Untreated T-cell Angioimmunoblastic LymphomaPhase 2NCT00169156
A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma
A Phase 2 study testing Rituximab, Prednisone and Doxorubicine in people with Untreated T-cell Angioimmunoblastic Lymphoma, run by Lymphoma Study Association at 4 sites in France.
Trial summary
To evaluate the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Untreated T-cell Angioimmunoblastic Lymphoma
- What is being tested?
- Rituximab, Prednisone and Doxorubicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesFrance
- Study dates
- Dec 2005to Nov 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
- Patients with histologically proven T-cell angioimmunoblastic lymphoma (AIL) on lymph node biopsy.
- Aged from 60 to 80 years.
- Patient not previously treated (except corticosteroids providing they have been initiated less than 10 days before inclusion).
- ECOG performance status 0 to 2.
- With a minimum of life expectancy > 3 months.
- Negative HIV, HBV and HCV serological tests < 4 weeks (except after vaccination).
- Having previously signed a written informed consent.
Who cannot join
- Any other histological type of T-cell lymphoma.
- Central nervous system or meningeal involvement by lymphoma.
- Contra-indication to any drug included in the R-CHOP regimen.
- Concurrent severe disease (according to the investigator's decision).
- Active bacterial, viral or fungal infection.
- Poor renal function (serum creatinine level > 150 µmol/L) or impaired liver function tests (total bilirubin level > 30 µmol/L, transaminases > 2.5 upper normal limits) unless they are related to the lymphoma.
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- Poor bone marrow reserve as defined by neutrophils < 1.5 x 109/L or platelets < 100 x 109/L, unless related to bone marrow infiltration.
- Any history of cancer during the last 5 years, with the exception of non basal cell carcinoma of the skin or in situ carcinoma of the cervix.
- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
- Patient under tutelage.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital Henri Mondor
Créteil
Hôpital Saint Louis
Paris
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69495
Centre Henri Becquerel
Rouen
About this study
Official title: Study of the Efficacy and the Safety of First Line Treatment With CHOP Plus Rituximab (R-CHOP) in Patients Aged 60 to 80 Years With Previously Untreated T-cell Angioimmunoblastic Lymphoma (AIL).
To evaluate the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.
Read the detailed description
This is a multicentric, open-label, non-randomized clinical study, evaluating the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.
It is anticipated that 25 subjects will be enrolled over 2 years (from 2005 / 2007).Analysis performed every 5 patients (based on triangular test).
The duration of the treatment period is approximately 25 weeks and patients are followed until Death.
The total Duration of the study is expected to be 2.5 years.
- Being tested
- Rituximab, Prednisone, Doxorubicine, Cyclophosphamide, Vincristine
- Keywords
- T-cell angioimmunoblastic lymphoma, Rituximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
375 mg/m2 D1
PrednisoneDrug
40 mg/m2 D1 to D5
DoxorubicineDrug
50 mg/m2 D1
CyclophosphamideDrug
750 mg/m2 D1
VincristineDrug
1,4 mg/m2 D1
| Study group | Role | What they receive |
|---|---|---|
| Rituximab + CHOP | Experimental | Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine Receives: Drug: Rituximab; Drug: Prednisone; Drug: Doxorubicine; Drug: Cyclophosphamide; Drug: Vincristine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
[Complete response (CR), Complete response unconfirmed (CRu)] after the end of treatment.
Measured: 8 months (4 cycles of treatment + 4 cycles of consolidation)
Secondary outcomes (5)
Event-free survival (EFS) relapse for complete responders, disease progression, early discontinuation of treatment for toxicity or modification of treatment.
Events being death from any cause
Measured: 2 years
Overall survival (OS)
Measured: 2 years
Time to progression (TTF)
Measured: 2 years
Disease-free survival (DFS).
Measured: 2 years
number of SAE
Measured: 2 years
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 startDec 2005
- Primary completionDec 2008
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Untreated T-cell Angioimmunoblastic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lymphoma Study Association
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Corinne Haioun, MD, Study chair, Hôpital Henri Mondor, Créteil, FranceBertrand Joly, MD, Principal investigator, C.H. Sud Francilien, Corbeil-Essonnes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169156
- Sponsor's protocol ID
- RAIL
- Other IDs
- 2005-002602-37, 2005
- Status last verified
- Mar 2017
- First submitted
- 12 Sep 2005
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Attygalle A, Al-Jehani R, Diss TC, Munson P, Liu H, Du MQ, Isaacson PG, Dogan A. Neoplastic T cells in angioimmunoblastic T-cell lymphoma express CD10. Blood. 2002 Jan 15;99(2):627-33. doi: 10.1182/blood.v99.2.627.
PubMed 11781247Lome-Maldonado C, Canioni D, Hermine O, Delabesse E, Damotte D, Raffoux E, Gaulard P, Macintyre E, Brousse N; French Groupe d'Etude des Lymphomes de l'Adulte (GELA). Angio-immunoblastic T cell lymphoma (AILD-TL) rich in large B cells and associated with Epstein-Barr virus infection. A different subtype of AILD-TL? Leukemia. 2002 Oct;16(10):2134-41. doi: 10.1038/sj.leu.2402642.
PubMed 12357368Zettl A, Lee SS, Rudiger T, Starostik P, Marino M, Kirchner T, Ott M, Muller-Hermelink HK, Ott G. Epstein-Barr virus-associated B-cell lymphoproliferative disorders in angloimmunoblastic T-cell lymphoma and peripheral T-cell lymphoma, unspecified. Am J Clin Pathol. 2002 Mar;117(3):368-79. doi: 10.1309/6UTX-GVC0-12ND-JJEU.
PubMed 11888076Gisselbrecht C, Gaulard P, Lepage E, Coiffier B, Briere J, Haioun C, Cazals-Hatem D, Bosly A, Xerri L, Tilly H, Berger F, Bouhabdallah R, Diebold J. Prognostic significance of T-cell phenotype in aggressive non-Hodgkin's lymphomas. Groupe d'Etudes des Lymphomes de l'Adulte (GELA). Blood. 1998 Jul 1;92(1):76-82.
PubMed 9639502
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy and the Safety of First Line Treatment With CHOP Plus Rituximab (R-CHOP) in Patients Aged 60 to 80 Years With Previously Untreated T-cell Angioimmunoblastic Lymphoma (AIL).
- ClinicalTrials.gov ID
- NCT00169156
- Acronym / sponsor ID
- RAIL
- Keywords
- T-cell angioimmunoblastic lymphoma, Rituximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Lymphoma Study AssociationUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Dec 2005 (actual)
- Primary completion
- Dec 2008 (actual)
- Study completion
- Nov 2012 (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.
To evaluate the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.
Detailed description
This is a multicentric, open-label, non-randomized clinical study, evaluating the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.
It is anticipated that 25 subjects will be enrolled over 2 years (from 2005 / 2007).Analysis performed every 5 patients (based on triangular test).
The duration of the treatment period is approximately 25 weeks and patients are followed until Death.
The total Duration of the study is expected to be 2.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab + CHOP | Experimental | Drug: Rituximab, Drug: Prednisone, Drug: Doxorubicine, Drug: Cyclophosphamide, Drug: VincristineRituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with histologically proven T-cell angioimmunoblastic lymphoma (AIL) on lymph node biopsy.
- Aged from 60 to 80 years.
- Patient not previously treated (except corticosteroids providing they have been initiated less than 10 days before inclusion).
- ECOG performance status 0 to 2.
- With a minimum of life expectancy > 3 months.
Key exclusion criteria (10 listed)
- Any other histological type of T-cell lymphoma.
- Central nervous system or meningeal involvement by lymphoma.
- Contra-indication to any drug included in the R-CHOP regimen.
- Concurrent severe disease (according to the investigator's decision).
- Active bacterial, viral or fungal 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 |
|---|---|---|
| Rituximab375 mg/m2 D1 | Drug | Rituximab + CHOP |
| Prednisone40 mg/m2 D1 to D5 | Drug | Rituximab + CHOP |
| Doxorubicine50 mg/m2 D1 | Drug | Rituximab + CHOP |
| Cyclophosphamide750 mg/m2 D1 | Drug | Rituximab + CHOP |
| Vincristine1,4 mg/m2 D1 | Drug | Rituximab + CHOP |
Primary outcome
Overall Response Rate (ORR)
Time frame: 8 months (4 cycles of treatment + 4 cycles of consolidation)
[Complete response (CR), Complete response unconfirmed (CRu)] after the end of treatment.
5 secondary outcomes
Event-free survival (EFS) relapse for complete responders, disease progression, early discontinuation of treatment for toxicity or modification of treatment.
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Time to progression (TTF)
Time frame: 2 years
Disease-free survival (DFS).
Time frame: 2 years
number of SAE
Time frame: 2 years
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 13 Mar 2017.
- Background: PubMed 11781247Attygalle A, Al-Jehani R, Diss TC, Munson P, Liu H, Du MQ, Isaacson PG, Dogan A. Neoplastic T cells in angioimmunoblastic T-cell lymphoma express CD10. Blood. 2002 Jan 15;99(2):627-33. doi: 10.1182/blood.v99.2.627.
- Background: PubMed 12357368Lome-Maldonado C, Canioni D, Hermine O, Delabesse E, Damotte D, Raffoux E, Gaulard P, Macintyre E, Brousse N; French Groupe d'Etude des Lymphomes de l'Adulte (GELA). Angio-immunoblastic T cell lymphoma (AILD-TL) rich in large B cells and associated with Epstein-Barr virus infection. A different subtype of AILD-TL? Leukemia. 2002 Oct;16(10):2134-41. doi: 10.1038/sj.leu.2402642.
- Background: PubMed 11888076Zettl A, Lee SS, Rudiger T, Starostik P, Marino M, Kirchner T, Ott M, Muller-Hermelink HK, Ott G. Epstein-Barr virus-associated B-cell lymphoproliferative disorders in angloimmunoblastic T-cell lymphoma and peripheral T-cell lymphoma, unspecified. Am J Clin Pathol. 2002 Mar;117(3):368-79. doi: 10.1309/6UTX-GVC0-12ND-JJEU.
- Background: PubMed 9639502Gisselbrecht C, Gaulard P, Lepage E, Coiffier B, Briere J, Haioun C, Cazals-Hatem D, Bosly A, Xerri L, Tilly H, Berger F, Bouhabdallah R, Diebold J. Prognostic significance of T-cell phenotype in aggressive non-Hodgkin's lymphomas. Groupe d'Etudes des Lymphomes de l'Adulte (GELA). Blood. 1998 Jul 1;92(1):76-82.
- Official site of the Groupe d'Etude des Lymphomes de l'Adulte (In french)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Corinne Haioun, MD study chair
Hôpital Henri Mondor, Créteil, France
Bertrand Joly, MD principal investigator
C.H. Sud Francilien, Corbeil-Essonnes, France
4 sites 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, Prednisone and Doxorubicine in people with Untreated T-cell Angioimmunoblastic Lymphoma, run by Lymphoma Study Association at 4 sites in France.
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 7 inclusion and 10 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 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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 Response Rate (ORR) (time frame: 8 months (4 cycles of treatment + 4 cycles of consolidation)). 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 NCT00169156, which also lists 4 linked publications.
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 13 Mar 2017.