Diffuse Large B-cell LymphomaPhase 2NCT00440583
The Response Study of Yt90-Zevalin in Patients With Diffuse Large B-cell Lymphoma After 6 Cycles of CHOP
A Phase 2 study testing chemotherapy followed by Zevalin in people with Diffuse Large B-cell Lymphoma, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine the effective of Yt90-Zevalin therapy in patients with diffuse large B-cell lymphoma that have achieved at least an unconfirmed partial remission after 6 cycles of CHOP therapy. 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?
- chemotherapy followed by Zevalin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2006to May 2012
- 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, CD 20 positive diffuse large B-cell lymphoma, meeting 1 of the following stage criteria: Bulky stage II disease, Stage III disease, Stage IV disease at the initial diagnosis.
- Bidimensionally measurable disease
- Age 18 - 75 Years
- Performance status Zubrod 0-2
- Less than 20,000/mcL circulating lymphoid cells on WBC differential count
- Adequate sections AND a paraffin block OR ≥ 10 unstained sections from the original diagnostic specimen available
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- Needle aspiration or cytology are not considered adequate
- No clinical evidence of CNS involvement by lymphoma
- No prior diagnosis of indolent lymphoma
- No histologic transformation
- Life expectancy : Not specified
- Hepatic : Not specified
- Renal : Not specified
- Cardiovascular
- Ejection fraction ≥ 45% by MUGA OR
- No significant abnormalities by echocardiogram
- Pulmonary : No requirement for continuous supplemental oxygen
- Other
- All adult patients of reproductive potential must use contraception during and for 6 months after completion of study treatment
- No other malignancy within the 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 the cervix
- No known HIV positive
- Written informed consent
- PRIOR CONCURRENT THERAPY:
- Biologic therapy : No prior antibody therapy for lymphoma
- Chemotherapy : 6 cycles of CHOP
- Endocrine therapy : Not specified
- Radiotherapy : No prior radiotherapy for lymphoma
- Surgery : No prior solid organ transplantation
Who cannot join
- Previous antineoplastic treatment other than the 6 cycles of CHOP for the initial treatment of DLBCL
- Positive HIV serology
- Positive serology of HCV with the presence of HCV RNA of chronic hepatitis
- Positive serology of HBV with the presence of HBV RNA of chronic hepatitis
- Serum creatinine or bilirubin > 2.5 x upper limit of normal
- Active uncontrolled infection
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- Concurrent severe and/or uncontrolled medical disease which could compromise the participation in the study
- Patients in whom more than 25% of the bone marrow has been infiltrated by lymphoma cells
- Patients with platelet counts <100,000/µl or neutrophil counts < 1500/µl
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, 10700
About this study
Official title: Yt90 Zevalin & Combination Chemotherapy in Treating Patients With Stage II,Stage III,or Stage IV Diffuse Large B-cell Lymphoma
The purpose of this study is to determine the effective of Yt90-Zevalin therapy in patients with diffuse large B-cell lymphoma that have achieved at least an unconfirmed partial remission after 6 cycles of CHOP therapy.
Read the detailed description
Diffuse large B-cell lymphomas (DLBCL) are the most common lymphoid neoplasm and account for 30% to 40% of adult non-Hodgkin lymphomas (NHL). DLCBL is a potentially curable disease. The ultimate goals of introducing new modality treatments such as monoclonal antibody (Ab)-targeted therapy are to increase complete remission (CR) rate and prolong event-free survival and overall survival.In phase II trials, it was shown that in DLBL the addition of rituximab to CHOP was feasible, with an increase in ORR, including CR and an increase in the OS and PFS in patients with DLBL.2 The benefit of R-CHOP was consistent across all subgroups of patients tested, including good and poor risks according to IPI and independent of younger than 70 years and older than 70 years of age.
Recently, new radiolabeled monoclonal antibodies have been established in the therapy of malignant lymphoma which can induce high remission rates. Radiolabeled antibodies are particularly effective as lymphoma cells are highly sensitive to radiation. In addition, the local emission of radiolabeled antibodies is able to destroy cells in close proximity to the bound antibody (bystander effect) therefore circumventing the problem of limited perfusion of bulky or poorly vascularized tumors.Ibritumomab is covalently linked to the tiuxetan chelate and radiolabeled with Yt90, producing Yt90-ibritumomab tiuxetan (Yt90-Zevalin). To optimize biodistribution, Rituximab is given prior to the radiolabeled antibody. Yt90-ibritumomab-tiuxetan-treatment was compared to a standard course of Rituximab. ORR in the Yt90-ibritumomab tiuxetan group was significantly higher than ORR in the Rituximab group (80% vs. 56% according to International Workshop Response criteria or 73% vs. 47% according to protocol-defined evaluation of response).
Since radioimmunotherapy represents a significant advance over unlabeled immunotherapy for the treatment of patients with B-cell non-Hodgkin's lymphoma, it is worthwhile to study the consolidation therapy with Yt90-ibritumomab tiuxetan (Yt90-Zevalin) in patients who achieved at least unconfirmed partial remission after 6 cycles of CHOP therapy.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- chemotherapy followed by Zevalin
- Keywords
- CHOP-Z
- 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.
chemotherapy followed by ZevalinDrug
6 cycles of chemotherapy with CHOP (Cyclophosphamide iv 750 mg/m2 over 15-45 minutes; Doxorubicin iv 50 mg/m2 over 5-20 minutes; and Vincristine iv 1.4 mg/m2 over 5-15 minutes on day 1 and oral prednisone 40 mg/m2 on days 1-5 repeated every 21 days), followed by Zevalin
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy followed by Zevalin | Experimental | 6 cycles of chemotherapy with CHOP (Cyclophosphamide iv 750 mg/m2 over 15-45 minutes; Doxorubicin iv 50 mg/m2 over 5-20 minutes; and Vincristine iv 1.4 mg/m2 over 5-15 minutes on day 1 and oral prednisone 40 mg/m2 on days 1-5 repeated every 21 days), followed by Zevalin Receives: Drug: chemotherapy followed by Zevalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Determine the 2-years progression-free survival of consolidation therapy with Yt90-Zevalin.
Measured: 2 year
Secondary outcomes (2)
Determine the response duration(time to progression)after therapy.
Measured: 2 year
Determine safety and tolerability of Yt90-Zevalin consolidation therapy.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startSep 2006
- Primary completionSep 2011
- Study completionMay 2012
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 Mahidol 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Surapol Issaragrisil, M.D., Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440583
- Sponsor's protocol ID
- TH011101
- Status last verified
- Jan 2015
- First submitted
- 26 Feb 2007
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yt90 Zevalin & Combination Chemotherapy in Treating Patients With Stage II,Stage III,or Stage IV Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT00440583
- Acronym / sponsor ID
- TH011101
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- CHOP-Z
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Sep 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 27 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.
The purpose of this study is to determine the effective of Yt90-Zevalin therapy in patients with diffuse large B-cell lymphoma that have achieved at least an unconfirmed partial remission after 6 cycles of CHOP therapy.
Detailed description
Diffuse large B-cell lymphomas (DLBCL) are the most common lymphoid neoplasm and account for 30% to 40% of adult non-Hodgkin lymphomas (NHL). DLCBL is a potentially curable disease. The ultimate goals of introducing new modality treatments such as monoclonal antibody (Ab)-targeted therapy are to increase complete remission (CR) rate and prolong event-free survival and overall survival.In phase II trials, it was shown that in DLBL the addition of rituximab to CHOP was feasible, with an increase in ORR, including CR and an increase in the OS and PFS in patients with DLBL.2 The benefit of R-CHOP was consistent across all subgroups of patients tested, including good and poor risks according to IPI and independent of younger than 70 years and older than 70 years of age.
Recently, new radiolabeled monoclonal antibodies have been established in the therapy of malignant lymphoma which can induce high remission rates. Radiolabeled antibodies are particularly effective as lymphoma cells are highly sensitive to radiation. In addition, the local emission of radiolabeled antibodies is able to destroy cells in close proximity to the bound antibody (bystander effect) therefore circumventing the problem of limited perfusion of bulky or poorly vascularized tumors.Ibritumomab is covalently linked to the tiuxetan chelate and radiolabeled with Yt90, producing Yt90-ibritumomab tiuxetan (Yt90-Zevalin). To optimize biodistribution, Rituximab is given prior to the radiolabeled antibody. Yt90-ibritumomab-tiuxetan-treatment was compared to a standard course of Rituximab. ORR in the Yt90-ibritumomab tiuxetan group was significantly higher than ORR in the Rituximab group (80% vs. 56% according to International Workshop Response criteria or 73% vs. 47% according to protocol-defined evaluation of response).
Since radioimmunotherapy represents a significant advance over unlabeled immunotherapy for the treatment of patients with B-cell non-Hodgkin's lymphoma, it is worthwhile to study the consolidation therapy with Yt90-ibritumomab tiuxetan (Yt90-Zevalin) in patients who achieved at least unconfirmed partial remission after 6 cycles of CHOP therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chemotherapy followed by Zevalin | Experimental | Drug: chemotherapy followed by Zevalin6 cycles of chemotherapy with CHOP (Cyclophosphamide iv 750 mg/m2 over 15-45 minutes; Doxorubicin iv 50 mg/m2 over 5-20 minutes; and Vincristine iv 1.4 mg/m2 over 5-15 minutes on day 1 and oral prednisone 40 mg/m2 on days 1-5 repeated every 21 days), followed by Zevalin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Histologically confirmed, CD 20 positive diffuse large B-cell lymphoma, meeting 1 of the following stage criteria: Bulky stage II disease, Stage III disease, Stage IV disease at the initial diagnosis.
- Bidimensionally measurable disease
- Age 18 - 75 Years
- Performance status Zubrod 0-2
- Less than 20,000/mcL circulating lymphoid cells on WBC differential count
Key exclusion criteria (9 listed)
- Previous antineoplastic treatment other than the 6 cycles of CHOP for the initial treatment of DLBCL
- Positive HIV serology
- Positive serology of HCV with the presence of HCV RNA of chronic hepatitis
- Positive serology of HBV with the presence of HBV RNA of chronic hepatitis
- Serum creatinine or bilirubin > 2.5 x upper limit of normal
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 |
|---|---|---|
| chemotherapy followed by Zevalin6 cycles of chemotherapy with CHOP (Cyclophosphamide iv 750 mg/m2 over 15-45 minutes; Doxorubicin iv 50 mg/m2 over 5-20 minutes; and Vincristine iv 1.4 mg/m2 over 5-15 minutes on day 1 and oral prednisone 40 mg/m2 on days 1-5 repeated every 21 days), followed by Zevalin | Drug | chemotherapy followed by Zevalin |
Primary outcome
- Determine the 2-years progression-free survival of consolidation therapy with Yt90-Zevalin.
Time frame: 2 year
2 secondary outcomes
Determine the response duration(time to progression)after therapy.
Time frame: 2 year
Determine safety and tolerability of Yt90-Zevalin consolidation therapy.
Time frame: 2 year
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 30 Jan 2015.
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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.
Surapol Issaragrisil, M.D. principal investigator
Siriraj 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 chemotherapy followed by Zevalin in people with Diffuse Large B-cell Lymphoma, run by Mahidol 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 28 inclusion and 9 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 30 Jan 2015. 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 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?
- Determine the 2-years progression-free survival of consolidation therapy with Yt90-Zevalin. (time frame: 2 year). 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 30 Jan 2015.