Non-Hodgkin's LymphomaPhase 3NCT00491491
Zevalin-beam for Aggressive Lymphoma
A Phase 3 study testing ibritumomab tiuxetan and BEAM chemotherapy and autologous stem-cell transplantation in people with Non-Hodgkin's Lymphoma, run by Sheba Medical Center at 9 sites in 4 countries.
Trial summary
The study hypothesis is that the addition of zevalin radioimmunotherapy to the conditioning regimen given prior to BEAM high-dose chemotherapy and autologous stem cell transplantation in patients with aggressive lymphoma will reduced disease recurrence rate and improve overall and disease-free survival. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- ibritumomab tiuxetan and BEAM chemotherapy and autologous stem-cell transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Jun 2007to Feb 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with CD20 positive diffuse large B-cell lymphoma as confirmed by a pathological biopsy report.
- Patients who are candidates for autologous stem-cell transplantation due to primary refractory or first relapse of disease.
- Patients must have chemo-sensitive disease achieving at least partial response (Cheson 2007 criteria) to last chemotherapy.
- Age ≥ 18 years and age ≤ 70
- Patients with adequate autologous stem cell collection for transplantation (target ≥ 2.5 x 106 CD34+ cells/kg).
- Patients must sign written informed consent.
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- Adequate birth control in fertile patients.
- All prior chemotherapy completed at least three weeks before study treatment.
- Marrow involvement less than 25% at transplantation, no limitation on blood counts (low platelet count allowed).
- Negative HIV antibody.
Who cannot join
- 1. Chemo-refractory disease as determined by less than partial response (Cheson 2007 Criteria) to last chemotherapy.
- Two or more relapses after initial response to induction chemotherapy.
- High-grade transformation from earlier diagnosis of low-grade lymphoma. Patients with "De Novo" Transformed DLBCL, defined as DLBCL only on lymph node biopsy and a discordant marrow with para-trabecular small cells at first diagnosis of lymphoma, are eligible if adherent all other selection criteria.
- Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit.
- Creatinine > 2.0 mg/dl.
- ECOG Performance status > 2.
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- Uncontrolled infection.
- Pregnancy or lactation.
- Abnormal lung diffusion capacity (DLCO < 40% predicted).
- Severe cardiovascular disease; New York Heart Association (NYHA) Functional Classification ≥2.
- Active CNS disease involvement.
- Presence of any other malignancy or history of prior malignancy within 5 years of study entry. Within 5 years, patients treated for Stage I or II cancers are eligible provided they have a life expectancy > 5 years in relation to this prior malignance. The 5-year exclusion rule does not apply to-non melanoma skin tumors and in situ cervical cancer.
- Pleural effusion or ascites > 1 liter.
- Known hypersensitivity to rituximab.
- Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate.
- Prior radioimmunotherapy.
- Prior autologous or allogeneic HSCT.
- Active evidence of Hepatitis B or C infection; Hepatitis B surface antigen positive.
- Patients who have had prior radiation to the lung will be excluded from the study, although mediastinal irradiation will be permitted if minimal lung is in the treatment volume.
- Patients who have received >500cGy radiation to the kidneys will be excluded from the study.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
United States6 sites
Northwestern University
Chicago, Illinois
City of Hope National Medical Center
Duarte, California, 91010-3000
Cedars Sinai Medical Center
Los Angeles, California
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic Arizona
Scottsdale, Arizona
Moffitt Cancer Center
Tampa, Florida
About this study
Official title: SPINOZA / שפינוזה. Study With Preparatory INduction Of Zevalin in Aggressive Lymphoma. A Randomized Phase 3 Study of BEAM Versus 90Yttrium Ibritumomab Tiuxetan (Zevalin) / BEAM in Patients Requiring Autologous Hematopoietic Stem Cell Transplantation (ASCT) for Relapsed Diffuse Large B-cell Lymphoma
The study hypothesis is that the addition of zevalin radioimmunotherapy to the conditioning regimen given prior to BEAM high-dose chemotherapy and autologous stem cell transplantation in patients with aggressive lymphoma will reduced disease recurrence rate and improve overall and disease-free survival.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- ibritumomab tiuxetan, BEAM chemotherapy and autologous stem-cell transplantation
- Keywords
- non-Hodgkin's lymphoma, autologous stem cell transplantation, radioimmunotherapy, zevalin
- 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.
ibritumomab tiuxetanDrug
Also called zevalin
0.4 mCi/kg
BEAM chemotherapy and autologous stem-cell transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Z-BEAM | Experimental | ibritumomab tiuxetan (zevalin) BEAM Receives: Drug: ibritumomab tiuxetan; Procedure: BEAM chemotherapy and autologous stem-cell transplantation |
| standard BEAM | Active comparator | standard BEAM chemotherapy Receives: Procedure: BEAM chemotherapy and autologous stem-cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
actuarial 2 year survival
Measured: 2 years after transplantation
Secondary outcomes (5)
Progression-free Survival
actuarial 2-year PFS
Measured: 2 years after transplantation
Clinical Response
complete response (CR) and partial response (PR) proportion at day 100,
Measured: 100 days after transplantation
Hematopoietic Recovery
time to hematopoietic recovery
Measured: 100 days after transplantation
Grade III Toxicity
incidence of infection, grade III-IV toxicities, treatment-related mortality
Measured: 100 days after transplantation
Secondary Malignancies
incidence of myelodysplastic syndrome (MDS), and secondary acute myelogenous leukemia (AML).
Measured: 5 years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Hodgkin's 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- City of Hope Medical Center, Amsterdam UMC, location VUmc, University of Göttingen
- Responsible party
- Principal investigator, Dr. Avichai Shimoni MD, Sheba Medical Center
- Investigators
- Avichai Shimoni, MD, Study chair, Chaim Sheba Medical Center, Tel Hashomer, IsraelAmrita Krishnan, MD, Study chair, City of Hope National Medical Center, Duarte, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491491
- Sponsor's protocol ID
- SHEBA-07-4466-AN-CTIL
- Status last verified
- Aug 2020
- First submitted
- 25 Jun 2007
- Last updated
- 31 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPINOZA / שפינוזה. Study With Preparatory INduction Of Zevalin in Aggressive Lymphoma. A Randomized Phase 3 Study of BEAM Versus 90Yttrium Ibritumomab Tiuxetan (Zevalin) / BEAM in Patients Requiring Autologous Hematopoietic Stem Cell Transplantation (ASCT) for Relapsed Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT00491491
- Acronym / sponsor ID
- SHEBA-07-4466-AN-CTIL
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- non-Hodgkin's lymphoma, autologous stem cell transplantation, radioimmunotherapy, zevalin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- City of Hope Medical Center, Amsterdam UMC, location VUmc, University of Göttingen
- Study start
- Jun 2007
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 26 Jun 2007 (estimated)
- Results
- Posted 31 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study hypothesis is that the addition of zevalin radioimmunotherapy to the conditioning regimen given prior to BEAM high-dose chemotherapy and autologous stem cell transplantation in patients with aggressive lymphoma will reduced disease recurrence rate and improve overall and disease-free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Z-BEAM | Experimental | Drug: ibritumomab tiuxetan, Procedure: BEAM chemotherapy and autologous stem-cell transplantationibritumomab tiuxetan (zevalin) BEAM |
| standard BEAM | Active comparator | Procedure: BEAM chemotherapy and autologous stem-cell transplantationstandard BEAM chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with CD20 positive diffuse large B-cell lymphoma as confirmed by a pathological biopsy report.
- Patients who are candidates for autologous stem-cell transplantation due to primary refractory or first relapse of disease.
- Patients must have chemo-sensitive disease achieving at least partial response (Cheson 2007 criteria) to last chemotherapy.
- Age ≥ 18 years and age ≤ 70
- Patients with adequate autologous stem cell collection for transplantation (target ≥ 2.5 x 106 CD34+ cells/kg).
Key exclusion criteria (20 listed)
- 1. Chemo-refractory disease as determined by less than partial response (Cheson 2007 Criteria) to last chemotherapy.
- Two or more relapses after initial response to induction chemotherapy.
- High-grade transformation from earlier diagnosis of low-grade lymphoma. Patients with "De Novo" Transformed DLBCL, defined as DLBCL only on lymph node biopsy and a discordant marrow with para-trabecular small cells at first diagnosis of lymphoma, are eligible if adherent all other selection criteria.
- Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit.
- Creatinine > 2.0 mg/dl.
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 |
|---|---|---|
| ibritumomab tiuxetanAlso: zevalin0.4 mCi/kg | Drug | Z-BEAM |
| BEAM chemotherapy and autologous stem-cell transplantation | Procedure or surgery | Z-BEAM, standard BEAM |
Primary outcome
Overall Survival
Time frame: 2 years after transplantation
actuarial 2 year survival
5 secondary outcomes
Progression-free Survival
Time frame: 2 years after transplantation
Clinical Response
Time frame: 100 days after transplantation
Hematopoietic Recovery
Time frame: 100 days after transplantation
Grade III Toxicity
Time frame: 100 days after transplantation
Secondary Malignancies
Time frame: 5 years after transplantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Avichai Shimoni, MD study chair
Chaim Sheba Medical Center, Tel Hashomer, Israel
Amrita Krishnan, MD study chair
City of Hope National Medical Center, Duarte, CA
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ibritumomab tiuxetan and BEAM chemotherapy and autologous stem-cell transplantation in people with Non-Hodgkin's Lymphoma, run by Sheba Medical Center at 9 sites in 4 countries.
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 20 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 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Germany, Israel, Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival (time frame: 2 years after transplantation). 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 31 Aug 2020.