Clinical trial NCT06284122: Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5
Official title: A Phase III Randomized, Open-label, International, Multicenter Study Evaluating the Efficacy and Safety of Mosunetuzumab Plus Lenalidomide in Comparison to Anti-CD20 Monoclonal Antibody Plus Chemotherapy in Subjects With Previously Untreated FLIPI 2-5 Follicular Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Follicular Lymphoma
Lead sponsor: The Lymphoma Academic Research Organisation
Sponsor class: OTHER
Collaborators: name: Lymphoma Study Association
name: Swiss Group for Clinical Cancer Research
name: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
First posted: 2024-02-28
Enrollment: 790
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 130 PFS events assessed by an Independent Review Committee (IRC) (4.6 years)
measure: Progression Free Survival (PFS)
timeFrame: 173 PFS events assessed by IRC (5.8 y)
Secondary outcomes:
measure: Overall Response (OR)
timeFrame: 6 months
measure: Complete Metabolic Rate (CMR)
timeFrame: 6 months
measure: Overall Response (OR)
timeFrame: 12 months
measure: Complete Metabolic Rate (CMR)
timeFrame: 12 months
measure: Best Overall Response (CMR + PMR) rate
timeFrame: 4.6 years
measure: Best Overall Response (CMR + PMR) rate
timeFrame: 5.8 years
measure: Progression of disease within 2 years (POD24)
timeFrame: 2 years
measure: PFS
timeFrame: 4.6 years
measure: PFS
timeFrame: 5.8 years
measure: Event Free Survival (EFS) by Lugano 2014
timeFrame: 4.6 years
measure: Event Free Survival (EFS) by Lugano 2014
timeFrame: 5.8 years
measure: Time to Next Anti-Lymphoma Treatment (TTNLT)
timeFrame: 4.6 years
measure: Time to Next Anti-Lymphoma Treatment (TTNLT)
timeFrame: 5.8 years
measure: Duration of response
timeFrame: 4.6 years
measure: Duration of response
timeFrame: 5.8 years
measure: Overall Response (OR)
timeFrame: End of treatment (12 months for experimental arm, 6 months for comparative arms)
measure: Complete Metabolic Rate (CMR)
timeFrame: End of treatment (12 months for experimental arm, 6 months for comparative arms)
measure: Duration of complete response
timeFrame: 4.6 years
measure: Duration of complete response
timeFrame: 5.8 years
measure: Overall Survival (OS)
timeFrame: 4.6 years
measure: Overall Survival (OS)
timeFrame: 5.8 years
measure: Incidence and severity of Adverse Events (AE) including Serious and Special Interest AE (SAEs and AESIs)
timeFrame: 4.6 years
measure: Incidence and severity of AEs including SAEs and AESIs
timeFrame: 5.8 years
measure: Tolerability, as assessed by incidence of dose interruptions, delays, dose reductions, and study treatment discontinuation
timeFrame: 4.6 years
measure: Tolerability, as assessed by incidence of dose interruptions, delays, dose reductions, and study treatment discontinuation
timeFrame: 5.8 years
measure: Incidence of Second Primary Malignancies (SPM)
timeFrame: 4.6 years
measure: Incidence of Second Primary Malignancies (SPM)
timeFrame: 5.8 years
measure: anti-drug antibodies (ADA) to mosunetuzumab
timeFrame: each cycle, 18 months, 24 months, 30 months
measure: Time to deterioration in physical functioning
timeFrame: baseline, 6 months, 12 months, 18 months, 24 months, 30 months or end of treatment
measure: Time to deterioration in lymphoma symptoms
timeFrame: baseline, 6 months, 12 months, 18 months, 24 months, 30 months or end of treatment
measure: Maximum serum concentration of mosunetuzumab - Cmax
timeFrame: each cycle, 18 months, 24 months, 30 months
measure: Minimum serum concentration of mosunetuzumab - Cmin
timeFrame: each cycle, 18 months, 24 months, 30 months
measure: Area under the curve of serum concentration of mosunetuzumab - AUC
timeFrame: each cycle, 18 months, 24 months, 30 months
measure: Maximum serum concentration of lenalidomide - Cmax
timeFrame: each cycle, 18 months, 24 months, 30 months
measure: Minimum serum concentration of lenalidomide - Cmin
timeFrame: each cycle, 18 months, 24 months, 30 months
measure: Area under the curve of serum concentration of lenalidomide - AUC
timeFrame: each cycle, 18 months, 24 months, 30 months
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ SINT-JAN BRUGGE - OOSTENDE AV - Service Hématologie
city: Bruxelles
country: Belgium
facility: INSTITUT JULES BORDET - Service Hématologie
city: Bruxelles
country: Belgium
facility: UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service Hématologie
city: Charleroi
country: Belgium
facility: GRAND HOPITAL DE CHARLEROI - Service Hématologie
city: Gent
country: Belgium
facility: UNIVERSITAIR ZIEKENHUIS GENT - Service Hématologie
city: Liège
country: Belgium
facility: CHU DE LIEGE - Service Hématologie
city: Verviers
country: Belgium
facility: CHR VERVIERS - LA TOURELLE - Service Hématologie
city: Yvoir
country: Belgium
facility: CHU UCL NAMUR - SITE GODINNE - Service Hématologie
city: Avignon
country: France
facility: CH d'AVIGNON - HOPITAL HENRI DUFFAUT - Service d'Onco-Hématologie
city: Bayonne
country: France
facility: CH DE LA COTE BASQUE - Service Hématologie
city: Besançon
country: France
facility: CHU JEAN MINJOZ - Service Hématologie
city: Bordeaux
country: France
facility: INSTITUT BERGONIE - Service d'Oncologie Médicale
city: Cahors
country: France
facility: CENTRE HOSPITALIER JEAN ROUGIER - Service d'Oncologie - Hématologie
city: Chambéry
country: France
facility: CH METROPOLE SAVOIE - SITE CHAMBERY - Service Hématologie
city: Clermont-Ferrand
country: France
facility: CHU ESTAING - Service Thérapie Cellulaire et Hématologie Clinique
city: Créteil
country: France
facility: HOPITAL HENRI MONDOR - Unité Hémopathies Lymphoïdes
city: Dijon
country: France
facility: CHU DIJON BOURGOGNE - Service Hématologie Clinique
city: La Roche-sur-Yon
country: France
facility: CHD DE VENDEE - Service Hématologie
city: La Tronche
country: France
facility: CHU DE GRENOBLE - Service Hématologie
city: Lille
country: France
facility: HOPITAL SAINT VINCENT-DE-PAUL - Service Hématologie
city: Lille
country: France
facility: CHRU DE LILLE - HOPITAL CLAUDE HURIEZ - Service Hématologie
city: Limoges
country: France
facility: CHU DE LIMOGES - HOPITAL DUPUYTREN - Service Hématologie Clinique et Thérapie Cellulaire
city: Marseille
country: France
facility: INSTITUT PAOLI CALMETTES - Service Hématologie
city: Montpellier
country: France
facility: CHU DE MONTPELLIER - Département d'Hématologie Clinique
city: Mulhouse
country: France
facility: GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER - Service Hématologie
city: Nantes
country: France
facility: CHU DE NANTES - Service Hématologie
city: Niort
country: France
facility: CENTRE HOSPITALIER DE NIORT - Médecine interne
city: Paris
country: France
facility: HOPITAL SAINT-LOUIS - Service Hématologie
city: Pessac
country: France
facility: CHU DE BORDEAUX - HOPITAL HAUT-LEVEQUE - CENTRE FRANCOIS MAGENDIE - Service d'Hématologie et Thérapie Cellulaire
city: Pierre-Bénite
country: France
facility: CHU LYON-SUD - Hématologie
city: Poissy
country: France
facility: CHI POISSY SAINT-GERMAIN-EN-LAYE - Service Hématologie
city: Poitiers
country: France
facility: CHU DE POITIERS - HOPITAL DE LA MILETRIE - Service d'Oncologie Hématologique et Thérapie Cellulaire
city: Pringy
country: France
facility: CH ANNECY GENEVOIS - SITE D'ANNECY - Service Hématologie
city: Reims
country: France
facility: CHU DE REIMS - HOPITAL ROBERT DEBRE - Service Hématologie
city: Rennes
country: France
facility: CHU PONTCHAILLOU - Hématologie Clinique
city: Rouen
country: France
facility: CENTRE HENRI BECQUEREL - Service Hématologie
city: Saint-Cloud
country: France
facility: INSTITUT CURIE - SITE SAINT-CLOUD - Service Hématologie
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie
city: Strasbourg
country: France
facility: INSTITUT DE CANCEROLOGIE STRASBOURG EUROPE - Unité de Recherche Clinique
city: Toulouse
country: France
facility: IUCT ONCOPOLE - Service Hématologie
city: Tours
country: France
facility: CHU BRETONNEAU - Service Cancérologie - Hématologie et Thérapie Cellulaire
city: Valenciennes
country: France
facility: CH DE VALENCIENNES - HOPITAL JEAN BERNARD - Service Hématologie
city: Vandœuvre-lès-Nancy
country: France
facility: CHU BRABOIS - Service Hématologie
city: Vannes
country: France
facility: CH DE BRETAGNE ATLANTIQUE - HOPITAL CHUBERT - Service Hématologie
city: Villejuif
country: France
facility: GUSTAVE ROUSSY CANCER CAMPUS GRAND PARIS - Département Médecine Oncologique
city: Regensburg
country: Germany
facility: UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III
city: Ulm
country: Germany
facility: UNIV KLINIKUM ULM - INNERE MEDIZIN III - Service Hématologie
city: Lisboa
country: Portugal
facility: INSTITUTO PORTUGUES DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL - Departamento Hematologia
city: Salamanca
country: Spain
facility: HOSPITAL CLINICO SALAMANCA - Servicio de Hematologia
Study officials:
affiliation: Lymphoma Study Association
name: Franck MORSCHHAUSER
role: PRINCIPAL_INVESTIGATOR
affiliation: GLA
name: Christian BUSKE
role: PRINCIPAL_INVESTIGATOR
References: