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B Cell LymphomaPhase 3NCT00841945

Treatment of Aggressive Localized Lymphoma

A Phase 3 study testing rituximab, doxorubicin and vincristine in people with B Cell Lymphoma, run by French Innovative Leukemia Organisation at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Prospective and multicentric Phase III study, evaluation of the interest of the radiotherapy after 4 or 6 cycles of CHOP 14 R regimen of chemotherapy , patients with agressive and localized B lymphoma , age 18 to 75 years. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
B Cell Lymphoma
What is being tested?
rituximab, doxorubicin and vincristine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
334 participants
Where
1 siteFrance
Study dates
Apr 2005to Feb 2017
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 18 and < 75 years
  • Diffuse B large cell lymphoma , CD 20+
  • Ann Arbor stage I or II withe a bulk <7 cm
  • stage i ou II confirmed by the PET-scan
  • No previously treated
  • HIV negative
  • Signed Informed consent

Who cannot join

  • Age< 18 and > 75 years
  • other type of lymphoma
  • CD20 negative
  • Ann Arbor stage >II or bulk > 7 cm
  • HIV positive
  • Contraindication to Rituximab use according to Sm PC
Show all 9Show fewer
  • Containdication to antracyclin
  • cancer or history of cancer , excepted in situ cancer of the cervix or skin epithelioma
  • Refusal of sign the informed consent

Trial locations and contacts

1 site in 1 country.

France1 site

  • Regional university hospital

    Rennes, 35033

Other trials in France

About this study

Official title: Phase III Study of the Interest of Radiotherapy After 4 or 6 Cycles of CHOP 14 Rituximab Regimen of Chemotherapy , Patients With Agressive Localized Lymphoma

Prospective and multicentric Phase III study, evaluation of the interest of the radiotherapy after 4 or 6 cycles of CHOP 14 R regimen of chemotherapy , patients with agressive and localized B lymphoma , age 18 to 75 years.

Read the detailed description

CHOP 14 R regimen of chemotherapy is a good standard in the treatment of agressive and localized B lymphoma.

Interest of the radiotheraphy

Conditions
B Cell Lymphoma
Being tested
rituximab, doxorubicin, vincristine, prednisone, radiotherapy
Keywords
Diffuse B larg cell lymphoma, Chemotherapy, Radiotherapy
Medical subject headings
Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rituximabDrug

    Also called MABTHERA

    RITUXIMAB 375 MG/M² IV DAY 1 or each course

  • doxorubicinDrug

    Also called Adriblastine

    doxorubicin 50 mg / m² iv day 1 of each course

  • vincristineDrug

    Also called Oncovin

    VINCRISTINE 1?4 MG/M² IV ON DAY 1

  • prednisoneDrug

    Also called solupred

    Prednisone 40 mg/m² DAy 1 to day 5

  • radiotherapyProcedure or surgery

    Also called no other name

    radiotherapy : total dose = 40 GY (5 fractions by week)

Study groups in NCT00841945
Study groupRoleWhat they receive
1Active comparatorChemotherapy + Radiotherapy - 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone * Radiotherapy 40 gray on initial nodes
Receives: Drug: rituximab; Drug: doxorubicin; Drug: vincristine; Drug: prednisone; Procedure: radiotherapy
2ExperimentalChemotherapy - 4 or 6 R CHOP courses regimen every 14 days R CHOP = Rituximab, Doxorubicin, Vincristine and prednisone
Receives: Drug: rituximab; Drug: doxorubicin; Drug: vincristine; Drug: prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event Free Survival (EFS) and Progression Free Survival (PFS)

    Measured: EFS PFS one year after treatment

Secondary outcomes (2)

  1. Pet-scan

    Measured: pronostic impact of Pet-scan

  2. radiotherapy

    Measured: Toxicity of the radiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2009 (estimated)
  2. Study startApr 2005
  3. Primary completionJan 2016
  4. Study completionFeb 2017

Why it stopped: other drugs other studies

Resources

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
334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00841945
Sponsor's protocol ID
GOELAMS 02 03
Status last verified
Feb 2017
First submitted
11 Feb 2009
Last updated
23 Feb 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Lamy T, Damaj G, Soubeyran P, Gyan E, Cartron G, Bouabdallah K, Gressin R, Cornillon J, Banos A, Le Du K, Benchalal M, Moles MP, Le Gouill S, Fleury J, Godmer P, Maisonneuve H, Deconinck E, Houot R, Laribi K, Marolleau JP, Tournilhac O, Branger B, Devillers A, Vuillez JP, Fest T, Colombat P, Costes V, Szablewski V, Bene MC, Delwail V; LYSA Group. R-CHOP 14 with or without radiotherapy in nonbulky limited-stage diffuse large B-cell lymphoma. Blood. 2018 Jan 11;131(2):174-181. doi: 10.1182/blood-2017-07-793984. Epub 2017 Oct 23.

    PubMed 29061568

  • Tout M, Casasnovas O, Meignan M, Lamy T, Morschhauser F, Salles G, Gyan E, Haioun C, Mercier M, Feugier P, Boussetta S, Paintaud G, Ternant D, Cartron G. Rituximab exposure is influenced by baseline metabolic tumor volume and predicts outcome of DLBCL patients: a Lymphoma Study Association report. Blood. 2017 May 11;129(19):2616-2623. doi: 10.1182/blood-2016-10-744292. Epub 2017 Mar 1.

    PubMed 28251914

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rituximab, doxorubicin and vincristine in people with B Cell Lymphoma, run by French Innovative Leukemia Organisation 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?

The sponsor lists 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 23 Feb 2017. 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 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 was stopped early (reason given: other drugs other studies). Results are not available in the source record.

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 (EFS) and Progression Free Survival (PFS) (time frame: EFS PFS one year after treatment). 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 NCT00841945, which also lists 2 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 23 Feb 2017.

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