Non-Hodgkins LymphomaPhase 2NCT00193440
Rituximab and Chemotherapy Followed by Ibritumomab Tiuxetan as Treatment for Low Grade Follicular Non-Hodgkin's Lymphoma
A Phase 2 study testing Rituximab, CHOP and CVP in people with Non-Hodgkins Lymphoma, run by SCRI Development Innovations, LLC.
Trial summary
In this trial, we will evaluate the feasibility, toxicity, and effectiveness ibritumomab tiuxetan, when incorporated into combination first-line treatment for follicular lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkins Lymphoma
- What is being tested?
- Rituximab, CHOP and CVP
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Jan 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be included in this study, you must meet the following criteria:
- Histologic documentation of follicular center, B-cell lymphoma
- Early stage lymphoma (stages I or II) relapsed after radiation therapy alone
- No previous chemotherapy or monoclonal antibody therapy
- Measurable or evaluable disease
- Able to perform activities of daily living with minimal assistance
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- Age > 18 years
- Adequate bone marrow ,liver and kidney function
- Must be accessible for treatment and follow-up.
- Bone marrow examination initial staging and accurate restaging
- All patients must give written informed consent prior to study entry.
Who cannot join
- You cannot participate in this study if any of the following apply to you:
- Small lymphocytic (CLL type) lymphomas and CLL
- Impaired bone marrow reserve
- Female pregnant or lactating
- Serious active infection at the time of treatment
- Any other serious underlying condition
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- Central nervous system involvement (brain or meningeal)
- HIV or AIDS-related lymphoma
- Received prior external beam radiation therapy to > 25% of active bone marrow
- Pleural effusion
- Received prior murine antibodies or proteins
- History of other neoplasms within five years of diagnosis
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
About this study
Official title: Phase II Trial of Rituximab and Short Duration Chemotherapy Followed by Zevalin as First-Line Treatment for Patients With Low Grade Follicular Non-Hodgkin's Lymphoma
In this trial, we will evaluate the feasibility, toxicity, and effectiveness ibritumomab tiuxetan, when incorporated into combination first-line treatment for follicular lymphoma. Addition of the ibritumomab tiuxetan to our previously evaluated, well tolerated combination of rituximab and short course chemotherapy will allow the use of additional active agent with a unique mechanism of cytotoxicity. In addition, "debulking" of lymphoma prior to 90Y Zevalin administration may minimize the myelotoxicity of this agent.
Read the detailed description
Upon determination of eligibility, patients will be receive:
- Rituxan + CHOP or CVP + Ibritumomab Tiuxetan
Patients who are considered medical candidates for doxorubicin should receive CHOP chemotherapy (Cyclophosphamide, doxorubicin, vincristine and prednisone). Patients who are not considered medical candidates for doxorubicin should receive CVP chemotherapy (Cyclophosphamide, Vincristine, and prednisone)
- Conditions
- Non-Hodgkins Lymphoma
- Being tested
- Rituximab, CHOP, CVP, Ibritumomab Tiuxetan
- 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.
RituximabDrug
CHOPDrug
CVPDrug
Ibritumomab TiuxetanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall clinical response rate
Overall molecular response rate
Secondary outcomes (3)
Progression-free survival
Overall survival
Overall toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startApr 2002
- Primary completionApr 2004
- Study completionJan 2009
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 Non-Hodgkins 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
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Investigators
- John D. Hainsworth, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193440
- Sponsor's protocol ID
- SCRI LYM 22
- Other IDs
- 106-PO69
- Status last verified
- Dec 2010
- First submitted
- 12 Sep 2005
- Last updated
- 30 Dec 2010
- Results posted
- No
Publications
Hainsworth JD, Spigel DR, Markus TM, Shipley D, Thompson D, Rotman R, Dannaher C, Greco FA. Rituximab plus short-duration chemotherapy followed by Yttrium-90 Ibritumomab tiuxetan as first-line treatment for patients with follicular non-Hodgkin lymphoma: a phase II trial of the Sarah Cannon Oncology Research Consortium. Clin Lymphoma Myeloma. 2009 Jun;9(3):223-8. doi: 10.3816/CLM.2009.n.044.
PubMed 19525191
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Rituximab and Short Duration Chemotherapy Followed by Zevalin as First-Line Treatment for Patients With Low Grade Follicular Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00193440
- Acronym / sponsor ID
- SCRI LYM 22
- Conditions
- Non-Hodgkins Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- Apr 2002
- Primary completion
- Apr 2004 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 19 Sep 2005 (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.
In this trial, we will evaluate the feasibility, toxicity, and effectiveness ibritumomab tiuxetan, when incorporated into combination first-line treatment for follicular lymphoma. Addition of the ibritumomab tiuxetan to our previously evaluated, well tolerated combination of rituximab and short course chemotherapy will allow the use of additional active agent with a unique mechanism of cytotoxicity. In addition, "debulking" of lymphoma prior to 90Y Zevalin administration may minimize the myelotoxicity of this agent.
Detailed description
Upon determination of eligibility, patients will be receive:
- Rituxan + CHOP or CVP + Ibritumomab Tiuxetan
Patients who are considered medical candidates for doxorubicin should receive CHOP chemotherapy (Cyclophosphamide, doxorubicin, vincristine and prednisone). Patients who are not considered medical candidates for doxorubicin should receive CVP chemotherapy (Cyclophosphamide, Vincristine, and prednisone)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologic documentation of follicular center, B-cell lymphoma
- Early stage lymphoma (stages I or II) relapsed after radiation therapy alone
- No previous chemotherapy or monoclonal antibody therapy
- Measurable or evaluable disease
- Able to perform activities of daily living with minimal assistance
Key exclusion criteria (13 listed)
- Small lymphocytic (CLL type) lymphomas and CLL
- Impaired bone marrow reserve
- Female pregnant or lactating
- Serious active infection at the time of treatment
- Any other serious underlying condition
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 |
|---|---|---|
| Rituximab | Drug | – |
| CHOP | Drug | – |
| CVP | Drug | – |
| Ibritumomab Tiuxetan | Drug | – |
Primary outcome
Overall clinical response rate
Overall molecular response rate
3 secondary outcomes
Progression-free survival
Overall survival
Overall toxicity
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 Dec 2010.
- Results publication: PubMed 19525191Hainsworth JD, Spigel DR, Markus TM, Shipley D, Thompson D, Rotman R, Dannaher C, Greco FA. Rituximab plus short-duration chemotherapy followed by Yttrium-90 Ibritumomab tiuxetan as first-line treatment for patients with follicular non-Hodgkin lymphoma: a phase II trial of the Sarah Cannon Oncology Research Consortium. Clin Lymphoma Myeloma. 2009 Jun;9(3):223-8. doi: 10.3816/CLM.2009.n.044.
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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.
John D. Hainsworth, MD principal investigator
SCRI Development Innovations, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab, CHOP and CVP in people with Non-Hodgkins Lymphoma, run by SCRI Development Innovations, LLC.
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 11 inclusion and 13 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 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall clinical response rate. The study lists 2 primary outcomes in all. 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 NCT00193440, 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 30 Dec 2010.