Non-Hodgkin LymphomaPhase 2NCT00177554
Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma
A Phase 2 study testing Chemotherapy and Radioimmunotherapy in people with Non-Hodgkin Lymphoma, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to determine the complete response rate when CHOP-R chemotherapy in followed by Zevalin in previous untreated patients with follicular lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma
- What is being tested?
- Chemotherapy and Radioimmunotherapy
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to May 2007
- 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
- Conformed diagnosis of follicular lymphoma, grades 1,2 or 3
- No prior chemotherapy
- No prior monoclonal antibody therapy
- Bulky or symptomatic disease, stage II-IV
- Performance status 0-2
Who cannot join
- Impaired bone marrow reserve
- Presence of CNS lymphoma
- Serious nonmalignant disease or active infection
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the complete response rate when CHOP-R chemotherapy in followed by Zevalin in previous untreated patients with follicular lymphoma
Read the detailed description
Patients with follicular lymphoma who require therapy and have been previously untreated are eligible for this non-randomized, phase II study evaluating up front therapy with CHOP-R x 3 cycles followed by zevalin and 4 additional weeks of rituxan.The complete response will be determined by combining IWC criteria and PET scanning.Secondary objectives include PET-CT conversion rate, frequency and severity of adverse events, duration of complete remission and time to next lymphoma therapy.
- Conditions
- Non-Hodgkin Lymphoma
- Being tested
- Chemotherapy and Radioimmunotherapy
- Keywords
- Non-Hodgkin 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.
Chemotherapy and RadioimmunotherapyDrug
CHOP-R x 3 cycles followed by zevalin and extended rituximab
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Measured: May 2007,May 2008, May2009, May 2010
Secondary outcomes (4)
PET-CT conversion rate
Measured: May2007
Frequency and severity of adverse events
Measured: May 2007
Duration of complete response
Measured: May 2007,May 2008, May 2009, May 2010
Time to next lymphoma therapy
Measured: May 2207,May2008,May2009, May2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startNov 2003
- Primary completionMay 2007
- Study completionMay 2007
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-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Investigators
- Samuel A Jacobs, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177554
- Sponsor's protocol ID
- UPCI #03-005
- Status last verified
- May 2008
- First submitted
- 13 Sep 2005
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jacobs SA, Swerdlow SH, Kant J, Foon KA, Jankowitz R, Land SR, DeMonaco N, Joyce J, Osborn JL, Evans TL, Schaefer PM, Luong TM. Phase II trial of short-course CHOP-R followed by 90Y-ibritumomab tiuxetan and extended rituximab in previously untreated follicular lymphoma. Clin Cancer Res. 2008 Nov 1;14(21):7088-94. doi: 10.1158/1078-0432.CCR-08-0529.
PubMed 18981007
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT00177554
- Acronym / sponsor ID
- UPCI #03-005
- Conditions
- Non-Hodgkin Lymphoma
- Keywords
- Non-Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- Nov 2003
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 15 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.
The purpose of this study is to determine the complete response rate when CHOP-R chemotherapy in followed by Zevalin in previous untreated patients with follicular lymphoma
Detailed description
Patients with follicular lymphoma who require therapy and have been previously untreated are eligible for this non-randomized, phase II study evaluating up front therapy with CHOP-R x 3 cycles followed by zevalin and 4 additional weeks of rituxan.The complete response will be determined by combining IWC criteria and PET scanning.Secondary objectives include PET-CT conversion rate, frequency and severity of adverse events, duration of complete remission and time to next lymphoma therapy.
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 (5 listed)
- Conformed diagnosis of follicular lymphoma, grades 1,2 or 3
- No prior chemotherapy
- No prior monoclonal antibody therapy
- Bulky or symptomatic disease, stage II-IV
- Performance status 0-2
Key exclusion criteria (3 listed)
- Impaired bone marrow reserve
- Presence of CNS lymphoma
- Serious nonmalignant disease or active infection
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 and RadioimmunotherapyCHOP-R x 3 cycles followed by zevalin and extended rituximab | Drug | – |
Primary outcome
Complete response rate
Time frame: May 2007,May 2008, May2009, May 2010
4 secondary outcomes
PET-CT conversion rate
Time frame: May2007
Frequency and severity of adverse events
Time frame: May 2007
Duration of complete response
Time frame: May 2007,May 2008, May 2009, May 2010
Time to next lymphoma therapy
Time frame: May 2207,May2008,May2009, May2010
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 29 May 2008.
- Derived from this study: PubMed 18981007Jacobs SA, Swerdlow SH, Kant J, Foon KA, Jankowitz R, Land SR, DeMonaco N, Joyce J, Osborn JL, Evans TL, Schaefer PM, Luong TM. Phase II trial of short-course CHOP-R followed by 90Y-ibritumomab tiuxetan and extended rituximab in previously untreated follicular lymphoma. Clin Cancer Res. 2008 Nov 1;14(21):7088-94. doi: 10.1158/1078-0432.CCR-08-0529.
Related trials for Non-Hodgkin Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
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.
Samuel A Jacobs, MD principal investigator
University of Pittsburgh
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 and Radioimmunotherapy in people with Non-Hodgkin Lymphoma, run by University of Pittsburgh at 1 site in United States.
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 5 inclusion and 3 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 29 May 2008. 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 United States. 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?
Complete response rate (time frame: May 2007,May 2008, May2009, May 2010). 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 NCT00177554, 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 29 May 2008.