Diffuse Large B-cell LymphomaPhase 2NCT00386321
Yt90 Zevalin and Combination Chemotherapy (Z-CHOP)in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-cell Lymphoma
A Phase 2 study testing Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin) in people with Diffuse Large B-cell Lymphoma, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether the treatment of Yt90 Zevalin in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone)are effective as first line treatment in patients with bulky stage II or stage III or IV diffuse large B-cell lymphoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin)
- How many people
- 10 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2006to Jan 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed CD20 positive diffuse large B-cell lymphoma with bulky stage II or stage III or stage IV
- Bidimensionally measurable disease
- Performance status Zubrod 0-2
- Less than 20,000/mcL circulating lymphoid cells on WBC differential count
- No clinical evidence of CNS involvement, no prior diagnosis of indolent lymphoma, no histologic transformation
- Ejection fraction more than or equal to 45% by MUGA or no significant abnormality by echocardiogram
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- Fertile patients with effective contraception method
- No other malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, stage I or II cancer in complete remission, or carcinoma in situ of cervix
- No HIV positive, no prior solid organ transplantation
- No prior antibody therapy, chemotherapy, radiotherapy for lymphoma
Who cannot join
- Serum creatinine ot bilirubin more than 2.5 X ULN unless due to lymphoma
- Active uncontrolled infection
- Concurrent severe and/or uncontrolled medical disease which could compromise participation in the study
- Patients with more than 25% infiltrated bone marrow
- Patients with platelet counts less than 100,000/mcL or neutrophil counts less than 1,500/mcL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Yt90Zevalin Plus CHOP, Z-CHOP
The purpose of this study is to determine whether the treatment of Yt90 Zevalin in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone)are effective as first line treatment in patients with bulky stage II or stage III or IV diffuse large B-cell lymphoma
Read the detailed description
Radioimmunotherapy represents a significant advance over unlabeled immunotherapy for the treatment of patients with B-cell non-Hodgkin's lymphoma. The radiobiological effects associated with Yt90-labelled ibritumomab tiuxetan (Zevalin) include the induction of apoptosis and cell-cycle redistribution.
The response rate tend to be higher in patients who have been treated with fewer prior therapies and Yt90-labelled ibritumomab tiuxetan may be suitable for use early in the course of therapy.
Yt90-labelled ibritumomab tiuxetan has less non hematologic toxicity than chemotherapy, with only minimal alopecia, mucositis, nausea, or vomiting, and a lower incidence of infections.
Yt90-labelled ibritumomab tiuxetan regimen is routinely and safely given in an outpatient setting and is completed in 7-9 days and is thus more convenient to be used.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin)
- Keywords
- Zevalin, Zevalin plus CHOP, Diffuse large B-cell lymphoma, First line Diffuse large B-cell lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yttrium 90 -labeled ibritumomab tiuxetan (Zevalin)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression-free survival and overall survival of patients
Secondary outcomes (2)
Response rate (partial response, complete unconfirmed response, and complete response)in patients
2-year progression-free survival, overall survival and response rate in BCL-2 positive patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startApr 2006
- Primary completionJul 2007
- Study completionJan 2010 (estimated)
Why it stopped: Participants are no longer being examined or treated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Investigators
- Udomsak Bunworasate, M.D., Principal investigator, Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386321
- Sponsor's protocol ID
- TH011103
- Status last verified
- Nov 2010
- First submitted
- 10 Oct 2006
- Last updated
- 18 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yt90Zevalin Plus CHOP, Z-CHOP
- ClinicalTrials.gov ID
- NCT00386321
- Acronym / sponsor ID
- TH011103
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- Zevalin, Zevalin plus CHOP, Diffuse large B-cell lymphoma, First line Diffuse large B-cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participants are no longer being examined or treated.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Apr 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jan 2010 (estimated)
- First posted
- 11 Oct 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.
The purpose of this study is to determine whether the treatment of Yt90 Zevalin in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone)are effective as first line treatment in patients with bulky stage II or stage III or IV diffuse large B-cell lymphoma
Detailed description
Radioimmunotherapy represents a significant advance over unlabeled immunotherapy for the treatment of patients with B-cell non-Hodgkin's lymphoma. The radiobiological effects associated with Yt90-labelled ibritumomab tiuxetan (Zevalin) include the induction of apoptosis and cell-cycle redistribution.
The response rate tend to be higher in patients who have been treated with fewer prior therapies and Yt90-labelled ibritumomab tiuxetan may be suitable for use early in the course of therapy.
Yt90-labelled ibritumomab tiuxetan has less non hematologic toxicity than chemotherapy, with only minimal alopecia, mucositis, nausea, or vomiting, and a lower incidence of infections.
Yt90-labelled ibritumomab tiuxetan regimen is routinely and safely given in an outpatient setting and is completed in 7-9 days and is thus more convenient to be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed CD20 positive diffuse large B-cell lymphoma with bulky stage II or stage III or stage IV
- Bidimensionally measurable disease
- Performance status Zubrod 0-2
- Less than 20,000/mcL circulating lymphoid cells on WBC differential count
- No clinical evidence of CNS involvement, no prior diagnosis of indolent lymphoma, no histologic transformation
Key exclusion criteria (5 listed)
- Serum creatinine ot bilirubin more than 2.5 X ULN unless due to lymphoma
- Active uncontrolled infection
- Concurrent severe and/or uncontrolled medical disease which could compromise participation in the study
- Patients with more than 25% infiltrated bone marrow
- Patients with platelet counts less than 100,000/mcL or neutrophil counts less than 1,500/mcL
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 -labeled ibritumomab tiuxetan (Zevalin) | Drug | – |
Primary outcome
2-year progression-free survival and overall survival of patients
2 secondary outcomes
Response rate (partial response, complete unconfirmed response, and complete response)in patients
2-year progression-free survival, overall survival and response rate in BCL-2 positive patients
Results and safety
The study was stopped early (reason given: Participants are no longer being examined or treated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2010.
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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.
Udomsak Bunworasate, M.D. principal investigator
Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University
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 -labeled ibritumomab tiuxetan (Zevalin) in people with Diffuse Large B-cell Lymphoma, run by Chulalongkorn University at 1 site in Thailand.
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 5 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: stopped early, as of the sponsor's last update on 18 Nov 2010. 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 Thailand. 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 was stopped early (reason given: Participants are no longer being examined or treated.). Results are not available in the source record.
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?
2-year progression-free survival and overall survival of patients. 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 18 Nov 2010.