Trial Title:
Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5
NCT ID:
NCT06284122
Condition:
Follicular Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Prednisone
Cyclophosphamide
Bendamustine Hydrochloride
Rituximab
Doxorubicin
Lenalidomide
Obinutuzumab
Vincristine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Mosunetuzumab
Description:
5 mg (step-up dosing) Day 1 of C1 45 mg Day 8 and Day 15 of C1, 45 mg Day 1 from C2 to
C12, 45 mg Day 1 from C13 to C21
Arm group label:
Mosun-Len
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
20 mg/day Day 1 to Day 21 from C2 to C12
Arm group label:
Mosun-Len
Intervention type:
Drug
Intervention name:
Rituximab
Description:
when associated to CHOP IV 375mg/m² SC 1400 mg allowed from C2 Day 1 of C1 Day 1 from C2
to C6 Day 1 from C7 to C20
Arm group label:
R-CHOP
Intervention type:
Drug
Intervention name:
Obinutuzumab
Description:
when associated to CHOP 1000 mg Day 1, Day 8, Day 15 of C1 Day 1 from C2 to C8 Day 1 from
C9 to C18
Arm group label:
G-CHOP
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
750 mg/m2 Day 1 from C1 to C6
Arm group label:
G-CHOP
Arm group label:
R-CHOP
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
50 mg/m2 Day 1 from C1 to C6
Arm group label:
G-CHOP
Arm group label:
R-CHOP
Intervention type:
Drug
Intervention name:
Vincristin
Description:
1.4 mg/m2 (cap cf. below)$ Day 1 from C1 to C6
Arm group label:
G-CHOP
Arm group label:
R-CHOP
Intervention type:
Drug
Intervention name:
Prednisone
Description:
100 mg/day Day 1 to Day 5 from C1 to C6
Arm group label:
G-CHOP
Arm group label:
R-CHOP
Intervention type:
Drug
Intervention name:
Rituximab
Description:
when associated to bendamustin IV 375mg/m² SC 1400 mg allowed from C2 Day 1 of C1 Day 1
from C2 to C6 Day 1 from C7 to C18
Arm group label:
R-Benda
Intervention type:
Drug
Intervention name:
Obinutuzumab
Description:
when associated to bendamustin 1000 mg Day 1, Day 8, Day 15 of C1 Day 1 from C2 to C8 Day
1 from C9 to C20
Arm group label:
G-Benda
Intervention type:
Drug
Intervention name:
Bendamustin
Description:
90 mg/m2 Day 1 and Day 2 from C1 to C6
Arm group label:
G-Benda
Arm group label:
R-Benda
Summary:
This study is a phase III, randomized, open-label, international, multicenter,
interventional trial, designed to compare the efficacy and safety of mosunetuzumab in
combination with lenalidomide versus anti-CD20 monoclonal antibody (mAb) plus
chemotherapy in patients with previously untreated FLIPI 2-5 follicular lymphoma.
Detailed description:
This study is a phase III, randomized, open-label, international, multicenter,
interventional trial, designed to compare the efficacy and safety of mosunetuzumab in
combination with lenalidomide versus anti-CD20 monoclonal antibody (mAb) plus
chemotherapy in patients with previously untreated Follicular Lymphoma International
Prognostic Index (FLIPI) 2-5 follicular lymphoma This study is composed of a screening
period (up to 6 weeks before randomization, i.e., 42 days), a treatment period (30 months
i.e., 125w), a safety follow-up period (90 days i.e., 3 months), and a survival follow-up
period (up to 7 years after the last randomized patient). The enrollment will last
approximately 34 months. The total duration of the study will be therefore approximately
10 years.
Once a patient provides written consent, they may enter the screening phase, with a
duration up to 6 weeks prior to randomization and initiation of treatment.
Upon completion of the required assessments in the screening phase, and fulfillment of
the eligibility criteria, patients will be randomized. Investigators will be requested to
indicate their treatment choice among permitted immuno-chemotherapy regimens just before
randomization.
The treatment period for each patient starts with the first intake. The patients will
receive protocol-specified treatments until:
- inability to achieve a response at the end of induction phase (at M12 evaluation for
experimental arm, and at M6 evaluation for control arms),
- relapse or progression of the disease,
- withdrawal of consent,
- or unacceptable toxicity
In the experimental arm, patients will be treated for 1 cycle of 3 weeks for
mosunetuzumab and then 11 cycles of 4 weeks for mosunetuzumab and lenalidomide (47 weeks,
around 11 months) during the induction phase, and for a maximum of 9 additional cycles of
8 weeks during the maintenance phase (72 weeks, around 17 months), up to around 125 weeks
(30 months). Patients should start the maintenance phase 7 to 8 weeks after the start of
last induction cycle (C12).
In the control arm, patients will be treated for 8 or 6 cycles of 3 or 4 weeks for
anti-CD20 mAb +cyclophosphamide-doxorubicine-vincristine-prednisone (CHOP) or anti-CD20
mAb + Bendamustine, respectively, depending on the assigned arm (24 weeks, around 5
months) during the induction phase, and for a maximum of 12 additional cycles of 8 weeks
during the maintenance phase (96 weeks, around 22 months), up to around 125 weeks (30
months). Patients should start the maintenance phase, 6 to 7 or 7 to 8 weeks after the
start of last induction cycle (C8 or C6).
The option to cross-over from the control arm to the experimental arm is not allowed.
All randomized patients will be followed for progression-free survival and overall
survival using the same schedule. Patients will be followed up from End of treatment
evaluation every 3 months during the first two years, then every 6 months during the next
3 years, then yearly until the end of study.
The end of study will occur when all randomized patients have been followed-up for
survival for at least 7 years (or discontinued study early).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patient with histologically proven previously untreated CD20+ follicular lymphoma
grade 1, 2, or 3a (including patient watched during up to 10 years after initial
diagnosis) as assessed by the investigators according to the World Health
Organization (WHO) 2016 classification12, or classical follicular lymphoma according
to the WHO 2022 classification13. Diagnostic tissue must be available for central
pathology review, exploratory endpoints and secondary data use. (Patients with
absolute lymphocyte count > 20 G/L must be discussed with the Sponsor before
screening/inclusion).
2. FLIPI 2-5.
3. All Ann Arbor stages (including stage I if FLIPI ≥ 2).
4. Must need treatment as evidenced by at least one of the following criteria:
- Bulky disease defined as:
- a nodal or extranodal mass/lesion > 7 cm in its largest diameter or,
- involvement of at least 3 nodal or extranodal sites (each with a diameter
greater than > 3 cm)
- Presence of at least one of the following B symptoms:
- fever (> 38°C) of unclear etiology
- night sweats
- weight loss greater than 10% within the prior 6 months
- Symptomatic splenomegaly
- Any compressive syndrome (for example, but not restricted to- ureteral,
orbital, gastrointestinal)
- Any one of the following cytopenias due to lymphoma:
- hemoglobin < 10g/dL (6.25 mmol/L)
- platelets <100 x 109/L, or
- absolute neutrophil count (ANC) < 1.5 x 109/L
- Pleural or peritoneal serous effusion (irrespective of cell content)
- β2microglobulin > ULN or lactate dehydrogenase (LDH) > ULN
5. At least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its
longest dimension, or at least one bi-dimensionally measurable extra nodal lesion,
defined as > 1.0 cm in its longest dimension (and 18F-2-fluoro-2-deoxy-D-glucose
(FDG)-avid lesion).
6. Patient who understood and voluntarily signed and dated an informed consent prior to
any study-specific assessments/procedures.
7. Must be ≥ 18 years at the time of signing the informed consent form (ICF).
8. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
9. Estimated minimum life expectancy of 3 months.
10. Adequate hematological function within 28 days prior to signing informed consent,
including:
- Absolute neutrophil count (ANC) ≥ 1 x 109/L
- Platelet count ≥ 75 x 109/L, or ≥ 30 x 109/L if bone marrow infiltration or
splenomegaly
- Hemoglobin ≥ 8.0 g/dL (5 mmol/L) unless related to bone marrow infiltration or
splenomegaly. Transfusion is allowed before starting treatment (no required
window)
11. Normal laboratory values:
- Measured or estimated creatinine clearance ≥ 40 mL/min calculated by
institutional standard method (MDRD or Cockcroft-Gault)
- aspartate aminotransferase (AST) or alanine aminotransférase (ALT) ≤ 2.5 x the
upper limit of normal (ULN), except in patients with documented liver or
pancreatic involvement by lymphoma ≤ 5 x ULN
- Serum total bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN for patients with Gilbert
syndrome), except in patients with documented liver or pancreatic involvement
by lymphoma ≤ 3 x ULN
12. left ventricular ejection fraction (LVEF) within normal range (i.e. > 50% as
evaluated by Transthoracic Echocardiography or > 45% as evaluated by isotopic method
(MUGA scan)).
13. Patients should be able to receive adequate prophylaxis and/or therapy for
thromboembolic events (aspirin, low molecular weight heparin or direct oral
anticoagulants).
Patients with a curative anticoagulation therapy can be enrolled. A patient with
deep vein thrombosis due to compressive syndrome is eligible if a curative
anticoagulation therapy has been started at least 1 week before initiating study
treatment: low molecular weight heparin possible at treatment onset, then direct
oral anticoagulants according to local practices.
14. Must be able to adhere to the study visit schedule and other protocol requirements.
15. Negative SARS-CoV-2 test within 7 days prior to randomization. Rapid antigen test is
also acceptable. If a patient has a positive SARS-CoV-2 test before randomization,
another test should be done and be negative within 7 days before initiation of
treatment.
16. Negative HIV test before randomization, with the following exception:
Patients with a positive HIV test before randomization are eligible provided they
are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200/
µL, have an undetectable viral load, and have not had a history of opportunistic
infection attributable to AIDS within the last 12 months.
17. For women of childbearing potential (WOCBP) (refer to section 14.7): must have a
negative result for pregnancy test (highly sensitive serum) at screening and within
7 days before initiation of study treatment, and agree to abstain from breastfeeding
during study participation, and for at least 28 days after the final dose of
lenalidomide (if applicable), 3 months after the final dose of mosunetuzumab and
tocilizumab (if applicable), 6 months after the final dose of chemotherapies (if
applicable), 12 months after the final dose of rituximab (if applicable), and 18
months after the final dose of obinutuzumab (if applicable).
18. For men (refer to section 14.7): Agreement to remain abstinent (refrain from
heterosexual intercourse) or use a condom, and agreement to refrain from donating
sperm, as defined below: with a female partner of childbearing potential or pregnant
female partner, men must remain abstinent or use a condom during the treatment
period (including periods of treatment interruption), and for at least 28 days after
the final dose of lenalidomide (if applicable), 2 months after the final dose of
tocilizumab (if applicable), 6 months after the final dose of chemotherapies (if
applicable), 12 months after the final dose of rituximab (if applicable), and 3
months after the final dose of obinutuzumab (if applicable).
19. Patient covered by any social security system (France).
20. Patient who understands and speaks one of the country official languages, unless
local regulation authorizes independent translators.
Exclusion Criteria:
1. Grade 3b follicular lymphoma according to the WHO 2016 classification12, or
follicular large B-cell lymphoma according to the WHO 2022 classification13.
2. Suspicion or clinical evidence of transformed lymphoma at enrollment by investigator
assessment (e.g., high SUV in at least one lesion that was not biopsied, and
discordant with SUV of biopsied lesion (at least double of the average SUV), LDH >
2.5 x ULN especially in a context of rapidly progressive disease, etc. (Please
contact the Sponsor to discuss any possible inclusion in borderline cases or any
doubt)
3. Prior localized radiotherapy for the FL.
4. Prior history of another lymphoma.
5. Uncontrolled symptomatic pleural or serous effusion requiring urgent treatment
within 48 hours (patients with controlled disease after adequate pleural/serous
drainage and/or effective pleurX™ or similar system are eligible).
6. Uncontrolled symptomatic ureterohydronephrosis resulting in renal failure (patients
with adequate management i.e. ureteral catheter or double J stent allowing renal
failure control are eligible).
7. Symptomatic lymphomatous epidural lesion (patients whose disease is controlled by
neurosurgery or short course of steroids are eligible).
8. Use of any standard or experimental anti-cancer drug therapy within 42 days of the
start (Day 1) of study treatment.
9. Systemic immunosuppressive medications (including, but not limited to,
cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis
factor agents) or corticosteroid > 1mg/kg/day prednisone or equivalent within 10
days prior to first dose of study treatment. Systemic corticosteroid treatment < 20
mg/day of prednisone or equivalent, inhaled corticosteroids and mineralocorticoids
for management of orthostatic hypotension is permitted. A single dose of
dexamethasone for nausea or B symptoms is permitted.
10. Received a live, attenuated vaccine within 4 weeks before the first dose of study
treatment, or in whom it is anticipated that such a live attenuated vaccine will be
required during the study period or within 5 months after the final dose of study
treatment.
11. Major surgery (excluding surgical documentation of FL) within 28 days prior to
signing informed consent.
12. Seropositive for or active viral infection with Hepatitis B virus (HBV):
- HBsAg positive
- HBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable viral
DNA (Patients who are HBsAg negative, anti-HBs positive and/or anti-HBc
positive but viral DNA negative are eligible. They should be treated and
perform testing at regular interval; Patients who are seropositive due to a
history of hepatitis B vaccine (anti-HBs positive) are eligible).
13. Known seropositive for, or active infection hepatitis C virus (HCV) (Patients who
are positive for HCV antibody with a negative viral RNA are eligible).
14. Known or suspected hypersensitivity to biopharmaceuticals produced in Chinese
hamster ovarian (CHO) cells or any component of the mosunetuzumab, Anti-CD20 mAb,
tocilizumab, lenalidomide formulation, including mannitol; or to any of the
excipients.
15. History of solid organ transplantation or allogeneic stem cell transplant (SCT).
16. Active autoimmune disease requiring treatment.
17. History of autoimmune disease, including, but not limited to, myasthenia gravis,
myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,
inflammatory bowel disease, vascular thrombosis associated with antiphospholipid
syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome,
multiple sclerosis, vasculitis, or glomerulonephritis
- Participants with a history of autoimmune-related hypothyroidism on a stable
dose of thyroid replacement hormone may be eligible.
- Participants with controlled Type 1 diabetes mellitus who are on an insulin
regimen are eligible for the study.
- Participants with a history of disease-related immune thrombocytopenic purpura
or autoimmune hemolytic anemia may be eligible.
- Participants with a remote history of, or well-controlled autoimmune disease,
with a treatment-free interval from immunosuppressive therapy for 12 months may
be eligible after review and discussion with the Primary investigator.
18. Participants with any active infection such as known active bacterial, viral
(including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection
(excluding fungal infections of nail beds), known or suspected chronic active
Epstein-Barr virus (EBV) infection, are excluded.
19. Evidence of any significant, concomitant disease that could affect compliance with
the protocol or interpretation of results, including, but not limited to:
- significant cardiovascular disease [e.g., Objective Class C or D heart diseases
(cf. Classes of Heart Failure | American Heart Association), myocardial
infarction within the previous 6 months, unstable arrhythmia, or unstable
angina)
- significant pulmonary disease (such as obstructive pulmonary disease or history
of bronchospasm)
- clinically significant history of liver disease, including viral or other
hepatitis, or cirrhosis
- current or past history of central nervous system (CNS) disease, such as
stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Participants
with a history of stroke who have not experienced a stroke or transient
ischemic attack in the past 1 year and have no residual neurologic deficits as
judged by the investigator are allowed. Participants with a history of epilepsy
who have had no seizures in the past 2 years with or without anti-epileptic
medications can be eligible.
20. History of confirmed progressive multifocal leukoencephalopathy (PML).
21. Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).
22. History of erythema multiforme, Grade ≥3 rash, or blistering rash following prior
treatment with immunomodulatory derivatives.
23. History of interstitial lung disease (ILD), drug-induced pneumonitis, and autoimmune
pneumonitis.
24. Active malignancy other than the one treated in this research. Prior history of
malignancies unless the patient has been free of the disease for ≥ 3 years. However,
patients with the following history/concurrent conditions are eligible:
- Localized non-melanoma skin cancer.
- Carcinoma in situ of the cervix.
- Carcinoma in situ of the breast.
- Incidental histologic finding of prostate cancer (T1a or T1b as per Tumor Node
Metastasis (TNM) staging system) or prostate cancer that has been treated with
curative intent.
25. Presence or history of CNS or meningeal involvement by lymphoma.
26. Pregnant, planning to become pregnant or lactating WOCBP.
27. Any significant medical conditions, including the presence of laboratory abnormality
or psychiatric illness which places the patient at unacceptable risk if he/she were
to participate in the study, and likely to interfere with participation in this
clinical study (according to the investigator's decision) or which confounds the
ability to interpret data from the study.
28. Person deprived of his/her liberty by a judicial or administrative decision.
29. Person hospitalized without consent.
30. Adult person under legal protection.
Nota bene: for 28., if there is an individual benefit for such patients, an Ethics
Committee will have to be informed case by case.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AZ SINT-JAN BRUGGE - OOSTENDE AV - Service Hématologie
Address:
City:
Brugge
Zip:
8000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Sylvia SNAUWAERT, Pr
Facility:
Name:
INSTITUT JULES BORDET - Service Hématologie
Address:
City:
Bruxelles
Zip:
1070
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Marie MAEREVOET, MD
Facility:
Name:
UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service Hématologie
Address:
City:
Bruxelles
Zip:
1200
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Eric VAN DEN NESTE, Pr
Facility:
Name:
GRAND HOPITAL DE CHARLEROI - Service Hématologie
Address:
City:
Charleroi
Zip:
6000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Delphine PRANGER, MD
Facility:
Name:
UNIVERSITAIR ZIEKENHUIS GENT - Service Hématologie
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Ciel DE WRIENDT, MD
Facility:
Name:
CHU DE LIEGE - Service Hématologie
Address:
City:
Liège
Zip:
4000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Christophe BONNET, Pr
Facility:
Name:
CHR VERVIERS - LA TOURELLE - Service Hématologie
Address:
City:
Verviers
Zip:
4800
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Gaetan VANSTRAELEN, MD
Facility:
Name:
CHU UCL NAMUR - SITE GODINNE - Service Hématologie
Address:
City:
Yvoir
Zip:
5530
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Gilles CROCHET, MD
Facility:
Name:
CH d'AVIGNON - HOPITAL HENRI DUFFAUT - Service d'Onco-Hématologie
Address:
City:
Avignon
Zip:
84000
Country:
France
Status:
Recruiting
Contact:
Last name:
Hacène ZERAZHI, MD
Facility:
Name:
CH DE LA COTE BASQUE - Service Hématologie
Address:
City:
Bayonne
Zip:
64100
Country:
France
Status:
Recruiting
Contact:
Last name:
Sophie BERNARD, MD
Facility:
Name:
CHU JEAN MINJOZ - Service Hématologie
Address:
City:
Besançon
Zip:
25030
Country:
France
Status:
Recruiting
Contact:
Last name:
Adrien CHAUCHET, MD
Facility:
Name:
INSTITUT BERGONIE - Service d'Oncologie Médicale
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Recruiting
Contact:
Last name:
Fontanet BIJOU, MD
Facility:
Name:
CENTRE HOSPITALIER JEAN ROUGIER - Service d'Oncologie - Hématologie
Address:
City:
Cahors
Zip:
46005
Country:
France
Status:
Recruiting
Contact:
Last name:
Martin GAUTHIER, MD
Facility:
Name:
CH METROPOLE SAVOIE - SITE CHAMBERY - Service Hématologie
Address:
City:
Chambéry
Zip:
73011
Country:
France
Status:
Recruiting
Contact:
Last name:
Arthur DONY, MD
Facility:
Name:
CHU ESTAING - Service Thérapie Cellulaire et Hématologie Clinique
Address:
City:
Clermont-Ferrand
Zip:
63003
Country:
France
Status:
Recruiting
Contact:
Last name:
Romain GUIEZE, Pr
Facility:
Name:
HOPITAL HENRI MONDOR - Unité Hémopathies Lymphoïdes
Address:
City:
Créteil
Zip:
94010
Country:
France
Status:
Recruiting
Contact:
Last name:
François LEMONNIER, MD
Facility:
Name:
CHU DIJON BOURGOGNE - Service Hématologie Clinique
Address:
City:
Dijon
Zip:
21000
Country:
France
Status:
Recruiting
Contact:
Last name:
Amandine DURAND, MD
Facility:
Name:
CHD DE VENDEE - Service Hématologie
Address:
City:
La Roche-sur-Yon
Zip:
85925
Country:
France
Status:
Recruiting
Contact:
Last name:
Nadine MORINEAU, MD
Facility:
Name:
CHU DE GRENOBLE - Service Hématologie
Address:
City:
La Tronche
Zip:
38700
Country:
France
Status:
Recruiting
Contact:
Last name:
Sylvain CARRAS, MD
Facility:
Name:
HOPITAL SAINT VINCENT-DE-PAUL - Service Hématologie
Address:
City:
Lille
Zip:
59020
Country:
France
Status:
Recruiting
Contact:
Last name:
Sandy AMORIM, MD
Facility:
Name:
CHRU DE LILLE - HOPITAL CLAUDE HURIEZ - Service Hématologie
Address:
City:
Lille
Zip:
59037
Country:
France
Status:
Recruiting
Contact:
Last name:
Franck MORSCHHAUSER, Pr
Facility:
Name:
CHU DE LIMOGES - HOPITAL DUPUYTREN - Service Hématologie Clinique et Thérapie Cellulaire
Address:
City:
Limoges
Zip:
87042
Country:
France
Status:
Recruiting
Contact:
Last name:
Julie ABRAHAM, MD
Facility:
Name:
INSTITUT PAOLI CALMETTES - Service Hématologie
Address:
City:
Marseille
Zip:
13273
Country:
France
Status:
Recruiting
Contact:
Last name:
Gabriel BRISOU, MD
Facility:
Name:
CHU DE MONTPELLIER - Département d'Hématologie Clinique
Address:
City:
Montpellier
Zip:
34090
Country:
France
Status:
Recruiting
Contact:
Last name:
Guillaume CARTRON, Pr
Facility:
Name:
GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER - Service Hématologie
Address:
City:
Mulhouse
Zip:
68100
Country:
France
Status:
Recruiting
Contact:
Last name:
Bernard DRENOU, MD
Facility:
Name:
CHU DE NANTES - Service Hématologie
Address:
City:
Nantes
Zip:
44093
Country:
France
Status:
Recruiting
Contact:
Last name:
Thomas GASTINNE, MD
Facility:
Name:
CENTRE HOSPITALIER DE NIORT - Médecine interne
Address:
City:
Niort
Zip:
79021
Country:
France
Status:
Recruiting
Contact:
Last name:
Gaëlle OLIVIER, MD
Facility:
Name:
HOPITAL SAINT-LOUIS - Service Hématologie
Address:
City:
Paris
Zip:
75475
Country:
France
Status:
Recruiting
Contact:
Last name:
Catherine THIEBLEMONT, Pr
Facility:
Name:
CHU DE BORDEAUX - HOPITAL HAUT-LEVEQUE - CENTRE FRANCOIS MAGENDIE - Service d'Hématologie et Thérapie Cellulaire
Address:
City:
Pessac
Zip:
33604
Country:
France
Status:
Recruiting
Contact:
Last name:
François-Xavier GROS, MD
Facility:
Name:
CHU LYON-SUD - Hématologie
Address:
City:
Pierre-Bénite
Zip:
69495
Country:
France
Status:
Recruiting
Contact:
Last name:
Emmanuel BACHY, Pr
Facility:
Name:
CHI POISSY SAINT-GERMAIN-EN-LAYE - Service Hématologie
Address:
City:
Poissy
Zip:
78303
Country:
France
Status:
Recruiting
Contact:
Last name:
Mohammed BOUDERBALA, MD
Facility:
Name:
CHU DE POITIERS - HOPITAL DE LA MILETRIE - Service d'Oncologie Hématologique et Thérapie Cellulaire
Address:
City:
Poitiers
Zip:
86021
Country:
France
Status:
Recruiting
Contact:
Last name:
Stéphanie GUIDEZ, MD
Facility:
Name:
CH ANNECY GENEVOIS - SITE D'ANNECY - Service Hématologie
Address:
City:
Pringy
Zip:
74374
Country:
France
Status:
Recruiting
Contact:
Last name:
Hannah MOATTI, MD
Facility:
Name:
CHU DE REIMS - HOPITAL ROBERT DEBRE - Service Hématologie
Address:
City:
Reims
Zip:
57092
Country:
France
Status:
Recruiting
Contact:
Last name:
Eric DUROT, MD
Facility:
Name:
CHU PONTCHAILLOU - Hématologie Clinique
Address:
City:
Rennes
Zip:
35033
Country:
France
Status:
Recruiting
Contact:
Last name:
Roch HOUOT, Pr
Facility:
Name:
CENTRE HENRI BECQUEREL - Service Hématologie
Address:
City:
Rouen
Zip:
76038
Country:
France
Status:
Recruiting
Contact:
Last name:
Fabrice JARDIN, Pr
Facility:
Name:
INSTITUT CURIE - SITE SAINT-CLOUD - Service Hématologie
Address:
City:
Saint-Cloud
Zip:
92210
Country:
France
Status:
Recruiting
Contact:
Last name:
Clémentine SARKOZY, MD
Facility:
Name:
Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie
Address:
City:
Saint-Priest-en-Jarez
Zip:
42270
Country:
France
Status:
Recruiting
Contact:
Last name:
Ludovic FOUILLET, MD
Facility:
Name:
INSTITUT DE CANCEROLOGIE STRASBOURG EUROPE - Unité de Recherche Clinique
Address:
City:
Strasbourg
Zip:
67033
Country:
France
Status:
Recruiting
Contact:
Last name:
Luc-Matthieu FORNECKER, Pr
Facility:
Name:
IUCT ONCOPOLE - Service Hématologie
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Contact:
Last name:
Loïc YSEBAERT, MD
Facility:
Name:
CHU BRETONNEAU - Service Cancérologie - Hématologie et Thérapie Cellulaire
Address:
City:
Tours
Zip:
37044
Country:
France
Status:
Recruiting
Contact:
Last name:
Laurianne DRIEU LA ROCHELLE, MD
Facility:
Name:
CH DE VALENCIENNES - HOPITAL JEAN BERNARD - Service Hématologie
Address:
City:
Valenciennes
Zip:
59322
Country:
France
Status:
Recruiting
Contact:
Last name:
Sabine TRICOT, MD
Facility:
Name:
CHU BRABOIS - Service Hématologie
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54511
Country:
France
Status:
Recruiting
Contact:
Last name:
Pierre FEUGIER, Pr
Facility:
Name:
CH DE BRETAGNE ATLANTIQUE - HOPITAL CHUBERT - Service Hématologie
Address:
City:
Vannes
Zip:
56017
Country:
France
Status:
Recruiting
Contact:
Last name:
Antoine BONNET, MD
Facility:
Name:
GUSTAVE ROUSSY CANCER CAMPUS GRAND PARIS - Département Médecine Oncologique
Address:
City:
Villejuif
Zip:
94085
Country:
France
Status:
Recruiting
Contact:
Last name:
Vincent RIBRAG, MD
Facility:
Name:
UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III
Address:
City:
Regensburg
Zip:
93053
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Stephanie MAYER, MD
Facility:
Name:
UNIV KLINIKUM ULM - INNERE MEDIZIN III - Service Hématologie
Address:
City:
Ulm
Zip:
89081
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Christian BUSKE, Pr
Facility:
Name:
INSTITUTO PORTUGUES DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL - Departamento Hematologia
Address:
City:
Lisboa
Zip:
1099
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Maria GOMES DA SILVA, Pr
Facility:
Name:
HOSPITAL CLINICO SALAMANCA - Servicio de Hematologia
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Alejandro MARTIN GARCIA-SANCHO, MD
Start date:
June 7, 2024
Completion date:
April 2034
Lead sponsor:
Agency:
The Lymphoma Academic Research Organisation
Agency class:
Other
Collaborator:
Agency:
Lymphoma Study Association
Agency class:
Other
Collaborator:
Agency:
Swiss Group for Clinical Cancer Research
Agency class:
Other
Collaborator:
Agency:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Agency class:
Other
Source:
The Lymphoma Academic Research Organisation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06284122
