LymphomaPhase 2NCT00690560
Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma
A Phase 2 study testing rituximab, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma, run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vincristine, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- rituximab, cyclophosphamide and doxorubicin hydrochloride
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- May 2007to Oct 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed large B-cell lymphoma
- Stage I, II, III, or IV disease
- Bone marrow or lymph node involvement by small cell lymphoma allowed
- No serious, progressive pathology (at investigator's discretion)
- CD20-positive disease
- Measurable disease
- No prior indolent lymphoma, treated or not
- No meningeal or CNS lymphoma
PATIENT CHARACTERISTICS:
- International prognostic index < 2 (adjusted for age)
- Life expectancy > 3 months
- ALT and AST ≤ 2.5 times upper limit of normal
- Bilirubin ≤ 30 mmol/L
- Creatinine ≤ 150 μmol/L
- HIV, hepatitis B virus, and hepatitis C virus negative (unless after vaccine)
- No contraindication to chemotherapy or immunotherapy
- No cancer in the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- No contraindication to a venous catheter
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 30 days since prior and no other concurrent investigational treatment
- No prior therapy
- No concurrent participation in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: International Phase II Study Evaluating the Association of CHOP-rituximab With Consolidation by Early Ibritumomab Tiuxetan-Y90 in Patients Aged 65 to 80 Years With CD20+ Large Cell Malignant Lymphoma and no Prior Therapy
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vincristine, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Steroid therapy, such as prednisone, may be effective in treating cancer and blocking the body's immune response. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving chemotherapy together with prednisone and monoclonal antibody therapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving doxorubicin together with vincristine, cyclophosphamide, prednisone, and rituximab followed by rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with newly diagnosed large B-cell lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine event-free survival of patients with large B-cell lymphoma treated with CHOP-R followed by consolidation therapy.
Secondary
- Determine overall survival.
- Evaluate relapse-free survival for patients achieving complete or partial response.
- Determine the rate of disease progression.
- Determine response rate at the end of study therapy.
- Assess the toxicities of this regimen.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive the CHOP-R regimen comprising doxorubicin hydrochloride IV, vincristine IV, cyclophosphamide IV, and rituximab IV on day 1 and prednisone IV on days 1-5. Treatment repeats every 2 weeks for 2 courses.
Patients who achieve complete or partial response, as assessed by PET/CT scan, receive a third course of induction therapy.
- Consolidation therapy: Patients receive rituximab IV on days -8 to 0 and yttrium Y 90 ibritumomab tiuxetan IV on day 0.
- Conditions
- Lymphoma
- Being tested
- rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, vincristine sulfate
- Keywords
- contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
cyclophosphamideDrug
prednisoneDrug
yttrium Y 90 ibritumomab tiuxetanRadiation
| Study group | Role | What they receive |
|---|---|---|
| R-CHOP14 chemotherapy | Experimental | Not described Receives: Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisone; Drug: vincristine sulfate; Radiation: yttrium Y 90 ibritumomab tiuxetan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free Survival
Measured: 2 years
Secondary outcomes (3)
Overall Survival
Measured: 2 years
Relapse-free Survival in Responding Patients
Measured: 2 years
Response Rate at the End of Treatment
Complete Response 60% (N=15) Partial Response 8% (N=2) Missing data 32% (N=8)
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startMay 2007
- Primary completionMar 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederec Peyrade, MD, Study chair, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690560
- Sponsor's protocol ID
- 2006/27
- Other IDs
- CALACASS-3RCHOPZ, INCA-RECF0624, 2006-006179-19, CALACASS-2006/27
- Status last verified
- Apr 2026
- First submitted
- 3 Jun 2008
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Phase II Study Evaluating the Association of CHOP-rituximab With Consolidation by Early Ibritumomab Tiuxetan-Y90 in Patients Aged 65 to 80 Years With CD20+ Large Cell Malignant Lymphoma and no Prior Therapy
- ClinicalTrials.gov ID
- NCT00690560
- Acronym / sponsor ID
- 2006/27
- Conditions
- Lymphoma
- Keywords
- contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 4 Jun 2008 (estimated)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vincristine, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Steroid therapy, such as prednisone, may be effective in treating cancer and blocking the body's immune response. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving chemotherapy together with prednisone and monoclonal antibody therapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving doxorubicin together with vincristine, cyclophosphamide, prednisone, and rituximab followed by rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with newly diagnosed large B-cell lymphoma.
Detailed description
OBJECTIVES:
Primary
- Determine event-free survival of patients with large B-cell lymphoma treated with CHOP-R followed by consolidation therapy.
Secondary
- Determine overall survival.
- Evaluate relapse-free survival for patients achieving complete or partial response.
- Determine the rate of disease progression.
- Determine response rate at the end of study therapy.
- Assess the toxicities of this regimen.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive the CHOP-R regimen comprising doxorubicin hydrochloride IV, vincristine IV, cyclophosphamide IV, and rituximab IV on day 1 and prednisone IV on days 1-5. Treatment repeats every 2 weeks for 2 courses.
Patients who achieve complete or partial response, as assessed by PET/CT scan, receive a third course of induction therapy.
- Consolidation therapy: Patients receive rituximab IV on days -8 to 0 and yttrium Y 90 ibritumomab tiuxetan IV on day 0.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-CHOP14 chemotherapy | Experimental | Biological: rituximab, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: prednisone, Drug: vincristine sulfate, Radiation: yttrium Y 90 ibritumomab tiuxetan |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 | Biological | R-CHOP14 chemotherapy |
| cyclophosphamide | Drug | R-CHOP14 chemotherapy |
| doxorubicin hydrochloride | Drug | R-CHOP14 chemotherapy |
| prednisone | Drug | R-CHOP14 chemotherapy |
| vincristine sulfate | Drug | R-CHOP14 chemotherapy |
| yttrium Y 90 ibritumomab tiuxetan | Radiation | R-CHOP14 chemotherapy |
Primary outcome
Event-free Survival
Time frame: 2 years
3 secondary outcomes
Overall Survival
Time frame: 2 years
Relapse-free Survival in Responding Patients
Time frame: 2 years
Response Rate at the End of Treatment
Time frame: up to six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Frederec Peyrade, MD study chair
Centre Antoine Lacassagne
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 rituximab, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma, run by Centre Antoine Lacassagne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 May 2026. 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 France. 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?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Event-free Survival (time frame: 2 years). 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 22 May 2026.