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DLBCLPhase 3NCT01285765

Evaluate a Treatment Adapted to the PET Response Compared to a Standard Treatment, for Low Risk DLBCL CD 20+ Patients

A Phase 3 study testing RCHOP21 in people with DLBCL, run by The Lymphoma Academic Research Organisation at 83 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

In this study, the investigators purpose is to evaluate the adaptation of treatment with early response based on PET scan results after 2 cycles of chemotherapy, for patient aged from 18 to 80 years, with low IPI DLBCL. This is an open randomized study. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
DLBCL
What is being tested?
RCHOP21
Could I receive a placebo?
No, everyone receives an active treatment
How many people
650 participants
Where
83 sitesin 2 countries
Study dates
Dec 2010to 23 May 2020
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma (Follicular, other...) may also be included; or CD20+ B-cell lymphoma with intermediate features between DLBCL and Burkitt; or with intermediate features between DLBCL and classical Hodgkin lymphoma; or CD20+ Follicular lymphoma grade 3B; or CD20+ Aggressive B-cell lymphoma unclassifiable.
  • Age from18 to 80 years.
  • Patient not previously treated.
  • Ann Arbor Stage : I or II.
  • Normal level of LDH.
  • ECOG performance status (PS) < 2.
Show all 10Show fewer
  • Age-adjusted international prognostic index (aaIPI) = 0.
  • Baseline PET (PET0) performed before any treatment, even in absence of known lesion (for stage I for which the lesion has been removed for diagnostic reason).
  • Having previously signed a written informed consent.
  • The subject must be covered by a social security system (in France).

Who cannot join

  • Any other histological type of lymphoma, Burkitt included.
  • Any history of treated or non-treated small B-cell lymphoma.
  • Central nervous system or meningeal involvement by lymphoma.
  • Contra-indication to any drug contained in the chemotherapy regimens.
  • Poor renal function (creatinin level >150 mmol/L), poor hepatic function (total bilirubin level >30 mmol/L, transaminases >2.5 ULN) unless these abnormalities are related to the lymphoma.
  • Poor bone marrow reserve as defined by Absolute Neutrophils Count (ANC) <1.5 G/L or platelets <100 G/L, unless related to bone marrow infiltration.
Show all 13Show fewer
  • Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
  • Any serious active disease (according to the investigator's decision).
  • Positive HIV, HBV and HCV serologies before inclusion (except after hepatitis B vaccination or for patients who are HBs Ag negative, anti-HBs positive and/or anti-HBc positive but viral DNA negative).
  • Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy.
  • Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception.
  • Adult patient under tutelage.
  • Impossibility to perform a baseline PET scan (PET0) before randomization and treatment start.

Trial locations and contacts

83 sites in 2 countries.

83 sites in 2 countries

France69 sites

  • CHU Angers

    Angers, 49033

  • Centre Hospitalier Victor Dupouy

    Argenteuil, 95107

  • CH d'ARRAS

    Arras, 62022

  • CH d'Avignon

    Avignon, 84902

  • CH de la Côte Basque

    Bayonne, 64100

  • CHU de Besançon - Hôpital Jean Minjoz

    Besançon, 25030

  • Institut Bergonié - Bordeaux

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • CH du Dr Duchenne

    Boulogne-sur-Mer, 62200

  • CH de Bourg-en-Bresse

    Bourg-en-Bresse, 01012

  • IHBN - CHU Côte de Nacre

    Caen, 14000

  • CH de Cannes

    Cannes, 06401

  • Médipôle de Savoie

    Challes-les-Eaux, 73190

  • Hôpital de Chalon

    Chalon-sur-Saône, 71100

  • CH de Chambéry

    Chambéry, 73000

  • Hôpital d'Instruction des Armées Percy

    Clamart, 92141

  • CHU Estaing - Clermont Ferrand

    Clermont-Ferrand, 63000

  • Hôpital Pasteur

    Colmar, 68024

  • CH de Compiègne

    Compiègne, 60321

  • Centre Hospitalier Alpes Léman

    Contamine-sur-Arve, 74130

  • CH Sud Francilien

    Corbeil-Essonnes, 91106

  • Hôpital Henri MONDOR

    Créteil, 94010

  • Chu Dijon

    Dijon, 21000

  • CH de Dunkerque

    Dunkirk, 59385

  • CHU de Grenoble - Hôpital Albert Michallon

    Grenoble, 38043

  • CH Départemental Vendée

    La Roche-sur-Yon, 85925

  • CH de Versailles

    Le Chesnay, 78157

  • CHU Bicetre

    Le Kremlin-Bicêtre, 94275

  • CH de Lens

    Lens, 62307

  • Hôpital Saint Vincent

    Lille, 59020

  • CHRU de Lille

    Lille, 59037

  • CHU de Limoges

    Limoges, 87042

  • Clinique Mutualiste Eugène André

    Lyon, 69003

  • Clinique de la Sauvegarde

    Lyon, 69009

  • Centre Léon Bérard

    Lyon, 69373

  • Hôpital des Chanaux

    Mâcon, 71108

  • Institut Paoli Calmettes

    Marseille, 13273

  • CH de Meaux

    Meaux, 77100

  • CH Marc Jacquet

    Melun, 77011

  • Hôpital Notre Dame du Bon Secours

    Metz, 57038

  • CH de Mulhouse

    Mulhouse, 68070

  • Centre d'Oncologie de Gentilly

    Nancy, 54000

  • Centre Antoine Lacassagne

    Nice, 06189

  • CHU de Nice

    Nice, 06202

  • Hôpital Saint Louis

    Paris, 75010

  • Hôpital Saint Antoine, Service d'hématologie du Pr Marie

    Paris, 75012

  • Hôpital Saint Antoine

    Paris, 75012

  • Institut Curie

    Paris, 75248

  • Hôpital de la Pitié Salpétrière

    Paris, 75651

  • Hôpital Necker

    Paris, 75743

  • Hôpital LYON SUD

    Pierre-Bénite, 69495

  • CHU de Poitiers

    Poitiers, 86021

  • CH Rene Dubos

    Pontoise, 95303

  • CH de la Région d'Annecy

    Pringy, 74370

  • CHU de Reims

    Reims, 51092

  • CHU de Rennes - Hôpital Pontchaillou

    Rennes, 35003

  • Centre Hospitalier de Roubaix

    Roubaix, 59100

  • Centre Henri Becquerel

    Rouen, 76000

  • CH de Saint-Brieuc - Hôpital Yves Le Foll

    Saint-Brieuc, 22023

  • Hôpital René Huguenin

    Saint-Cloud, 92210

  • Institut de cancérologie de la Loire

    Saint-Priest-en-Jarez, 42271

  • CHU de Strasbourg

    Strasbourg, 67098

  • Hôpitaux du Leman

    Thonon-les-Bains, 74203

  • Hôpital Sainte Musse

    Toulon, 83056

  • CHU de Tours - Hôpital Bretonneau

    Tours, 37044

  • CH de Troyes

    Troyes, 10003

  • CH de Valence

    Valence, 26953

  • CHU Brabois

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Belgium14 sites

  • ZNA Stuivenberg

    Antwerp, 2060

  • A. Z. Sint-Jan

    Bruges, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • Université Libre de Bruxelles - Hôpital Erasme

    Brussels, 1070

  • Université Catholique de Louvain Saint Luc

    Brussels, 1200

  • Grand Hôpital de Charleroi

    Charleroi, 6000

  • UZ Gent

    Ghent, 9000

  • Hôpital Jolimont

    Haine-Saint-Paul, 7100

  • CHU de Liège

    Liège, 4000

  • Clinique Saint Joseph

    Mons, 7000

  • Clinique Saint Pierre

    Ottignies, 1340

  • Centre Hospitalier de Wallonie Picarde - CHwapi

    Tournai, 7500

  • CH de la Tourelle-Peltzer

    Verviers, 4800

  • UCL Mont Godinne

    Yvoir, 5530

Other trials in Belgium

About this study

Official title: Randomized Phase III Study Evaluating the Non-inferiority of a Treatment Adapted to the Early Response Evaluated With 18F-FDG PET Compared to a Standard Treatment, for Patients Aged From 18 to 80 Years With Low Risk (aa IPI = 0) Diffuse Large B-cells Non Hodgkin's Lymphoma CD 20+

In this study, the investigators purpose is to evaluate the adaptation of treatment with early response based on PET scan results after 2 cycles of chemotherapy, for patient aged from 18 to 80 years, with low IPI DLBCL.

This is an open randomized study.

Read more

The primary endpoint is to evaluate the 3 years PFS with the aim to demonstrate the non inferiority of the experimental arm in comparison to standard arm:

In standard arm, the patients will receive 6 cycles of R-CHOP 21 without taking into account of PET scan results after 2 cycles.

In experimental arm, early good responder patients (defined as having a negative PET scan after 2 cycles, confirmed after 4 cycles) will receive only 4 cycles of R-CHOP 21.

In both arms, if the PET scan remains positive after 4 cycles of chemotherapy, a biopsy exam is needed to confirm the failure and an intensive chemotherapy is then recommended.

All of the patients, in both arms, will have an early evaluation with PET scan. All PET scan will be reviewed by a group of expert according to Deauville criteria defined by Meignan et al to adapt the decision after the 2nd cycle in experimental arm and after the 4th cycle for all patients. The final evaluation of response will be made according to 2007 Cheson's criteria.

Read the detailed description

Localized stages DLBCL with low IPI (aaIPI = 0) have a very good prognostic after a standard immuno-chemotherapy with 6 cycles of R-CHOP 21. Five years PFS is estimated over 75%, whatever the age of the patient.

PET scan is actually considered as "the gold standard" for the initial staging and the evaluation of response after treatment. With this new technique, the response criteria have been redefined by Cheson and al. in 2007. Moreover, several recent studies showed that early evaluation of response with PET scan after only 2 cycles of chemotherapy was accurate to define two groups of patients:

"Early-good-responders", when PET scan is negative "Early-poor-responders", when PET scan remains positive Prognostic for the first group is very good, and for the second poorer. At the present time, the interest of the modification and/or the intensification of the treatment for the early-poor-responder patients is not demonstrated by any publication. New studies are ongoing for patients with advanced stages of DLBC NHL (GELA trial LNH 07-3B) or Hodgkin's lymphoma (GELA and EORTC trial H10); the aim is to evaluate a new strategy of treatment adapted to early response criteria.

No trial has already been made for low IPI DLBCL. In this study, the investigators purpose is to evaluate the adaptation of treatment with early response based on PET scan results after 2 cycles of chemotherapy, for patient aged from 18 to 80 years, with low IPI DLBCL.

This is an open randomized study.

The primary endpoint is to evaluate the 3 years PFS with the aim to demonstrate the non inferiority of the experimental arm in comparison to standard arm:

In standard arm, the patients will receive 6 cycles of R-CHOP 21 without taking into account of PET scan results after 2 cycles.

In experimental arm, early good responder patients (defined as having a negative PET scan after 2 cycles, confirmed after 4 cycles) will receive only 4 cycles of R-CHOP 21.

In both arms, if the PET scan remains positive after 4 cycles of chemotherapy, a biopsy exam is needed to confirm the failure and an intensive chemotherapy is then recommended.

All of the patients, in both arms, will have an early evaluation with PET scan. All PET scan will be reviewed by a group of expert according to Deauville criteria defined by Meignan et al to adapt the decision after the 2nd cycle in experimental arm and after the 4th cycle for all patients. The final evaluation of response will be made according to 2007 Cheson's criteria.

Conditions
DLBCL
Being tested
RCHOP21

What participants receive

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

  • RCHOP21Drug

    Also called Rituximab-CHOP21

    Prednisone-60 mg/m2: D1 D2 D3 D4 D5;Rituximab-375 mg/m2 : D1; Doxorubicin-50 mg/m2 D1;Cyclophosphamide-750 mg/m2:D1 Vincristine-1.4 mg/m2 :D1; G-CSF SC -5 microg/kg/day: D6 to D13

Study groups in NCT01285765
Study groupRoleWhat they receive
Early-PET-result-adapted treatmentExperimental4 to 6 RCHOP21
Receives: Drug: RCHOP21
standard treatmentActive comparator6 RCHOP21
Receives: Drug: RCHOP21

What is being measured

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

  1. Progression Free Survival

    Evaluate by PFS at 3 years the non-inferiority of a chemotherapy treatment with 4 or 6 cycles of R-CHOP 21, determined according to early response assessed by PET at the end of 2 cycles versus standard chemotherapy of 6 cycles of R-CHOP 21 in patients with DLBCL lymphoma CD20+ with no factors of the IPI age adjusted.

    Measured: 3 years

Secondary outcomes (6)

  1. DELTA SUV

    Determine the decrease of SUV max between PET at baseline, PET after cycle 2 and PET after cycle 4 and evaluate the changes predictive interest.

    Measured: 3 weeks post C4 last patient

  2. Overall Survival, EFS, response duration, DFS

    Assess the overall survival, the EFS (Event Free Survival - events defined as death from any cause, relapse for complete responders and undocumented complete responders, progression during or after treatment, initiation of a new anti-lymphoma therapy), the response duration, and the DFS for complete responders (disease free survival).

    Measured: 3 years

  3. prognostic impact of the existence of a high tumor burden at diagnosis (> 10 cm) on PFS

    Evaluate the prognostic impact of the existence of a high tumor burden at diagnosis (> 10 cm).

    Measured: 3 years

  4. biological factors

    Identify the biological factors on blood samples and on tumor biopsy influencing the patient treatment response and prognosis.

    Measured: 3 weeks post last cycle and 3years survival

  5. Overall Response Rate

    Evaluate the overall response rate according to IWC (International Harmonization Project - Cheson 2007) (CR, PR) after 4 or 6 cycles of R-CHOP21 according to the treatment arm.

    Measured: 3 weeks post last cycle last patient

  6. Rate of good responders according to results at PET after C2

    Evaluate the rate of negative PET2

    Measured: 3 weeks post C2 last patient

Timeline

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

  1. First posted28 Jan 2011 (estimated)
  2. Study startDec 2010
  3. Primary completion23 May 2020
  4. Study completion23 May 2020

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
650 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01285765
Sponsor's protocol ID
LNH 2009-1B
Status last verified
Jul 2020
First submitted
14 Jan 2011
Last updated
14 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Michot JM, Bologna S, Bastie JN, Borght TV, Briere J, Ribrag V, Bommier C, Peyrade F, Lebras L, Damaj G, Coso D, Sibon D, Bonnet C, Morschhauser F, Ghesquieres H, Fruchart C, Soussain C, Becker S, Olivier P, Julian A, Molina T, Haioun C, Tilly H. Early positron emission tomography response-adapted treatment in low-risk diffuse large B-cell lymphoma: an open-label, multicenter, randomized, noninferiority phase III trial. Ann Oncol. 2026 Mar;37(3):403-413. doi: 10.1016/j.annonc.2025.11.006. Epub 2025 Nov 17.

    PubMed 41260259

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RCHOP21 in people with DLBCL, run by The Lymphoma Academic Research Organisation at 83 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 10 inclusion and 13 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 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 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 (time frame: 3 years). 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 NCT01285765, 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 14 Jul 2020.

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