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Follicular LymphomaPhase 3FLIRTNCT02303119

Follicular Lymphoma IV/SC Rituximab Therapy (FLIRT)

A Phase 3 study testing Rituximab IV and Rituximab SC in people with Follicular Lymphoma, run by The Lymphoma Academic Research Organisation at 50 sites in France.

Completed

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

Official record
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Trial summary

Patient will receive either one infusion of rituximab IV and seven administrations of rituximab SC (experimental arm) or four infusions of rituximab IV (standard arm). The hypothesis is that the use of rituximab by sub cutaneous route and the scheme of administration could: optimize rituximab exposure leading to… 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?
Rituximab IV and Rituximab SC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
221 participants
Where
50 sitesFrance
Study dates
2 Feb 2015to 29 Jun 2021
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

  • Histologically confirmed follicular lymphoma CD20+ grade 1, 2 and 3a by biopsy within 4 months before signing informed consent
  • Have a bone marrow biopsy within 4 months before the first study drug administration
  • Have no prior therapy except surgery for diagnosis
  • Aged 18 years or more with no upper age limit
  • ECOG performance status 0-2
  • Ann Arbor Stage II, III or IV
Show all 19Show fewer
  • Bi-dimensionally measurable disease defined by at least one single node or tumor lesion > 1.5 cm assessed by CT scan and/or clinical examination
  • With low-tumor burden defined as:
  • Nodal or extra-nodal tumor mass with diameter less than 7 cm in its greater diameter
  • And involvement of less than 3 nodal or extra nodal sites with diameter greater than 3 cm
  • And absence of B symptoms
  • And no symptomatic splenomegaly
  • And no compression syndrome (ureteral, orbital, gastrointestinal…)
  • And no pleural or peritoneal serous effusion
  • And no cytopenia, with hemoglobin > 10 g/dL (6.25mmol/L) and absolute neutrophil count> 1.5 G/L and platelets > 100 G/L within 28 days before the randomization
  • And LDH < ULN within 28 days before the randomization
  • And β2 microglobulin < ULN within 28 days before the randomization
  • Have signed an informed consent
  • Must be covered by a social security system

Who cannot join

  • Grade 3b follicular lymphoma
  • Ann Arbor Stage I
  • Seropositive for or active viral infection with hepatitis B virus (HBV) HBs Ag positive HBs Ag negative, anti-HBs antibody positive and/or anti-HBc antibody positive and detectable viral DNA
  • Note:
  • Patients who are HBs Ag negative, anti-HBs positive and/or anti-HBc positive but viral DNA negative are eligible Patients who are seropositive due to a history of hepatitis B vaccine are eligible
  • Known seropositive for, or active viral infection with hepatitis C virus (HCV)
Show all 19Show fewer
  • Known seropositive for, or active viral infection with Human Immunodeficiency Virus (HIV)
  • Any of the following laboratory abnormalities within 28 days before the randomization:
  • Total bilirubin or GGT or AST or ALT > 3 ULN. Calculated creatinine clearance (Cockcroft and Gault formula) < 60 mL /min
  • Presence or history of CNS involvement by lymphoma
  • Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 3 years
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Patient with mental deficiency preventing proper understanding of the informed consent and the requirements of treatment.
  • Adult under law-control
  • Adult under tutelage
  • Contraindication to use rituximab or known sensitivity or allergy to murine products
  • Pregnant or lactating females.
  • Concomitant disease requiring prolonged use of corticosteroids or corticosteroids administration for lymphoma within 28 days before the first study drug administration.
  • Male and female patients of childbearing potential who cannot or do not wish to use an effective method of contraception, during the study treatment and for 12 months thereafter.

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

France50 sites

  • CH de Pays d'Aix

    Aix-en-Provence, 13606

  • CHU Angers

    Angers, 49933

  • CH d'Avignon - Hôpital Henri Duffaut

    Avignon, 84902

  • Hôpital de Bayonnes

    Bayonne, 64100

  • CH de BLOIS

    Blois, 41016

  • Hôpital d'Avicenne

    Bobigny, 93009

  • Institut Bergonié

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • IHBN - CHU de Caen

    Caen, 14033

  • Clinique du Parc

    Castelnau-le-Lez, 34170

  • CH de Chambéry

    Chambéry, 73011

  • Chu Estaing

    Clermont-Ferrand, 63003

  • Hôpital Pasteur

    Colmar, 68024

  • Hôpital Henri Mondor

    Créteil, 94010

  • CHU Dijon - Hôpital d'Enfants

    Dijon, 21000

  • Hôpital Albert Michallon

    Grenoble, 38043

  • CH Départemental Vendée

    La Roche-sur-Yon, 85925

  • Hôpital St Louis

    La Rochelle, 17019

  • Hôpital André Mignot

    Le Chesnay, 78157

  • Clinique Victor Hugo

    Le Mans, 72015

  • CHRU de Lille - Hôpital Claude Hurriez

    Lille, 59037

  • Centre Léon Bérard

    Lyon, 69373

  • Hôpital de la Conception

    Marseille, 13385

  • Hôpital Mercy

    Metz, 57085

  • Hôpital Saint-Eloi

    Montpellier, 34295

  • Hôpital Emile Muller

    Mulhouse, 68070

  • CHU de Nantes - Hôtel Dieu

    Nantes, 44093

  • Institut de Cancérologie du Gard Hématologie clinique

    Nîmes, 30029

  • CHR de la Source

    Orléans, 45067

  • Hôpital Cochin

    Paris, 75679

  • Hôpital Necker

    Paris, 75743

  • Hôpital Saint Jean

    Perpignan, 66046

  • Hôpital Haut Lévêque - Centre François Magendie

    Pessac, 33604

  • CHU Lyon Sud

    Pierre-Bénite, 69310

  • CH René Dubos

    Pontoise, 95300

  • Centre Hospitalier Annecy-Genevois

    Pringy, 74374

  • Hôpital Robert Debré

    Reims, 51092

  • Hôpital Pontchaillou

    Rennes, 35033

  • Hôpital Victor Provo

    Roubaix, 59100

  • Centre Henri Becquerel

    Rouen, 76038

  • Hôpital Yves Le Foll

    Saint-Brieuc, 20000

  • Institut de Cancérologie de l'Ouest René Gauducheau

    Saint-Herblain, 44805

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez, 42271

  • Hôpital de Hautepierre

    Strasbourg, 67098

  • IUCT Oncopole

    Toulouse, 31059

  • Hôpital Bretonneau

    Tours, 37044

  • CH de TROYES

    Troyes, 10003

  • CH de Valenciennes

    Valenciennes, 59322

  • CHU Nancy - Hôpital de Brabois

    Vandœuvre-lès-Nancy, 54500

  • CH Bretagne Atlantique

    Vannes, 56017

Other trials in France

About this study

Official title: A Randomized Phase III Trial Evaluating Two Strategies of Rituximab Administration for the Treatment of First Line/Low Tumor Burden Follicular Lymphoma (Follicular Lymphoma IV/SC Rituximab Therapy)

Patient will receive either one infusion of rituximab IV and seven administrations of rituximab SC (experimental arm) or four infusions of rituximab IV (standard arm).

The hypothesis is that the use of rituximab by sub cutaneous route and the scheme of administration could:

  • optimize rituximab exposure leading to improve response rate
  • increase adaptative response and then improve long-term control disease.
Being tested
Rituximab IV, Rituximab SC
Keywords
LNH, CD20+, follicular
Medical subject headings
Lymphoma, Follicular

What participants receive

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

  • Rituximab IVDrug

    Also called MabThera IV

    intra-venous, 375 mg/m²

  • Rituximab SCDrug

    Also called MabThera SC

    sub-cutaneous, 1400 mg

Study groups in NCT02303119
Study groupRoleWhat they receive
Am A : Rituximab IVActive comparator4 infusions of intravenous rituximab (375mg/m²) at Day 1, Day 8, Day 15 and D22
Receives: Drug: Rituximab IV
Arm B: Rituximab SCExperimental1 infusion of intravenous rituximab (375mg/m²) at Day 1, and 7 administrations of sub-cutaneous rituximab (1400mg) at Day 8, Day15, Day 22, Month 3, Month 5, Month 7 and Month 9.
Receives: Drug: Rituximab IV; Drug: Rituximab SC
Arm C : Rituximab SC first cycleExperimental8 administrations of sub-cutaneous rituximab (1400mg) at Day 8, Day15, Day 22, Month 3, Month 5, Month 7 and Month 9.
Receives: Drug: Rituximab SC

What is being measured

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

  1. Progression Free Survival (PFS)

    Time from randomization into the study to the first observation of documented disease progression or death due to any cause. If a subject has not progressed or died, PFS will be censored at the time of last visit with adequate assessment

    Measured: 5.5 years

Secondary outcomes (5)

  1. Overall Survival (OS)

    time from the date of randomization to the date of death from any cause. Alive patients will be censored at their last follow-up date.

    Measured: 5.5 years

  2. Response Rates

    Disease response evaluation, assessment will be based on the International Workshop to Standardize Response criteria for NHL (Criteria for evaluation of response in Non-Hodgkin's lymphoma) according to Cheson 1999 (M3 and M12) and according to Cheson 2014 (M12 only).

    The response rates will be described for each modality (CR, CRu, PR, SD and PD) and the Overall response rates (CR+CRu+PR) will also be described at the two time points (M3 \& M12).

    Measured: M3 and M12

  3. Best Response Rate during the study

    Best disease response, assessment of response will be based on the International Workshop to Standardize Response criteria for NHL (Criteria for evaluation of response in Non-Hodgkin's lymphoma (Cheson, 1999)).

    The response rates will be described for each modality (CR, CRu, PR, SD and PD) and the Overall response rates (CR+CRu+PR) will also be described

    Measured: M3 and M12

  4. Time to Next Anti-Lymphoma Treatment (TTNLT)

    time from randomization to the date of first documented administration of any new anti-lymphoma treatment (chemotherapy, radiotherapy, radio-immunotherapy, immunotherapy…). Patients continuing in response or who are lost to follow-up will be censored on their last visit date. Patients who died (due to any cause) before having received a new anti-lymphoma treatment will be included in the statistical analysis with death being counted as an event.

    Measured: 5.5 years

  5. Molecular Response

    Bcl-2-IgH rearrangement

    Measured: M3 and M12

Timeline

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

  1. First posted27 Nov 2014 (estimated)
  2. Study start2 Feb 2015
  3. Primary completion29 Jun 2021
  4. Study completion29 Jun 2021

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
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02303119
Sponsor's protocol ID
FLIRT
Acronym
FLIRT
Status last verified
Jan 2023
First submitted
25 Nov 2014
Last updated
10 Jan 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Cartron G, Bachy E, Tilly H, Daguindau N, Pica GM, Bijou F, Mounier C, Clavert A, Damaj GL, Slama B, Casasnovas O, Houot R, Bouabdallah K, Sibon D, Fitoussi O, Morineau N, Herbaux C, Gastinne T, Fornecker LM, Haioun C, Launay V, Araujo C, Benbrahim O, Sanhes L, Gressin R, Gonzalez H, Morschhauser F, Ternant D, Xerri L, Tarte K, Pranger D. Randomized Phase III Trial Evaluating Subcutaneous Rituximab for the First-Line Treatment of Low-Tumor Burden Follicular Lymphoma: Results of a LYSA Study. J Clin Oncol. 2023 Jul 1;41(19):3523-3533. doi: 10.1200/JCO.22.02327. Epub 2023 Apr 18.

    PubMed 37071836

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab IV and Rituximab SC in people with Follicular Lymphoma, run by The Lymphoma Academic Research Organisation at 50 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 19 inclusion and 19 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 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 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 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 (PFS) (time frame: 5.5 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 NCT02303119, 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 10 Jan 2023.

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