rate of regimen related toxicity
Time frame: 6 months
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 7 Jan 2019.
- 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.
Jong-Ho Won, Professor principal investigator
Soonchunhyang University 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, Cyclophosphamide and Etoposide in people with Non-hodgkin Lymphoma, run by Soonchunhyang 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 7 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: finished, as of the sponsor's last update on 7 Jan 2019. 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?
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?
Rate of progression free survival (time frame: 2 years). 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 7 Jan 2019.