Follicular LymphomaPhase 3NCT00140569
Randomized Study for Patients With Follicular Lymphoma Needing Treatment
A Phase 3 study testing CHVP + interferon, fludarabine and CHOP + TBI and autotransplant in people with Follicular Lymphoma, run by Lymphoma Study Association at 8 sites in 2 countries.
Trial summary
2 parallel studies. For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI For elderly patients (>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- CHVP + interferon, fludarabine and CHOP + TBI and autotransplant
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jan 1994to Jan 2004
- Phase
- Phase 3
- 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
- study 1 (young patients): being less than 61 years old with a follicular lymphoma and needing to be treated because of high LDH level, high beta-2 microglobulin level, poor performance status, or large tumoral mass (lymph node >7 cm, symptomatic splenomegaly, pleura effusion, or sign of compression by the tumor mass)
- study 2 (elderly patients): being older than 60 years with a follicular lymphoma and needing to be treated because of high LDH level, high beta-2 microglobulin level, poor performance status, or large tumoral mass (lymph node >7 cm, symptomatic splenomegaly, pleura effusion, or sign of compression by the tumor mass)
Who cannot join
- contra-indication to anthracycline or interferon
- transformation into large cell lymphoma
- previous treatment
- localized stage without criteria of large tumor mass
- patients HIV+
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
France7 sites
Hôpital Henri Mondor
Créteil, 94010
Centre Léon Bérard
Lyon, 69008
Hôpital Saint Louis
Paris, 75010
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69495
Centre Hospitalier Robert Debré
Reims, 51092
Centre Henri Becquerel
Rouen, 76038
Institut Gustave Roussy
Villejuif
About this study
2 parallel studies.
- For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI
- For elderly patients (>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months
Read the detailed description
2 parallel studies.
- For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI
- For elderly patients (>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months
- Conditions
- Follicular Lymphoma
- Being tested
- CHVP + interferon, fludarabine, CHOP + TBI and autotransplant
- Keywords
- follicular lymphoma, CHVP + interferon, fludarabine, autotransplant
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHVP + interferonProcedure or surgery
fludarabineDrug
CHOP + TBI and autotransplantProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Secondary outcomes (3)
Overall survival
Toxicity
Response rates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startJan 1994
- Study completionJan 2004
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 Follicular 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Lymphoma Study Association
- Sponsor type
- University, hospital or other
- Investigators
- Bertrand Coiffier, MD, Study chair, Hospices Civils de LyonCatherine Sebban, MD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140569
- Sponsor's protocol ID
- Gelf-94
- Status last verified
- Aug 2005
- First submitted
- 31 Aug 2005
- Last updated
- 1 Sep 2005
- Results posted
- No
Publications
Coiffier B, Neidhardt-Berard EM, Tilly H, Belanger C, Bouabdallah R, Haioun C, Brice P, Peaud PY, Pico JL, Janvier M, Solal-Celigny P, Brousse N. Fludarabine alone compared to CHVP plus interferon in elderly patients with follicular lymphoma and adverse prognostic parameters: a GELA study. Groupe d'Etudes des Lymphomes de l'Adulte. Ann Oncol. 1999 Oct;10(10):1191-7. doi: 10.1023/a:1008347425795.
PubMed 10586336
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study for Patients With Follicular Lymphoma Needing Treatment
- ClinicalTrials.gov ID
- NCT00140569
- Acronym / sponsor ID
- Gelf-94
- Conditions
- Follicular Lymphoma
- Keywords
- follicular lymphoma, CHVP + interferon, fludarabine, autotransplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Lymphoma Study AssociationUniversity, hospital or other
- Study start
- Jan 1994
- Study completion
- Jan 2004
- First posted
- 1 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.
2 parallel studies.
- For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI
- For elderly patients (>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months
Detailed description
2 parallel studies.
- For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI
- For elderly patients (>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (2 listed)
- study 1 (young patients): being less than 61 years old with a follicular lymphoma and needing to be treated because of high LDH level, high beta-2 microglobulin level, poor performance status, or large tumoral mass (lymph node >7 cm, symptomatic splenomegaly, pleura effusion, or sign of compression by the tumor mass)
- study 2 (elderly patients): being older than 60 years with a follicular lymphoma and needing to be treated because of high LDH level, high beta-2 microglobulin level, poor performance status, or large tumoral mass (lymph node >7 cm, symptomatic splenomegaly, pleura effusion, or sign of compression by the tumor mass)
Key exclusion criteria (5 listed)
- contra-indication to anthracycline or interferon
- transformation into large cell lymphoma
- previous treatment
- localized stage without criteria of large tumor mass
- patients HIV+
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 |
|---|---|---|
| CHVP + interferon | Procedure or surgery | – |
| fludarabine | Drug | – |
| CHOP + TBI and autotransplant | Procedure or surgery | – |
Primary outcome
Progression-free survival
3 secondary outcomes
Overall survival
Toxicity
Response rates
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 1 Sep 2005.
- Results publication: PubMed 10586336Coiffier B, Neidhardt-Berard EM, Tilly H, Belanger C, Bouabdallah R, Haioun C, Brice P, Peaud PY, Pico JL, Janvier M, Solal-Celigny P, Brousse N. Fludarabine alone compared to CHVP plus interferon in elderly patients with follicular lymphoma and adverse prognostic parameters: a GELA study. Groupe d'Etudes des Lymphomes de l'Adulte. Ann Oncol. 1999 Oct;10(10):1191-7. doi: 10.1023/a:1008347425795.
- Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In french)Link provided by the sponsor.
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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.
Bertrand Coiffier, MD study chair
Hospices Civils de Lyon
Catherine Sebban, MD principal investigator
Centre Leon Berard
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CHVP + interferon, fludarabine and CHOP + TBI and autotransplant in people with Follicular Lymphoma, run by Lymphoma Study Association at 8 sites in 2 countries.
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 2 inclusion and 5 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 1 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Belgium. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Progression-free survival. 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 NCT00140569, 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 1 Sep 2005.