A Study to Compare the Efficacy and Safety of Glofitamab as a Single Agent Versus Investigator’s Choice in Patients with Relapsed/Refractory Mantle Cell Lymphoma

Start 20 Nov 2023 · Status Ongoing, recruiting · 4 EU/EEA countries · 17 sites · Protocol GO43878

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruiting

Participants planned 176

Countries 4

Sites 17

Mantle Cell Lymphoma (MCL)

To evaluate the efficacy of glofitamab monotherapy compared with an investigator’s choice of bendamustine with rituximab (BR) or lenalidomide with rituximab (R-Len) with respect to progression-free survival (PFS)

Key facts

Sponsor: F. Hoffmann-La Roche AG
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04], Health Care [N] - Environment and Public Health [N06]
Trial duration: 20 Nov 2023 → ongoing
Decision date (initial): 2023-10-04
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: F. Hoffmann-La Roche AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Pharmacokinetic, Efficacy, Safety

Secondary objectives 7

To evaluate the efficacy of glofitamab monotherapy compared with an investigator’s choice of BR or R-Len with respect to complete response (CR) rate, objective response rate (ORR), overall survival (OS)
To evaluate the health-related quality of life of participants treated with glofitamab monotherapy compared with an investigator’s choice of BR or R-Len
To evaluate the efficacy of glofitamab monotherapy compared with an investigator’s choice of BR or R-Len on the basis of investigator-assessed PFS, investigator-assessed CR rate, investigator-assessed ORR, investigator-assessed DOCR, investigator-assessed DOR, BIRC-assessed DOCR, BIRC-assessed DOR and investigator-assessed EFS
To evaluate the safety and tolerability of glofitamab monotherapy compared with an investigator’s choice of BR or R-Len
To evaluate the health-related quality of life of participants treated with glofitamab monotherapy compared with an investigator’s choice of BR or R-Len on the basis of time to deterioration in lymphoma symptoms as well as proportion of participants experiencing clinically meaningful improvement in physical functioning and / or fatigue
To characterize glofitamab pharmacokinetic (PK) profile in participants with MCL
To evaluate the immune response to glofitamab

Conditions and MedDRA coding

Mantle Cell Lymphoma (MCL)

Version	Level	Code	Term	System organ class
21.0	PT	10026800	Mantle cell lymphoma recurrent	100000004864
21.1	PT	10026801	Mantle cell lymphoma refractory	100000004864

Study design 3 periods

#	Title	Allocation	Blinding	Arms
1	Stratification Participants will be stratified by the following factors at the time of randomization: - Number of prior lines of therapy (1 or 2 or more prior lines of therapy) - Outcome of last line of therapy (relapse vs refractory disease)	Randomised Controlled	None
2	Pretreatment Two obinutuzumab 1000 mg pretreatments will be administered by IV infusion as an absolute (flat) dose of 2000 mg from Day 1 of Cycle 1 for all participants. The first 1000 mg dose must commence on Day 1; optionally the second 1000 mg dose may be given on Cycle 1, but must be given at least before glofitamab.	Randomised Controlled	None
3	Treatment Eligible participants of age ≥18 years will be randomized in a 1:1 ratio to receive either glofitamab as a single agent or an investigator’s choice between BR or R-Len. Approximately half of the patients on the control arm will receive BR therapy, the remaining patients will receive R-Len.	Randomised Controlled	None	Control Arm: The control arm will consist of the administration of BR, or R-Len Glofitamab Arm: Glofitamab will be administered on a step-up dosing schedule starting on Day 8 of Cycle 1 (2.5 mg), Day 15 of Cycle 1 (10 mg), followed by 30 mg on Day 1 of Cycles 2−12, with each cycle being 21 days (i.e., every 3 weeks).

Regulatory references

Scientific advice from competent authorities: European Medicines Agency
EMA paediatric investigation plan (PIP): EMEA-002648-PIP01-09
Plan to share IPD: No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

PET-positive disease at screening (Deauville score of 4 or 5) according to the “Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification” with at least one target FDG-avid lesion In rare cases of non-FDG-avid MCL with at least one measurable lesion located in an area suitable for biopsy, such as the gastrointestinal tract and a biopsy can be obtained to confirm a histological diagnosis, a participant may be eligible
Histologically-confirmed MCL, demonstrating either overexpression of cyclin D1 or the presence of t(11:14) within 12 months of study entry
Relapsed or refractory disease
At least one (>= 1) line of prior systemic therapy: - Inclusion of BTK inhibitor Prior therapy must have included a BTK inhibitor plus another systemic therapy option (e.g., a regimen containing a CD20 monoclonal antibody, prior chemotherapy, targeted agent therapy such as bortezomib, etc.) – Progression or Relapse: Participants must have progressed or relapsed at any time on BTK inhibitor therapy, or failed to achieve a partial response (PR) within 12 weeks of BTK inhibitor therapy – Exclusion of BTK Inhibitor Intolerance: Participants intolerant to BTK inhibitor therapy who are unable to complete at least 12 weeks of BTK inhibitor therapy should be excluded – Local Therapies: Local therapies (e.g., radiotherapy) will not be considered as lines of therapy
Adequate renal function, defined as an estimated creatinine clearance ≥ 30 mL/min
Adequate hematologic function

Exclusion criteria 7

History of other malignancy that could affect compliance with the protocol or interpretation of results - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the compliance of or safety or efficacy assessment of the investigational regimen are eligible for this study
Leukemic, non-nodal MCL
Prior solid organ transplantation, prior allogeneic stem cell transplant
Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3 and also treatment with chimeric antigen receptor T-cell (CAR-T) cell therapy
Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma
Presence of severe active bacterial, viral, fungal, mycobacterial, parasitic, or other infections at the time of study enrolment. Participants must have recovered from any severe or potentially serious infection (as assessed by the investigator) at least 2 weeks before the first study treatment
Clinically significant history of cirrhotic liver disease

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

PFS as determined by the Blinded independent Review Committee (BIRC)

Secondary endpoints 23

BIRC-assessed CR rate
BIRC-assessed ORR
OS
Time to deterioration in physical functioning and fatigue as assessed by the European Organization for Research and Treatment of Cancer (EORTC) quality of life (QoL)-C30
Investigator-assessed PFS
Investigator-assessed CR rate
Investigator-assessed OR rate
Investigator-assessed DOCR
Investigator-assessed DOR
BIRC-assessed DOCR
BIRC-assessed DOR
Investigator-assessed EFS
Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 grading scale, except cytokine-release syndrome (CRS), immune effector cell associated neurotoxicity syndrome (ICANS) and hemophagocytic lymphohistiocytosis (HLH) which will be graded using American Society for Transplantation and Cellular Therapy (ASTCT) grading criteria (Lee et al., 2019; Hines et al., 2023
Change from baseline in selected vital signs
Change from baseline in selected clinical laboratory test results
Frequency, severity, and interference of side effects as assessed by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Proportion of participants reporting each response option for item General Population, Question 5 (GP5) from the Functional Assessment of Cancer Therapy General (FACT-G) at each assessment timepoint by treatment arm
Time to deterioration in lymphoma symptoms, defined as the time from randomization to the first documentation of a 3-point or more decrease in score as assessed by the Functional Assessment of Cancer Therapy Lymphoma Lymphoma Subscale (FACT-Lym LYMS) questionnaire
Proportion of participants experiencing a clinically meaningful improvement (3-point or more increase) in lymphoma symptoms as assessed through use of the FACT-Lym LYMS
Proportion of participants experiencing a clinically meaningful improvement in physical functioning (10-point or more increase) and/or fatigue (10-point or more decrease) as assessed by the EORTC QLQ-C30
Change from baseline in physical functioning, fatigue, and lymphoma symptoms at each cycle as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and FACT-Lym LYMS
Serum concentration of glofitamab at specified timepoints
Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

RoActemra 20 mg/mL concentrate for solution for infusion

PRD2154622 · Product

Active substance: Tocilizumab
Substance synonyms: RO4877533, ATLIZUMAB, TOCILIZUMABUM
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: IV INFUSION
Max daily dose: 8 mg/Kg milligram(s)/kilogram
Max total dose: 800 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: L04AC07 — -
Marketing authorisation: EU/1/08/492/003
MA holder: ROCHE REGISTRATION GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Label modified for clinical trial use

RoActemra 20 mg/mL concentrate for solution for infusion

PRD2154623 · Product

Active substance: Tocilizumab
Substance synonyms: RO4877533, ATLIZUMAB, TOCILIZUMABUM
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: IV INFUSION
Max daily dose: 8 mg/Kg milligram(s)/kilogram
Max total dose: 800 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: L04AC07 — -
Marketing authorisation: EU/1/08/492/004
MA holder: ROCHE REGISTRATION GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Label modified for clinical trial use

Gazyvaro 1,000 mg concentrate for solution for infusion.

PRD2154738 · Product

Active substance: Obinutuzumab
Substance synonyms: RO5072759, AFUTUZUMAB, RO-5072759, RG-7159, GA-101, RO 5072759
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: IV INFUSION
Max daily dose: 1000 mg milligram(s)
Max total dose: 2000 mg milligram(s)
Max treatment duration: 2 Day(s)
Authorisation status: Authorised
ATC code: L01XC15 — -
Marketing authorisation: EU/1/14/937/001
MA holder: ROCHE REGISTRATION GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/15/1504
Modified vs. Marketing Authorisation: Yes
Modification description: Label modified for clinical trial use

Glofitamab

PRD9870862 · Product

Active substance: Glofitamab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: IV INFUSION
Max daily dose: 30 mg milligram(s)
Max total dose: 342.5 mg milligram(s)
Max treatment duration: 252 Day(s)
Authorisation status: Not Authorised
MA holder: F. HOFFMANN-LA ROCHE LTD
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/21/2497

Columvi 10 mg concentrate for solution for infusion

PRD10561232 · Product

Active substance: Glofitamab
Substance synonyms: ANTI-CD20/CD3 BISPECIFIC MONOCLONAL ANTIBODY RO7082859, RO-7082859, RG-6026, RO7082859
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: IV INFUSION
Max daily dose: 30 mg milligram(s)
Max total dose: 342.5 mg milligram(s)
Max treatment duration: 252 Day(s)
Authorisation status: Authorised
ATC code: NOTASSIGN — -
Marketing authorisation: EU/1/23/1742/002
MA holder: ROCHE REGISTRATION GMBH
MA country: Norway
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Re-labeled and re packaged for Clinical Trial Use

Comparator 8

Bendamustin Baxter 2,5 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

PRD7977086 · Product

Active substance: Bendamustine Hydrochloride
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: IV INFUSION
Max daily dose: 90 mg/m2 milligram(s)/sq. meter
Max total dose: 1080 mg/m2 milligram(s)/sq. meter
Max treatment duration: 168 Day(s)
Authorisation status: Authorised
ATC code: L01AA09 — -
Marketing authorisation: 2200126.00.00
MA holder: BAXTER ONCOLOGY GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Label modified for clinical trial use

Bendamustin cell pharm® 2,5 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

PRD3489660 · Product

Active substance: Bendamustine Hydrochloride
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: IV INFUSION
Max daily dose: 90 mg/m2 milligram(s)/sq. meter
Max total dose: 1080 mg/m2 milligram(s)/sq. meter
Max treatment duration: 168 Day(s)
Authorisation status: Authorised
ATC code: L01AA09 — -
Marketing authorisation: 95676.00.00
MA holder: STADAPHARM GMBH
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Label modified for clinical trial use

Bendamustin Hikma 2,5 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

PRD7979464 · Product

Active substance: Bendamustine Hydrochloride
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: IV INFUSION
Max daily dose: 90 mg/m2 milligram(s)/sq. meter
Max total dose: 1080 mg/m2 milligram(s)/sq. meter
Max treatment duration: 168 Day(s)
Authorisation status: Authorised
ATC code: L01AA09 — -
Marketing authorisation: 2202335.00.00
MA holder: HIKMA FARMACÊUTICA (PORTUGAL), S.A.
MA country: Germany
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Label modified for clinical trial use

Lenalidomide Accord 5 mg hard capsules

PRD6773394 · Product

Active substance: Lenalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 20 mg milligram(s)
Max total dose: 5040 mg milligram(s)
Max treatment duration: 252 Day(s)
Authorisation status: Authorised
ATC code: L04AX04 — -
Marketing authorisation: EU/1/18/1316/004
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Label modified for clinical trial use

Lenalidomide Accord 15 mg hard capsules

PRD6773399 · Product

Active substance: Lenalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 20 mg milligram(s)
Max total dose: 5040 mg milligram(s)
Max treatment duration: 252 Day(s)
Authorisation status: Authorised
ATC code: L04AX04 — -
Marketing authorisation: EU/1/18/1316/009
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Label modified for clinical trial use

Lenalidomide Accord 10 mg hard capsules

PRD6773397 · Product

Active substance: Lenalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 20 mg milligram(s)
Max total dose: 5040 mg milligram(s)
Max treatment duration: 252 Day(s)
Authorisation status: Authorised
ATC code: L04AX04 — -
Marketing authorisation: EU/1/18/1316/007
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Label modified for clinical trial use

Lenalidomide Accord 20 mg hard capsules

PRD6773400 · Product

Active substance: Lenalidomide
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 20 mg milligram(s)
Max total dose: 5040 mg milligram(s)
Max treatment duration: 252 Day(s)
Authorisation status: Authorised
ATC code: L04AX04 — -
Marketing authorisation: EU/1/18/1316/010
MA holder: ACCORD HEALTHCARE S.L.U.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

MabThera 500 mg concentrate for solution for infusion

PRD2154043 · Product

Active substance: Rituximab
Substance synonyms: CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: IV INFUSION
Max daily dose: 375 mg/m2 milligram(s)/sq. meter
Max total dose: 2625 mg/m2 milligram(s)/sq. meter
Max treatment duration: 252 Day(s)
Authorisation status: Authorised
ATC code: L01XC02 — RITUXIMAB
Marketing authorisation: EU/1/98/067/002
MA holder: ROCHE REGISTRATION GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Label modified for clinical trial use

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation: F. Hoffmann-La Roche AG
Address: Grenzacherstrasse 124
City: Basel
Postcode: 4058
Country: Switzerland

Scientific contact point

Organisation: F. Hoffmann-La Roche AG
Contact name: Trial Information System - TISL

Public contact point

Organisation: F. Hoffmann-La Roche AG
Contact name: Trial Information System - TISL

Third parties 10

Organisation	City, country	Duties
Bioclinica Inc. ORG-100033079	Princeton, United States	Other
Almac Clinical Technologies LLC ORG-100043036	Souderton, United States	Interactive response technologies (IRT)
Greenphire LLC ORG-100041621	King Of Prussia, United States	Other
IQVIA Limited ORG-100008655	Reading, United Kingdom	On site monitoring
QPS Netherlands B.V. ORG-100009393	Groningen, Netherlands	Other
Medidata Solutions Inc. ORG-100016256	New York, United States	Other
CellCarta ORG-100039881	Antwerp, Belgium	Other
Pharmaceutical Product Development LLC ORG-100016999	Richmond, United States	Other
Labcorp Central Laboratory Services S.a.r.l. ORG-100011524	Meyrin, Switzerland	Other
WCG Clinical Inc. ORG-100040730	Princeton, United States	Other

Locations

4 EU/EEA countries · 17 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Ongoing, recruiting	10	5
Italy	Ongoing, recruiting	10	5
Spain	Ongoing, recruiting	12	5
Sweden	Ongoing, recruiting	7	2
Rest of world Canada, Brazil, China, Taiwan, United States, Australia, Korea, Republic of, United Kingdom	—	137	—

Investigational sites

France

5 sites · Ongoing, recruiting

Hopital Huriez

Service des Maladies du sang, 1 Place De Verdun, 59045, Lille Cedex

Institut Curie

Département d’hématologie, 35 Rue Dailly, 92210, Saint-Cloud

Hopital Saint Eloi

Service d’Hématologie clinique, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5

Hopital Necker Enfants Malades

Service d’Hématologie Adultes, 149 Rue De Sevres, 75015, Paris

Hospital Hotel Dieu

Service d’Hématologie clinique, 1 Place Alexis Ricordeau, 44000, Nantes

Italy

5 sites · Ongoing, recruiting

Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria

SCDU Ematologia, Via Venezia 16, 15121, Alexandria

Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino

Divisione Universitaria di Ematologia, Corso Bramante 88, 10126, Turin

European Institute Of Oncology S.r.l.

Dipartimento di Oncoematologia, Via Giuseppe Ripamonti 435, 20141, Milan

Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico

UOC Ematologia, Via Pietro Albertoni 15, 40138, Bologna

Cliniche Gavazzeni S.p.A.

Unità di Oncoematologia, Via Mauro Gavazzeni 21, 24125, Bergamo

Spain

5 sites · Ongoing, recruiting

Hospital Clinic De Barcelona

Hematology, Calle Villarroel 170, 08036, Barcelona

Hospital General Universitario Morales Meseguer

Hematology, Avenida Del Marques De Los Velez S/n, 30008, Murcia

Complexo Hospitalario Universitario A Coruna

Hematology, Lugar Jubias De Arriba 84, 15006, A Coruna

Hospital Universitari Vall D Hebron

Hematology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona

Hospital Universitario Puerta Del Mar

Hematology, Avenida De Ana De Viya 21, 11009, Cadiz

Sweden

2 sites · Ongoing, recruiting

Region Skane Skanes Universitetssjukhus

Onkologi och Strålningsfysik, Entregatan 7, Lunds Allhelgonafors, Lund

Uppsala University Hospital

Blod- & Tumörsjukdomar, Akademiska Sjukhuset, 751 85, Uppsala

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Recruitment start
France	2024-01-05	2024-03-04
Italy	2023-11-20	2024-01-30
Spain	2023-11-29	2023-11-30
Sweden	2024-01-17	2024-03-04

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Unexpected events 1 · Art. 53 CTR

Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.

Unexpected event UE-108489

Event date: 2025-11-10
Date aware: 2025-11-10
Submission date: 2025-12-02
Member states affected: France, Italy, Spain, Sweden
Event description: New important identified risk of Hemophagocytic Lymphohistiocytosis (HLH) has been identified for Glofitamab.

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 97 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol Clarification Letter 2023-503206-37-00 Redacted	NA
Protocol (for publication)	d1_protocol-2023-503206-37-00_redacted	5
Protocol (for publication)	D4_Patient facing documents_EQ-5D-5L_EN	1.2
Protocol (for publication)	D4_Patient facing documents_EQ-5D-5L_ES-ES	1
Protocol (for publication)	D4_Patient facing documents_EQ-5D-5L_FR-FR	1.2
Protocol (for publication)	D4_Patient facing documents_EQ-5D-5L_IT-IT	1.1
Protocol (for publication)	D4_Patient facing documents_EQ-5D-5L_SE-SE	1
Protocol (for publication)	D4_Patient facing documents_FACT-Lym_EN	4
Protocol (for publication)	D4_Patient facing documents_FACT-Lym_ES-ES	4
Protocol (for publication)	D4_Patient facing documents_FACT-Lym_FR-FR	4
Protocol (for publication)	D4_Patient facing documents_FACT-Lym_IT-IT	4
Protocol (for publication)	D4_Patient facing documents_FACT-Lym_SE-SE	4
Protocol (for publication)	D4_Patient facing documents_GP5_EN	4
Protocol (for publication)	D4_Patient facing documents_GP5_ES-ES	4
Protocol (for publication)	D4_Patient facing documents_GP5_FR-FR	4
Protocol (for publication)	D4_Patient facing documents_GP5_IT-IT	4
Protocol (for publication)	D4_Patient facing documents_GP5_SE-SE	4
Protocol (for publication)	D4_Patient facing documents_Patient_Brochure_EN	1
Protocol (for publication)	D4_Patient facing documents_Patient_Brochure_ES-ES	1
Protocol (for publication)	D4_Patient facing documents_Patient_Brochure_FR-FR	1
Protocol (for publication)	D4_Patient facing documents_Patient_Brochure_IT-IT	1
Protocol (for publication)	D4_Patient facing documents_Patient_Diary_EN	1
Protocol (for publication)	D4_Patient facing documents_Patient_Diary_ES-ES	1
Protocol (for publication)	D4_Patient facing documents_Patient_Diary_FR-FR	1
Protocol (for publication)	D4_Patient facing documents_Patient_Diary_IT-IT	1
Protocol (for publication)	D4_Patient facing documents_PRO-CTCAE_EN	1
Protocol (for publication)	D4_Patient facing documents_PRO-CTCAE_ES-ES	1
Protocol (for publication)	D4_Patient facing documents_PRO-CTCAE_FR-FR	1
Protocol (for publication)	D4_Patient facing documents_PRO-CTCAE_IT-IT	1
Protocol (for publication)	D4_Patient facing documents_PRO-CTCAE_SE-SE	1
Protocol (for publication)	D4_Patient facing documents_QLQ-C30_EN	3
Protocol (for publication)	D4_Patient facing documents_QLQ-C30_ES-ES	3
Protocol (for publication)	D4_Patient facing documents_QLQ-C30_FR-FR	3
Protocol (for publication)	D4_Patient facing documents_QLQ-C30_IT-IT	3
Protocol (for publication)	D4_Patient facing documents_QLQ-C30_SE-SE	3
Protocol (for publication)	D4_Patient facing documents_SF-6Dv2_EN	1
Protocol (for publication)	D4_Patient facing documents_SF-6Dv2_ES-ES	1
Protocol (for publication)	D4_Patient facing documents_SF-6Dv2_FR-FR	1
Protocol (for publication)	D4_Patient facing documents_SF-6Dv2_IT-IT	1
Protocol (for publication)	D4_Patient facing documents_SF-6Dv2_SE-SE	1
Protocol (for publication)	D4_Patient facing documents_Treat_Checkists_EN	1
Protocol (for publication)	D4_Patient facing documents_Treat_Checkists_ES-ES	1
Protocol (for publication)	D4_Patient facing documents_Treat_Checkists_FR-FR	1
Protocol (for publication)	D4_Patient facing documents_Treat_Checkists_IT-IT	1
Recruitment arrangements (for publication)	K1_Recruitment Arrangements	1
Recruitment arrangements (for publication)	K1_recruitment arrangements	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1
Recruitment arrangements (for publication)	K2_recruitment material leaftlet	1
Recruitment arrangements (for publication)	K3_Document additionnel_redacted	1
Subject information and informed consent form (for publication)	L1_Privacy sheet other subjects	N/A
Subject information and informed consent form (for publication)	L1_SIS and ICF infant and Privacy sheet_CLEAN	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF main and Appendix 1_redacted	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF pregnant partner and Privacy sheet_CLEAN	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Biosamples	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Consent for Infant Health Data	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Consent for pregnant partner	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Cross Over	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_ICF Appendix 1 (Risks)	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_ICF Appendix 2 (Data integrity)	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_ICF Appendix 3 (optional biopsies)_REDACTED	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_ICF Appendix 4 (consent to long term storage, RBR)	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_ICF Appendix 5 (consent to treatment beyond progression)	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_ICF Appendix 6 (consent to cross-over)	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Infant health	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main ICF_REDACTED	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main research_Redacted	5
Subject information and informed consent form (for publication)	L1_SIS and ICF_Optional biopsy	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnancy	1
Subject information and informed consent form (for publication)	L1_SIS_ICF_General	10
Subject information and informed consent form (for publication)	L1_SIS_ICF_IAF	3
Subject information and informed consent form (for publication)	L1_SIS_ICF_optional biopsy	2
Subject information and informed consent form (for publication)	L1_SIS_ICF_PPA	3
Subject information and informed consent form (for publication)	L1_SIS_ICF_RBR	2
Subject information and informed consent form (for publication)	L2_Other subject information and material_Patient and Caregiver Journey_REDACTED	3.0
Subject information and informed consent form (for publication)	L2_Other subject information and material_Trial Handout_clean	2.0
Subject information and informed consent form (for publication)	L2_Other subject information and material_Trial poster	2.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Patient and Caregiver Journey	4
Subject information and informed consent form (for publication)	L2_Other subject information material_Patient and Caregiver Journey_Redacted	3
Subject information and informed consent form (for publication)	L2_Other Subject Information Material_Patient Card_Clean	4
Subject information and informed consent form (for publication)	L2_Other subject information material_PRO Cover Pages	1
Subject information and informed consent form (for publication)	L2_other subject information material_pt guideline_redacted	3
Subject information and informed consent form (for publication)	L2_other subject information material_pt leaflet	2.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Thank you Letter_Consider participation	1
Subject information and informed consent form (for publication)	L2_Other subject information material_Thank you Letter_Treatment Completion	1
Subject information and informed consent form (for publication)	L2_Other subject information material_Thank you Letter-participation	1
Subject information and informed consent form (for publication)	L2_Other subject information material_Trial handout	2
Subject information and informed consent form (for publication)	L2_Other subject information material_Trial handout_Clean	2
Subject information and informed consent form (for publication)	L2_Other subject information material_Trial poster	2
Subject information and informed consent form (for publication)	L2_Other subject information material_Trial poster_Clean	2
Summary of Product Characteristics (SmPC) (for publication)	e2_smpc lenalidomide	NA
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC Bendamustine	NA
Synopsis of the protocol (for publication)	D1_Protocol synopsis_ENG 2023-503206-37-00	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_ES-ES 2023-503206-37-00	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_FR-FR 2023-503206-37-00	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_IT-IT 2023-503206-37-00	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_SE-SE 2023-503206-37-00	1

Application history

11 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-06-09	Spain	Acceptable 2023-10-02	2023-10-04
2	SUBSTANTIAL MODIFICATION	SM-1	2023-12-19	Spain	Acceptable 2024-02-22	2024-02-22
3	NON SUBSTANTIAL MODIFICATION	NSM-1	2024-06-11	Spain	Acceptable 2024-02-22	2024-06-11
4	NON SUBSTANTIAL MODIFICATION	NSM-2	2024-07-05	Spain	Acceptable 2024-02-22	2024-07-05
5	SUBSTANTIAL MODIFICATION	SM-2	2024-12-09	Spain	Acceptable 2025-03-03	2025-03-03
6	NON SUBSTANTIAL MODIFICATION	NSM-3	2025-03-28	Spain	Acceptable 2025-03-03	2025-03-28
7	SUBSTANTIAL MODIFICATION	SM-3	2025-04-11	Spain	Acceptable 2025-06-16	2025-06-16
8	NON SUBSTANTIAL MODIFICATION	NSM-4	2025-07-31	Spain	Acceptable 2025-06-16	2025-07-31
9	NON SUBSTANTIAL MODIFICATION	NSM-5	2025-08-28	Spain	Acceptable 2025-06-16	2025-08-28
10	SUBSTANTIAL MODIFICATION	SM-4	2025-12-15	Spain	Acceptable 2026-03-02	2026-03-03
11	NON SUBSTANTIAL MODIFICATION	NSM-6	2026-03-17	Spain	Acceptable 2026-03-02	2026-03-17

A Study to Compare the Efficacy and Safety of Glofitamab as a Single Agent Versus Investigator’s Choice in Patients with Relapsed/Refractory Mantle Cell Lymphoma

Overview

Key facts

Trial design

Main objective

Secondary objectives 7

Conditions and MedDRA coding

Study design 3 periods

Regulatory references

Eligibility criteria

Inclusion criteria 6

Exclusion criteria 7

Endpoints

Primary endpoints 1

Secondary endpoints 23

Investigational products

Test 5

Comparator 8

Sponsors and contacts

F. Hoffmann-La Roche AG

Scientific contact point

Public contact point

Third parties 10

Locations

By country

Investigational sites

Country notifications

Oversight and notifications

Unexpected events 1 · Art. 53 CTR

Results and documents

Documents 97 files

Application history

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