Non-Hodgkin's LymphomaPhase 2ZevalinNCT00438581
Study Combining Zevalin With High-Dose Chemotherapy Prior to Autologous StemCell Transplant in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma
A Phase 2 study testing Yttrium 90 Ibritumomab Tiuxetan ( Zevalin ) in people with Non-Hodgkin's Lymphoma, run by McGill University at 1 site in Canada.
Trial summary
This aim of this study to evaluate the safety and efficacy of combining a single course of Yttrium 90 Ibritumomab Tiuxetan, a radiolabeled monoclonal antibody ( Zevalin ), with high-dose BEAM chemotherapy and autologous peripheral stem cell transplantation in patients with relapsed, refractory, or transformed… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Yttrium 90 Ibritumomab Tiuxetan ( Zevalin )
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2007to not given
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >=18 to <=70 years
- Relapsed or refractory Stage III or IV, grade 1,2, or 3 Follicular Lymphoma or transformed follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, Waldenstrom's macroglobulinemia, or diffuse large B-Cell lymphoma as defined by the WHO and:
- Expressing the CD 20 antigen
- ECOG performance 0-2
- Written informed consent
- Prior collection of at least 2.5x10^6 CD34-positive peripheral blood stem cells/kg.
Who cannot join
- Abnormal renal function (Creatinine >2.5x upper limit of normal (ULN)
- Abnormal hepatic function (Bilirubin >2xULN, ALT/AST >3x ULN)
- Cardiac ejection fraction <40%
- Severe defects in pulmonary function tests (DLCO<70% predicted, FEV1, FVC<60% predicted) or receiving continuous oxygen
- A history of human anti-mouse antibodies (HAMA) or known type 1 hypersensitivity or anaphylactic proteins to any component of the Zevalin therapy.
- Female patients who are pregnant or breast feeding, and adults of reproductive potential who are not employing an effective method of birth control during study treatment
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- Prior radiotherapy to >25% of the bone marrow or >20 Gy to critical organ (lung, liver, kidney, spinal cord).
- CNS lymphoma
- Ongoing infection
- Prior treatment with radioimmunotherapy
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University Health Center, Royal Victoria Hospital
Montreal, Quebec, H3A1A1
Ahmed Galal, MD, 514-934-1934 ext. 31558, galala@muhchem.mcgill.ca
Ahmed Galal, MD
About this study
Official title: Phase II Non-Randomized Study Combining Yttrium 90 Ibritumomab Tiuxetan (Zevalin) With High-Dose Chemotherapy Prior to Autologous Stem Cell Transplantation in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma
This aim of this study to evaluate the safety and efficacy of combining a single course of Yttrium 90 Ibritumomab Tiuxetan, a radiolabeled monoclonal antibody ( Zevalin ), with high-dose BEAM chemotherapy and autologous peripheral stem cell transplantation in patients with relapsed, refractory, or transformed Non-Hodgkin's lymphoma.
Read the detailed description
Relapse rates after chemotherapy for relapsed, refractory or transformed Non-Hodgkin's lymphoma (NHL)remain very high. NHL is a radiosensitive tumor. We hypothesize that targeted radioimmunotherapy combined with high-dose chemotherapy may increase response and survival rates in a safe and reliable manner.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Yttrium 90 Ibritumomab Tiuxetan ( Zevalin )
- Keywords
- Zevalin, Autologous one Marrow Transplant, Non-Hodgkin's Lymphoma
- 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.
Yttrium 90 Ibritumomab Tiuxetan ( Zevalin )Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Secondary outcomes (1)
Survival Data, adverse events, molecular response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Ahmed Galal, MD, Principal investigator, McGill University Health Center, Royal Victoria Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438581
- Sponsor's protocol ID
- BMA-05-017-ZEV
- Acronym
- Zevalin
- Status last verified
- Feb 2007
- First submitted
- 20 Feb 2007
- Last updated
- 27 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Non-Randomized Study Combining Yttrium 90 Ibritumomab Tiuxetan (Zevalin) With High-Dose Chemotherapy Prior to Autologous Stem Cell Transplantation in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00438581
- Acronym / sponsor ID
- Zevalin / BMA-05-017-ZEV
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- Zevalin, Autologous one Marrow Transplant, Non-Hodgkin's Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- Mar 2007
- First posted
- 22 Feb 2007 (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.
This aim of this study to evaluate the safety and efficacy of combining a single course of Yttrium 90 Ibritumomab Tiuxetan, a radiolabeled monoclonal antibody ( Zevalin ), with high-dose BEAM chemotherapy and autologous peripheral stem cell transplantation in patients with relapsed, refractory, or transformed Non-Hodgkin's lymphoma.
Detailed description
Relapse rates after chemotherapy for relapsed, refractory or transformed Non-Hodgkin's lymphoma (NHL)remain very high. NHL is a radiosensitive tumor. We hypothesize that targeted radioimmunotherapy combined with high-dose chemotherapy may increase response and survival rates in a safe and reliable manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >=18 to <=70 years
- Relapsed or refractory Stage III or IV, grade 1,2, or 3 Follicular Lymphoma or transformed follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, Waldenstrom's macroglobulinemia, or diffuse large B-Cell lymphoma as defined by the WHO and:
- Prior collection of at least 2.5x10^6 CD34-positive peripheral blood stem cells/kg.
Key exclusion criteria (10 listed)
- Abnormal renal function (Creatinine >2.5x upper limit of normal (ULN)
- Abnormal hepatic function (Bilirubin >2xULN, ALT/AST >3x ULN)
- Cardiac ejection fraction <40%
- Severe defects in pulmonary function tests (DLCO<70% predicted, FEV1, FVC<60% predicted) or receiving continuous oxygen
- A history of human anti-mouse antibodies (HAMA) or known type 1 hypersensitivity or anaphylactic proteins to any component of the Zevalin therapy.
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 |
|---|---|---|
| Yttrium 90 Ibritumomab Tiuxetan ( Zevalin ) | Drug | – |
Primary outcome
Overall response rate
1 secondary outcome
Survival Data, adverse events, molecular response
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2007.
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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.
Ahmed Galal, MD principal investigator
McGill University Health Center, Royal Victoria 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 Yttrium 90 Ibritumomab Tiuxetan ( Zevalin ) in people with Non-Hodgkin's Lymphoma, run by McGill University at 1 site in Canada.
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 6 inclusion and 10 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 27 Feb 2007. 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 Canada. 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 Ahmed Galal, MD (514-934-1934 ext. 31558, galala@muhchem.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate. 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 27 Feb 2007.