Non-Hodgkin's LymphomaPhase 2NCT00336843
Zevalin Plus BuCyE High-dose Therapy in B-cell Non-Hodgkin's Lymphoma
A Phase 2 study testing Zevalin-BuCyE in people with Non-Hodgkin's Lymphoma, run by Asan Medical Center at 1 site in South Korea.
Trial summary
In order to improve the clinical result of high-dose chemotherapy and autologous stem cell transplantation for B-cell non-Hodgkin's lymphoma, Zevalin will be added to the conditioning regimen. Read more about this study
- Who is it for?
- Ages Up to 64 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Zevalin-BuCyE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2005to May 2010
- 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 Up to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Histologically confirmed B-cell NHL in chemotherapy-sensitive relapse, in partial response to 1st line chemotherapy, or in complete response after 1st line chemotherapy with high IPI score at diagnosis
- Age < 65 years old
- WHO performance status (PS) of 0-2
- ANC > 1,500/mm3, platelet > 100,000/mm3
- Cr < 2.0 mg% or Ccr > 50 mL/min
- Transaminase < 3X upper normal value
Show all 10Show fewer
- Bilirubin < 2 mg/dL
- Life expectancy of at least 3 months
- Written informed consent
- Optimal harvest of autologous stem cells (CD34+ cells > 5 million/kg plus 2 million/kg for back-up)
Who cannot join
- Prior hematopoietic stem cell transplantation
- Prior RIT
- Prior external radiation to > 25% of active bone marrow
- CNS involvement of non-Hodgkin's lymphoma
- Serious comorbid diseases
- HIV or HTLV-1 associated malignancy
Show all 12Show fewer
- History of other malignant disease in the previous 5 years, except squamous cell or basal cell carcinoma of skin or stage I uterine cervical carcinoma or cervical carcinoma in situ
- Known hypersensitivity to murine antibodies/proteins
- Pregnant or breast feeding female patients, adults without effective contraception up to 12 months after RIT
- Persistent toxic side effects from prior therapy
- Prior biologic or immunotherapy less than 4 weeks prior to entry on this study
- Investigational drugs less than 4 weeks prior to entry on this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center, Departement of Internal Medicine, Division of Oncology
Seoul, 138-736
About this study
Official title: Combining 90Y-ibritumomab Tiuxetan With High-dose Chemotherapy of BuCyE and Autologous Stem Cell Transplantation in Patients With B-cell Non-Hodgkin's Lymphoma - an Open-labeled Phase II Study
In order to improve the clinical result of high-dose chemotherapy and autologous stem cell transplantation for B-cell non-Hodgkin's lymphoma, Zevalin will be added to the conditioning regimen. Investigators expect this radioimmunotherapy of Zevalin plus busulfan, cyclophosphamide and etoposide regimen will improve survival of relapsed or poor-risk B-cell non-Hodgkin's lymphoma.
Read the detailed description
Title: Combining 90Y-Ibritumomab tiuxetan (Zevalin) with high-dose chemotherapy of BuCyE and autologous stem cell transplantation in patients with relapsed, refractory, or high-risk B-cell non-Hodgkin's lymphoma - an open-labeled phase II study.
Study design: Prospective, multicenter, open-labeled, phase II trial.
Study objectives:
- Primary: event-free survival time following autologous stem cell transplantation with 90Y-Ibritumomab tiuxetan and BuCyE high-dose chemotherapy in patients with relapsed, refractory, or high-risk B-cell non-Hodgkin's lymphoma
- Secondary: overall survival response rate toxicity of the treatment combination
Treatment:
Z-BuCyE Regimen
- Day 21: rituximab, 250 mg/m2, I.V.
- Day 14: rituximab, 250 mg/m2, I.V. 90Y-Ibritumomab tiuxetan, 0.4 mCi/kg, I.V.
- Day 7, 6, 5: busulfan 3.2 mg/kg I.V.
- Day 5, 4: etoposide 200 mg/m2 I.V. every 12 hours
- Day 3, 2: Cytoxan 50 mg/kg I.V.
- Day 0: autologous stem cell infusion
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Zevalin-BuCyE
- Keywords
- Zevalin, B-cell non-Hodgkin's lymphoma, autologous stem cell transplantation, BuCyE regimen
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zevalin-BuCyEDrug
rituximab (IV, 250 mg/m2 on days -21 and -14) single dose of 90Y-ibritumomab (IV, 0.4 mCi/kg on day -14) Busulfan (IV, 0.8 mg/kg every 6 h from day -7 to day -5) Cyclophosphamide (IV, 50 mg/kg on days -3 and -2) Etoposide (IV, 200 mg/m2 every 12 h on days -5 and -4) Autologous stem cells infusion on day 0
| Study group | Role | What they receive |
|---|---|---|
| Zevalin-BuCyE | Experimental | histologically confirmed, relapsed or refractory CD20 positive B-cell NHL including diffuse large B-cell, follicular, mantle cell, and Burkitt lymphomas. Receives: Drug: Zevalin-BuCyE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Three year event-free survival rate would be reported.
Measured: the time from stem cell infusion to failure or death from any cause
Secondary outcomes (2)
Overall survival
Three year overall survival would be reported.
Measured: from stem cell infusion to death of any cause or last follow-up
Toxicity of the treatment combination
Adverse events would be assessed and graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE), version 3.0. And the frequency of each grade would be reported as case number and proportion.
Measured: any toxicity due to study treatment during study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2006 (estimated)
- Study startNov 2005
- Primary completionFeb 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Responsible party
- Principal investigator, Cheolwon Suh, Asan Medical Center
- Investigators
- Cheolwon Suh, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336843
- Sponsor's protocol ID
- AMC 2005-276
- Status last verified
- Feb 2016
- First submitted
- 13 Jun 2006
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kang BW, Kim WS, Kim C, Jang G, Lee SS, Choi YH, Lee DH, Kim SW, Kim S, Ryu JS, Huh J, Lee JS, Suh C. Yttrium-90-ibritumomab tiuxetan in combination with intravenous busulfan, cyclophosphamide, and etoposide followed by autologous stem cell transplantation in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Invest New Drugs. 2010 Aug;28(4):516-22. doi: 10.1007/s10637-009-9283-z. Epub 2009 Jun 23.
PubMed 19547918
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
- Combining 90Y-ibritumomab Tiuxetan With High-dose Chemotherapy of BuCyE and Autologous Stem Cell Transplantation in Patients With B-cell Non-Hodgkin's Lymphoma - an Open-labeled Phase II Study
- ClinicalTrials.gov ID
- NCT00336843
- Acronym / sponsor ID
- AMC 2005-276
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- Zevalin, B-cell non-Hodgkin's lymphoma, autologous stem cell transplantation, BuCyE regimen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Nov 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 14 Jun 2006 (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.
In order to improve the clinical result of high-dose chemotherapy and autologous stem cell transplantation for B-cell non-Hodgkin's lymphoma, Zevalin will be added to the conditioning regimen. Investigators expect this radioimmunotherapy of Zevalin plus busulfan, cyclophosphamide and etoposide regimen will improve survival of relapsed or poor-risk B-cell non-Hodgkin's lymphoma.
Detailed description
Title: Combining 90Y-Ibritumomab tiuxetan (Zevalin) with high-dose chemotherapy of BuCyE and autologous stem cell transplantation in patients with relapsed, refractory, or high-risk B-cell non-Hodgkin's lymphoma - an open-labeled phase II study.
Study design: Prospective, multicenter, open-labeled, phase II trial.
Study objectives:
- Primary: event-free survival time following autologous stem cell transplantation with 90Y-Ibritumomab tiuxetan and BuCyE high-dose chemotherapy in patients with relapsed, refractory, or high-risk B-cell non-Hodgkin's lymphoma
- Secondary: overall survival response rate toxicity of the treatment combination
Treatment:
Z-BuCyE Regimen
- Day 21: rituximab, 250 mg/m2, I.V.
- Day 14: rituximab, 250 mg/m2, I.V. 90Y-Ibritumomab tiuxetan, 0.4 mCi/kg, I.V.
- Day 7, 6, 5: busulfan 3.2 mg/kg I.V.
- Day 5, 4: etoposide 200 mg/m2 I.V. every 12 hours
- Day 3, 2: Cytoxan 50 mg/kg I.V.
- Day 0: autologous stem cell infusion
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zevalin-BuCyE | Experimental | Drug: Zevalin-BuCyEhistologically confirmed, relapsed or refractory CD20 positive B-cell NHL including diffuse large B-cell, follicular, mantle cell, and Burkitt lymphomas. |
Who may qualify
- Ages
- Up to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Histologically confirmed B-cell NHL in chemotherapy-sensitive relapse, in partial response to 1st line chemotherapy, or in complete response after 1st line chemotherapy with high IPI score at diagnosis
- Age < 65 years old
- WHO performance status (PS) of 0-2
- ANC > 1,500/mm3, platelet > 100,000/mm3
- Cr < 2.0 mg% or Ccr > 50 mL/min
Key exclusion criteria (12 listed)
- Prior hematopoietic stem cell transplantation
- Prior RIT
- Prior external radiation to > 25% of active bone marrow
- CNS involvement of non-Hodgkin's lymphoma
- Serious comorbid 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 |
|---|---|---|
| Zevalin-BuCyErituximab (IV, 250 mg/m2 on days -21 and -14) single dose of 90Y-ibritumomab (IV, 0.4 mCi/kg on day -14) Busulfan (IV, 0.8 mg/kg every 6 h from day -7 to day -5) Cyclophosphamide (IV, 50 mg/kg on days -3 and -2) Etoposide (IV, 200 mg/m2 every 12 h on days -5 and -4) Autologous stem cells infusion on day 0 | Drug | Zevalin-BuCyE |
Primary outcome
Event-free survival
Time frame: the time from stem cell infusion to failure or death from any cause
Three year event-free survival rate would be reported.
2 secondary outcomes
Overall survival
Time frame: from stem cell infusion to death of any cause or last follow-up
Toxicity of the treatment combination
Time frame: any toxicity due to study treatment during study period
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 17 Feb 2016.
- Results publication: PubMed 19547918Kang BW, Kim WS, Kim C, Jang G, Lee SS, Choi YH, Lee DH, Kim SW, Kim S, Ryu JS, Huh J, Lee JS, Suh C. Yttrium-90-ibritumomab tiuxetan in combination with intravenous busulfan, cyclophosphamide, and etoposide followed by autologous stem cell transplantation in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Invest New Drugs. 2010 Aug;28(4):516-22. doi: 10.1007/s10637-009-9283-z. Epub 2009 Jun 23.
- Individual participant dataSharing planned: No
Related trials for Non-Hodgkin's Lymphoma
Active, not recruitingPhase 1
Pembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL.
Grade 3b Follicular Lymphoma, Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between DLBCL and Classic HL
Active, not recruitingObservational study
Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer
Waldenstrom Macroglobulinemia, Chronic Lymphocytic Leukemia
RecruitingPhase 1
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
B-cell Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma
Active, not recruitingPhase 1
A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R B-Cell NHL)
Lymphoma, Non-Hodgkin
Active, not recruitingPhase 3
A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
Non-Hodgkin Lymphoma
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.
Cheolwon Suh, MD, PhD principal investigator
Asan Medical Center
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 Zevalin-BuCyE in people with Non-Hodgkin's Lymphoma, run by Asan Medical Center 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 10 inclusion and 12 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 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 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?
Event-free survival (time frame: the time from stem cell infusion to failure or death from any cause). 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 NCT00336843, which also lists 1 linked publication.
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.