Lymphoma, Large Cell, DiffusePhase 2ZBEAM2NCT00689169
Targeted Intensification With ZBEAM and Autologous Stem Cell Transplantation in Patients With High-grade B-Cell Lymphoma
A Phase 2 study testing ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan), ASCT and Rituximab in people with Lymphoma, Large Cell, Diffuse, run by Lymphoma Study Association at 1 site in France.
Trial summary
The purpose of this study is to evaluate the efficacy and the safety of a preparative regimen utilizing standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy combined with high-dose BEAM followed by ASCT after first line treatment in patients aged from 18 to 65 years with poor prognosis CD 20… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphoma, Large Cell, Diffuse
- What is being tested?
- ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan), ASCT and Rituximab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2007to Jan 2014
- 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
- Aged from 18 to 65 years.
- Patient with pathologically proven, high grade B-cell Lymphoma CD 20 positive (WHO classification) :
- Diffuse large B cell lymphoma.
- Adverse prognostic factors IPI>1
- In Complete Remission, or partial response to first line treatment.
- Previously treated with chemotherapy regimen containing rituximab: R CHOP or R ACVBP
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- Chemo-sensitive disease
- PET Scan prior transplant
- Eligible for autologous stem cell transplantation
- With a minimum life expectancy of 3 months.
- Negative HIV, HBV and HCV serologies (in the last 4 weeks except after vaccination).
- Having previously signed a written informed consent.
Who cannot join
- Histological transformation in diffuse large B cell lymphoma, any type of low grade lymphoma
- More than one line of treatment. Prior transplantation. Prior exposure to Zevalin
- Central nervous system or meningeal involvement by lymphoma.
- Contraindication to any drug contained in the chemotherapy regimen.
- Any serious active disease or co-morbid medical condition (according to the investigator's decision and information provided in the IDB).
- Poor renal function (creatinin level up to 2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
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- Poor hepatic function (total bilirubin level up to 30 micro mol/l, transaminases up to 2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
- Poor bone marrow reserve as defined by neutrophils less than 1.5 G/l or platelets less than 100 G/l
- Large bone marrow irradiation more than 40percent.
- Bone marrow infiltration
- Lack of sufficient autologous hematopoietic stem cells for transplantation.
- Prior treatment with murine antibodies
- Known hypersensibility to murine antibodies or proteins
- Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
- Adult patient unable to give informed consent because of intellectual impairment.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
France1 site
service d'onco hématologie adultes, hôpital Saint Louis
Paris, 75010
About this study
Official title: Targeted Intensification by a Preparative Regimen for Patients With High-grade B-Cell Lymphoma Utilizing Standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy (RIT) Combined With High-dose BEAM Followed by Autologous Stem Cell Transplantation (ASCT)
The purpose of this study is to evaluate the efficacy and the safety of a preparative regimen utilizing standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy combined with high-dose BEAM followed by ASCT after first line treatment in patients aged from 18 to 65 years with poor prognosis CD 20 Diffuse Large B-Cell lymphoma
- Conditions
- Lymphoma, Large Cell, Diffuse
- Being tested
- ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan), ASCT, Rituximab
- Keywords
- Lymphoma, Lymphoma Diffuse, B-Cell lymphoma, Aggressive lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan)Drug
Zevalin 0.4 mCi/kg: D-14 BCNU 300 mg/m² : D-6 Etoposide 100 mg/m²/12h : D-6 D-5 D-4 D-3 Aracytine 200 mg/m²/12h : D-6 D-5 D-4 D-3 Melphalan 140 mg/m²: D-2
ASCTProcedure or surgery
ASCT : D0
RituximabDrug
Rituximab 250 mg/m² :D-21 D-14
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan) ASCT Rituximab Receives: Drug: ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan); Procedure: ASCT; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival (EFS): events being death from any cause, relapse for complete responders and unconfirmed complete responders, progression during and after treatment and changes of therapy
Measured: 2 years
Secondary outcomes (1)
Overall response rate (ORR) (Complete Response CR and Partial Response PR)
100 days after ASCT
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startAug 2007
- Primary completionJan 2011
- Study completionJan 2014
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 Lymphoma, Large Cell, DiffuseStudies 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lymphoma Study Association
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Christian Gisselbrecht, MD, Principal investigator, Lymphoma Study AssociationChristophe Fruchart, MD, Principal investigator, Lymphoma Study Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689169
- Sponsor's protocol ID
- ZBEAM2
- Other IDs
- 2007-000270-23
- Acronym
- ZBEAM2
- Status last verified
- Mar 2018
- First submitted
- 29 May 2008
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Fruchart C, Tilly H, Morschhauser F, Ghesquieres H, Bouteloup M, Ferme C, Van Den Neste E, Bordessoule D, Bouabdallah R, Delmer A, Casasnovas RO, Ysebaert L, Ciappuccini R, Briere J, Gisselbrecht C. Upfront consolidation combining yttrium-90 ibritumomab tiuxetan and high-dose therapy with stem cell transplantation in poor-risk patients with diffuse large B cell lymphoma. Biol Blood Marrow Transplant. 2014 Dec;20(12):1905-11. doi: 10.1016/j.bbmt.2014.07.024. Epub 2014 Jul 26.
PubMed 25072780
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Intensification by a Preparative Regimen for Patients With High-grade B-Cell Lymphoma Utilizing Standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy (RIT) Combined With High-dose BEAM Followed by Autologous Stem Cell Transplantation (ASCT)
- ClinicalTrials.gov ID
- NCT00689169
- Acronym / sponsor ID
- ZBEAM2 / ZBEAM2
- Conditions
- Lymphoma, Large Cell, Diffuse
- Keywords
- Lymphoma, Lymphoma Diffuse, B-Cell lymphoma, Aggressive lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Lymphoma Study AssociationUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Aug 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 3 Jun 2008 (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.
The purpose of this study is to evaluate the efficacy and the safety of a preparative regimen utilizing standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy combined with high-dose BEAM followed by ASCT after first line treatment in patients aged from 18 to 65 years with poor prognosis CD 20 Diffuse Large B-Cell lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan), Procedure: ASCT, Drug: RituximabZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan) ASCT Rituximab |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aged from 18 to 65 years.
- Patient with pathologically proven, high grade B-cell Lymphoma CD 20 positive (WHO classification) :
- Diffuse large B cell lymphoma.
- Adverse prognostic factors IPI>1
- In Complete Remission, or partial response to first line treatment.
Key exclusion criteria (17 listed)
- Histological transformation in diffuse large B cell lymphoma, any type of low grade lymphoma
- More than one line of treatment. Prior transplantation. Prior exposure to Zevalin
- Central nervous system or meningeal involvement by lymphoma.
- Contraindication to any drug contained in the chemotherapy regimen.
- Any serious active disease or co-morbid medical condition (according to the investigator's decision and information provided in the IDB).
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 |
|---|---|---|
| ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan)Zevalin 0.4 mCi/kg: D-14 BCNU 300 mg/m² : D-6 Etoposide 100 mg/m²/12h : D-6 D-5 D-4 D-3 Aracytine 200 mg/m²/12h : D-6 D-5 D-4 D-3 Melphalan 140 mg/m²: D-2 | Drug | Experimental |
| ASCTASCT : D0 | Procedure or surgery | Experimental |
| RituximabRituximab 250 mg/m² :D-21 D-14 | Drug | Experimental |
Primary outcome
Event free survival (EFS): events being death from any cause, relapse for complete responders and unconfirmed complete responders, progression during and after treatment and changes of therapy
Time frame: 2 years
1 secondary outcome
Overall response rate (ORR) (Complete Response CR and Partial Response PR)
Time frame: 100 days
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 Mar 2018.
- Results publication: PubMed 25072780Fruchart C, Tilly H, Morschhauser F, Ghesquieres H, Bouteloup M, Ferme C, Van Den Neste E, Bordessoule D, Bouabdallah R, Delmer A, Casasnovas RO, Ysebaert L, Ciappuccini R, Briere J, Gisselbrecht C. Upfront consolidation combining yttrium-90 ibritumomab tiuxetan and high-dose therapy with stem cell transplantation in poor-risk patients with diffuse large B cell lymphoma. Biol Blood Marrow Transplant. 2014 Dec;20(12):1905-11. doi: 10.1016/j.bbmt.2014.07.024. Epub 2014 Jul 26.
- 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.
Christian Gisselbrecht, MD principal investigator
Lymphoma Study Association
Christophe Fruchart, MD principal investigator
Lymphoma Study Association
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 ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan), ASCT and Rituximab in people with Lymphoma, Large Cell, Diffuse, run by Lymphoma Study Association at 1 site in France.
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 12 inclusion and 17 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 Mar 2018. 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 France. 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 (EFS): events being death from any cause, relapse for complete responders and unconfirmed complete responders, progression during and after treatment and changes of therapy (time frame: 2 years). 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 NCT00689169, 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 7 Mar 2018.