Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients

Diffuse Large B-cell Lymphoma Clinical Trial

— frontMIND  

Official title:

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to R-CHOP Versus R-CHOP in Previously Untreated, High-intermediate and High-risk Patients With Newly-diagnosed Diffuse Large B-cell Lymphoma (DLBCL)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04824092
• Other study ID #: MOR208C310
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 11, 2021
• Est. completion date: May 2026

Study information

• Verified date: April 2023
• Source: MorphoSys AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 899
• Est. completion date: May 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Major Inclusion Criteria:

• Previously untreated patients with local biopsy-proven, CD20-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) classification

of lymphoid neoplasms are eligible:

1. DLBCL, NOS including GCB type, ABC type

2. T-cell rich large BCL

3. Epstein-Barr virus-positive DLBCL, NOS

4. Anaplastic lymphoma kinase (ALK)-positive large BCL

5. Human herpes virus-8 (HHV8)-positive DLBCL, NOS

6. High-grade BCL with MYC and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements (double-hit or triple-hit lymphoma). Please note: Patients must be appropriate candidates for R-CHOP. If an investigator deems a patient with a known double- or triple-hit lymphoma (HGBL) should be treated more aggressively (e.g. dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab [DA-EPOCH-R] or cyclophosphamide, vincristine, doxorubicin and dexamethasone (CVAD) followed by methotrexate and cytarabine [Hyper CVAD]), this patient would not be considered eligible for this study

7. HGBL-NOS

8. DLBCL coexistent with either follicular lymphoma (FL) of any grade, gastric MALT lymphoma or non-gastric MALT lymphoma

9. FL grade 3b

• Availability of archival or freshly collected tumor tissue sent for retrospective central pathology review
• IPI status of 3 to 5 (for patients > 60 years of age) or aaIPI 2 to 3 (for patients = 60 years of age)
• Diagnosis to treatment interval, defined as the time between the date of DLBCL diagnosis (date of the first biopsy specimen containing B Cell lymphoma according to the local pathology report) and the start of treatment (C1D1) = 28 days
• ECOG performance status of 0, 1, or 2
• Left ventricular ejection fraction equal to or greater 50% as assessed by local echocardiography or cardiac multi-gated acquisition (MUGA) scan
• Adequate hematologic function
• Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from breast feeding and donating eggs; agreement to ongoing pregnancy testing during the course of the study, and after study therapy has ended
• Male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm

Major Exclusion Criteria:

• Any other histological type of lymphoma according to WHO 2016 classification of lymphoid neoplasms, e.g., primary mediastinal (thymic) large B-cell lymphoma, Burkitt's lymphoma, BCL, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey-zone lymphoma); primary effusion lymphoma; primary cutaneous DLBCL, leg type; primary DLBCL of the CNS; DLBCL arising from CLL or indolent lymphoma
• History of prior non-hematologic malignancy except for the following:

1. Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening

2. Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer

3. Adequately treated carcinoma in situ without current evidence of disease

• Any systemic anti-lymphoma and/or investigational therapy prior to the start of C1D1, except for permitted pre-phase treatment
• Contraindication to any of the individual components of R-CHOP, including prior receipt of anthracyclines
• Known CNS lymphoma involvement
• Known active systemic bacterial, viral, fungal, or other infection at screening, including patients with suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)
• History or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that in the investigator's opinion would preclude participation in the study or compromise the patient's ability to give informed consent

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Tafasitamab
Tafasitamab IV infusion will be administered as per the schedule specified in the respective arm.
• Lenalidomide
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
• Rituximab
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
• Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
• Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
• Vincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
• Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.
• Tafasitamab placebo
0.9% saline solution IV infusion will be administered as per the schedule specified in the respective arm.
• Lenalidomide placebo
Placebo matching to lenalidomide PO will be administered as per the schedule specified in the respective arm.

Locations

Country	Name	City	State
Argentina	MorphoSys Research Site	Buenos Aires
Argentina	MorphoSys Research Site	Buenos Aires
Argentina	MorphoSys Research Site	Cipolletti
Argentina	MorphoSys Research Site	Rosario
Argentina	MorphoSys Research Site	San Miguel de Tucuman
Australia	MorphoSys Research Site	Adelaide
Australia	MorphoSys Research Site	Ballarat
Australia	MorphoSys Research Site	Birtinya
Australia	MorphoSys Research Site	Brisbane
Australia	MorphoSys Research Site	Canberra
Australia	MorphoSys Research Site	Clayton
Australia	MorphoSys Research Site	Frankston
Australia	MorphoSys Research Site	Geelong
Australia	MorphoSys Research Site	Gold Coast
Australia	MorphoSys Research Site	Gosford
Australia	MorphoSys Research Site	Greenslopes
Australia	MorphoSys Research Site	Hobart
Australia	MorphoSys Research Site	Kingswood
Australia	MorphoSys Research Site	Kogarah
Australia	MorphoSys Research Site	Launceston
Australia	MorphoSys Research Site	Malvern
Australia	MorphoSys Research Site	Melbourne
Australia	MorphoSys Research Site	Melbourne
Australia	MorphoSys Research Site	Nedlands
Australia	MorphoSys Research Site	Perth
Australia	MorphoSys Research Site	Perth
Australia	MorphoSys Research Site	Richmond
Australia	MorphoSys Research Site	St. Albans
Australia	MorphoSys Research Site	Sydney
Australia	MorphoSys Research Site	Sydney
Australia	MorphoSys Research Site	Townsville
Australia	MorphoSys Research Site	Wahroonga
Australia	MorphoSys Research Site	Waratah
Australia	MorphoSys Research Site	Wollongong
Austria	MorphoSys Research Site	Innsbruck
Austria	MorphoSys Research Site	Linz
Austria	MorphoSys Research Site	Linz
Austria	MorphoSys Research Site	Rankweil
Austria	MorphoSys Research Site	St. Poelten
Austria	MorphoSys Research Site	Vienna
Austria	MorphoSys Research Site	Vienna
Canada	MorphoSys Research Site	Halifax
Canada	MorphoSys Research Site	London
Canada	MorphoSys Research Site	Montreal
Canada	MorphoSys Research Site	Saskatoon
Canada	MorphoSys Research Site	Sherbrooke
Colombia	MorphoSys Research Site	Medellin
Colombia	MorphoSys Research Site	Valledupar
Czechia	MorphoSys Research Site	Brno
Czechia	MorphoSys Research Site	Hradec Králové
Czechia	MorphoSys Research Site	Olomouc
Czechia	MorphoSys Research Site	Ostrava
Czechia	MorphoSys Research Site	Prague
Czechia	MorphoSys Research Site	Prague
Czechia	MorphoSys Research Site	Prague
France	MorphoSys Research Site	Amiens
France	Morphosys Research Site	Bordeau	Pessac Cedax
France	MorphoSys Research Site	Bordeaux
France	MorphoSys Research Site	Bordeaux
France	Morphosys Research Site	Caen	Cedex 9
France	MorphoSys Research Site	La Tronche
France	Morphosys Research Site	Le Chesnay
France	MorphoSys Research Site	Le Mans
France	MorphoSys Research Site	Lille
France	MorphoSys Research Site	Limoges
France	MorphoSys Research Site	Marseille
France	MorphoSys Research Site	Nantes
France	MorphoSys Research Site	Poitiers
France	MorphoSys Research Site	Quimper
France	MorphoSys Research Site	Saint-Priest-en-Jarez
France	MorphoSys Research Site	Vandoeuvre-lès-Nancy
France	MorphoSys Research Site	Vannes
Germany	MorphoSys Research Site	Aachen
Germany	MorphoSys Research Site	Augsburg
Germany	MorphoSys Research Site	Berlin
Germany	MorphoSys Research Site	Berlin
Germany	Morphosys Research Site	Berlin
Germany	MorphoSys Research Site	Bonn
Germany	MorphoSys Research Site	Chemnitz
Germany	MorphoSys Research Site	Cottbus
Germany	MorphoSys Research Site	Göttingen
Germany	MorphoSys Research Site	Halle
Germany	MorphoSys Research Site	Heilbronn
Germany	MorphoSys Research Site	Jena
Germany	MorphoSys Research Site	Kassel
Germany	MorphoSys Research Site	Luebeck
Germany	MorphoSys Research Site	Magdeburg
Germany	MorphoSys Research Site	Mainz
Germany	MorphoSys Research Site	Marburg
Germany	MorphoSys Research Site	Muenster
Germany	MorphoSys Research Site	Munich
Germany	MorphoSys Research Site	Munich
Germany	MorphoSys Research Site	Paderborn
Germany	MorphoSys Research Site	Tuebingen
Germany	MorphoSys Research Site	Wiesbaden
Germany	MorphoSys Research Site	Wuerzburg
Germany	MorphoSys Research Site	Wuppertal
Hungary	MorphoSys Research Site	Budapest
Hungary	MorphoSys Research Site	Budapest
Hungary	MorphoSys Research Site	Debrecen
Hungary	MorphoSys Research Site	Gyor
Hungary	Morphosys Research Site	Nyíregyháza
Hungary	MorphoSys Research Site	Pécs
Ireland	MorphoSys Research Site	Dublin
Ireland	MorphoSys Research Site	Limerick
Israel	MorphoSys Research Site	Be'er Sheva
Israel	MorphoSys Research Site	Haifa
Israel	MorphoSys Research Site	Jerusalem
Israel	MorphoSys Research Site	Petah-Tikva
Israel	Morphosys Research Site	Ramat Gan
Israel	MorphoSys Research Site	Tel-Aviv
Italy	MorphoSys Research Site	Bergamo
Italy	MorphoSys Research Site	Brescia
Italy	MorphoSys Research Site	Candiolo
Italy	MorphoSys Research Site	Catania
Italy	MorphoSys Research Site	Forli
Italy	MorphoSys Research Site	Genoa
Italy	MorphoSys Research Site	Lecce
Italy	MorphoSys Research Site	Milan
Italy	MorphoSys Research Site	Novara
Italy	MorphoSys Research Site	Orbassano
Italy	MorphoSys Research Site	Padova
Italy	MorphoSys Research Site	Palermo
Italy	MorphoSys Research Site	Pavia
Italy	MorphoSys Research Site	Ravenna
Italy	MorphoSys Research Site	Rimini
Italy	MorphoSys Research Site	Rozzano
Italy	MorphoSys Research Site	Siena
Italy	MorphoSys Research Site	Siena
Italy	MorphoSys Research Site	Terni
Italy	MorphoSys Research Site	Tricase
Italy	MorphoSys Research Site	Trieste
Italy	MorphoSys Research Site	Turin
Japan	MorphoSys Research Site	Fukuoka
Japan	MorphoSys Research Site	Gifu
Japan	MorphoSys Research Site	Ibaraki
Japan	MorphoSys Research Site	Isehara
Japan	MorphoSys Research Site	Kagoshima
Japan	MorphoSys Research Site	Nagoya
Japan	MorphoSys Research Site	Narita-shi
Japan	MorphoSys Research Site	Okayama
Japan	MorphoSys Research Site	Osaka
Japan	MorphoSys Research Site	Osakasayama-shi
Japan	MorphoSys Research Site	Sapporo
Japan	MorphoSys Research Site	Tachikawa
Japan	MorphoSys Research Site	Tokyo
Japan	MorphoSys Research Site	Tokyo
Japan	MorphoSys Research Site	Tokyo
Japan	MorphoSys Research Site	Tsu-shi
Korea, Republic of	MorphoSys Research Site	Busan
Korea, Republic of	MorphoSys Research Site	Busan
Korea, Republic of	MorphoSys Research Site	Busan
Korea, Republic of	MorphoSys Research Site	Busan
Korea, Republic of	MorphoSys Research Site	Daegu
Korea, Republic of	MorphoSys Research Site	Daegu
Korea, Republic of	MorphoSys Research Site	Daegu
Korea, Republic of	MorphoSys Research Site	Goyang-si
Korea, Republic of	MorphoSys Research Site	Incheon
Korea, Republic of	MorphoSys Research Site	Jeonju
Korea, Republic of	MorphoSys Research Site	Jinju-si
Korea, Republic of	MorphoSys Research Site	Seoul
Korea, Republic of	MorphoSys Research Site	Seoul
Korea, Republic of	MorphoSys Research Site	Seoul
Korea, Republic of	MorphoSys Research Site	Seoul
Korea, Republic of	MorphoSys Research Site	Seoul
Korea, Republic of	MorphoSys Research Site	Seoul
Korea, Republic of	MorphoSys Research Site	Yangsan
Malaysia	MorphoSys Research Site	Alor Setar
Malaysia	MorphoSys Research Site	Ampang
Malaysia	MorphoSys Research Site	George Town
Malaysia	MorphoSys Research Site	Ipoh
Malaysia	MorphoSys Research Site	Johor Bahru
Malaysia	MorphoSys Research Site	Kota Bharu
Malaysia	MorphoSys Research Site	Kuala Lumpur
Malaysia	MorphoSys Research Site	Kuantan
Malaysia	MorphoSys Research Site	Kuching
Malaysia	MorphoSys Research Site	Petaling Jaya
Malaysia	MorphoSys Research Site	Subang Jaya
New Zealand	MorphoSys Research Site	Auckland
Philippines	MorphoSys Research Site	Manila
Philippines	MorphoSys Research Site	Pasig City
Philippines	MorphoSys Research Site	Quezon City
Poland	Morphosys Research Site	Lódz
Poland	MorphoSys Research Site	Warsaw
Romania	MorphoSys Research Site	Brasov
Romania	MorphoSys Research Site	Bucharest
Romania	Morphosys Research Site	Bucharest
Romania	Morphosys Research Site	Cluj-Napoca
Romania	Morphosys Research Site	Craiova
Romania	MorphoSys Research Site	Iasi
Russian Federation	MorphoSys Research Site	Kazan
Russian Federation	Morphosys Research Site	Moscow
Russian Federation	MorphoSys Research Site	Novosibirsk
Russian Federation	Morphosys Research Site	Petrozavodsk
Russian Federation	MorphoSys Research Site	Saint Petersburg
Russian Federation	MorphoSys Research Site	Saint Petersburg
Russian Federation	Morphosys Research Site	Saint Petersburg
Russian Federation	Morphosys research site	UFA
Serbia	MorphoSys Research Site	Belgrade
Serbia	MorphoSys Research Site	Belgrade
Serbia	Morphosys Research Site	Novi Sad
Serbia	MorphoSys Research Site	Sremska Kamenica
Slovakia	MorphoSys Research Site	Bratislava
Slovakia	MorphoSys Research Site	Košice
Spain	MorphoSys Research Site	Badalona
Spain	MorphoSys Research Site	Barcelona
Spain	MorphoSys Research Site	Barcelona
Spain	MorphoSys Research Site	Girona
Spain	MorphoSys Research Site	Jerez de la Frontera
Spain	MorphoSys Research Site	Lugo
Spain	MorphoSys Research Site	Madrid
Spain	MorphoSys Research Site	Madrid
Spain	MorphoSys Research Site	Madrid
Spain	MorphoSys Research Site	Madrid
Spain	MorphoSys Research Site	Madrid
Spain	MorphoSys Research Site	Pamplona
Spain	MorphoSys Research Site	Salamanca
Spain	MorphoSys Research Site	Seville
Spain	MorphoSys Research Site	Seville
Spain	MorphoSys Research Site	Seville
Spain	MorphoSys Research Site	Valencia
Spain	MorphoSys Research Site	Vitoria-Gasteiz
Taiwan	Morphosys Research Site	Chang Hua
Taiwan	Morphosys Research Site	Chiayi City
Taiwan	Morphosys Research Site	Hualien City
Taiwan	MorphoSys Research Site	Kaohsiung
Taiwan	Morphosys Research Site	Kaohsiung
Taiwan	Morphosys Research Site	New Taipei City
Taiwan	Morphosys Research Site	Taichung
Taiwan	MorphoSys Research Site	Taichung
Taiwan	MorphoSys Research Site	Tainan
Taiwan	MorphoSys Research Site	Taipei
Taiwan	Morphsys Research Site	Taoyuan
Thailand	MorphoSys Research Site	Bangkok
Thailand	Morphosys Research Site	Bangkok
Thailand	Morphosys Research Site	Chiang Mai
Thailand	Morphosys Research Site	Khon Kaen
Thailand	MorphoSys Research Site	Pathum Thani
Turkey	MorphoSys Research Site	Ankara
Turkey	MorphoSys Research Site	Ankara
Turkey	MorphoSys Research Site	Izmir
Turkey	MorphoSys Research Site	Izmit
Turkey	MorphoSys Research Site	Malatya
Turkey	MorphoSys Research Site	Mersin
Ukraine	Morphosys Research Site	Cherkasy
Ukraine	Morphosys Research Site	Chernihiv
Ukraine	Morphosys Research Site	Kharkiv
Ukraine	Morphosys Research Site	Kyiv
Ukraine	MorphoSys Research Site	Kyiv
Ukraine	Morphosys Research Site	Kyiv
United Kingdom	MorphoSys Research Site	Aberdeen
United Kingdom	MorphoSys Research Site	Bath
United Kingdom	MorphoSys Research Site	Birmingham
United Kingdom	MorphoSys Research Site	Bristol
United Kingdom	MorphoSys Research Site	London
United Kingdom	MorphoSys Research Site	London
United Kingdom	Morphosys Research Site	London
United Kingdom	MorphoSys Research Site	Nottingham
United Kingdom	MorphoSys Research Site	Sutton
United Kingdom	MorphoSys Research Site	Wolverhampton
United States	MorphoSys Research Site	Anaheim	California
United States	MorphoSys Research Site	Aurora	Colorado
United States	MorphoSys Research Site	Austin	Texas
United States	MorphoSys Research Site	Baltimore	Maryland
United States	MorphoSys Research Site	Bedford	Texas
United States	MorphoSys Research Site	Bethesda	Maryland
United States	MorphoSys Research Site	Buffalo	New York
United States	MorphoSys Research Site	Canton	Ohio
United States	MorphoSys Research Site	Chattanooga	Tennessee
United States	MorphoSys Research Site	Cincinnati	Ohio
United States	MorphoSys Research Site	Clovis	California
United States	MorphoSys Research Site	Columbia	Maryland
United States	MorphoSys Research Site	Danville	Pennsylvania
United States	MorphoSys Research Site	Daphne	Alabama
United States	MorphoSys Research Site	Denison	Texas
United States	MorphoSys Research Site	Detroit	Michigan
United States	MorphoSys Research Site	Eugene	Oregon
United States	MorphoSys Research Site	Florham Park	New Jersey
United States	MorphoSys Research Site	Fort Worth	Texas
United States	MorphoSys Research Site	Fullerton	California
United States	MorphoSys Research Site	Gainesville	Virginia
United States	MorphoSys Research Site	Germantown	Tennessee
United States	MorphoSys Research Site	Harbor City	California
United States	MorphoSys Research Site	Honolulu	Hawaii
United States	MorphoSys Research Site	Houston	Texas
United States	MorphoSys Research Site	Jacksonville	Florida
United States	MorphoSys Research Site	Kansas City	Missouri
United States	MorphoSys Research Site	Lebanon	New Hampshire
United States	MorphoSys Research Site	Lexington	Kentucky
United States	MorphoSys Research Site	Los Angeles	California
United States	MorphoSys Research Site	Louisville	Kentucky
United States	MorphoSys Research Site	Marshfield	Wisconsin
United States	MorphoSys Research Site	McAllen	Texas
United States	MorphoSys Research Site	Minneapolis	Minnesota
United States	MorphoSys Research Site	Nashville	Tennessee
United States	MorphoSys Research Site	Ogden	Utah
United States	MorphoSys Research Site	Olympia	Washington
United States	MorphoSys Research Site	Roanoke	Virginia
United States	MorphoSys Research Site	Rochester	New York
United States	MorphoSys Research Site	Rochester	Minnesota
United States	MorphoSys Research Site	Salt Lake City	Utah
United States	MorphoSys Research Site	San Diego	California
United States	MorphoSys Research Site	Tacoma	Washington
United States	MorphoSys Research Site	Tyler	Texas
United States	MorphoSys Research Site	Virginia Beach	Virginia
United States	MorphoSys Research Site	Whittier	California
United States	MorphoSys Research Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
MorphoSys AG

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Canada,  Colombia,  Czechia,  France,  Germany,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  New Zealand,  Philippines,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  Spain,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS-INV	Progression-Free Survival as assessed by the investigator using the Lugano Response Criteria for Malignant Lymphoma	Time from date of randomization until Progressive Disease or death from any cause. In this trial, the primary endpoint is PFS as assessed by the investigator (up to 43 months)
Secondary	EFS-INV	Event-Free Survival as assessed by the investigator using the Lugano Response Criteria for Malignant Lymphoma	From randomization until the first occurrence of disease progression or relapse as assessed by the INV using, start of new anti-lymphoma treatment or death from any cause, whichever occurs first (up to 43 months)
Secondary	OS	Overall Survival	From randomization until the date of death from any cause (up to 62 months)
Secondary	Metabolic PET-negative CR-rate at EOT by BIRC	Metabolic PET-negative CR rate defined as the proportion of patients who achieved metabolic PET-negative CR as per Lugano 2014 criteria based on PET/CTs performed at the end of the treatment by BIRC	End of treatment, 4-8 weeks after last dose
Secondary	Metabolic PET-negative CR-rate at EOT by INV	Metabolic PET-negative CR rate defined as the proportion of patients who achieved metabolic PET-negative CR as per Lugano 2014 criteria based on PET/CTs performed at the end of the treatment by the investigator	End of treatment, 4-8 weeks after last dose
Secondary	ORR as per INV at EOT	Overall response rate defined as the proportion of patients with CR or PR as per Lugano 2014 criteria based on assessment at the end of the treatment by the INV	6 ± 2 weeks after End of Treatment
Secondary	Time to next anti-lymphoma treatment (TTNT)	TTNT is defined as the time from randomization date to start of next anti-lymphoma therapy (for any reason including disease progression, treatment toxicity, and patient preference) or death due to any cause, whatever comes first.	From randomization date to start of next anti-lymphoma therapy (for any reason including disease progression, treatment toxicity, and patient preference) or death due to any cause, whatever comes first (up to 43 months)
Secondary	Duration of Complete Response (CR) as assessed by the investigator	Duration of CR is defined as the time from the date of the first occurrence of a documented CR, to the date of progression, relapse, or death from any cause, whichever is earlier for the subgroup of patients with a Best Overall Response (BOR) of CR.	From the date of the first occurrence of a documented CR, to the date of progression, relapse, or death from any cause, whichever is earlier (up to 43 months)
Secondary	EFS at 3 years	Event-Free Survival as assessed by the investigator	36 months after randomization
Secondary	PFS at 3 years	Progression-Free Survival as assessed by the investigator	36 months after randomization
Secondary	OS at 3 years	Overall Survival	36 months after randomization