Trials Sponsors Conditions Drugs Pricing

Conditions

relapsed/refractory Large B-Cell Lymphoma Relapsed /Refractory DLBCL

Outcome Measures

Primary Outcomes (1)

CRR@EOT
Complete response rate (CRR) at end of treatment (CCR@EOT), defined as proportion of patients who achieved complete response (CR) at the end of trial treatment (EOT) as per Lugano classification
at the end of trial treatment, on average after 10 months

Secondary Outcomes (15)

CCR@pIT and CCR@3MpCT
post induction (after 6 weeks) and 3 months post-CAR-T cell infusion (after 4,5 months)
Overall CRR
from first Investigational Medicinal Product (IMP) administration until end of follow-up, on average 2,5 years
ORR post induction, at 3 months post-CAR-T cell infusion, and at EOT
post induction (after 6 weeks), at 3 months post-CAR-T cell infusion (after 4,5 months), and at end of trial treatment (on average after 10 months)
Overall ORR
from first IMP administration until end of follow-up, on average 2,5 years
Best overall response (BOR) rate
from first IMP administration until end of follow-up, on average 2,5 years
+10 more secondary outcomes

Study Arms (1)

Double-T

EXPERIMENTAL

glofitamab with gemcitabine/oxaliplatin (Glofi-Gem/Ox) prior to and glofitamab monotherapy consolidation after standard of care CAR-T cell therapy

Drug: Glofitamab, Gemcitabine, and Oxaliplatin as Induction TherapyDrug: Glofitamab as Consolidation therapy

Interventions

Glofitamab, Gemcitabine, and Oxaliplatin as Induction TherapyDrug

Induction Therapy before Standard of Care CAR-T Cell therapy

Double-T

Glofitamab as Consolidation therapyDrug

Consolidation with Glofitamab after CAR-T Cell Therapy

Double-T

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Columvi 10 mg concentrate for solution for infusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record
Formulated product
Gazyvaro 1,000 mg concentrate for solution for infusion.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record
Grouped treatment entry
Glofitamab, Gemcitabine, and Oxaliplatin as Induction Therapy
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record
Treatment programme
Glofitamab as Consolidation therapy
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Columvi 10 mg concentrate for solution for infusion
Named ingredient: glofitamab
View registry record
Gazyvaro 1,000 mg concentrate for solution for infusion.
Named ingredient: obinutuzumab
View registry record

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient\* has given written informed consent.
Patient is 18-80 years of age at time of signing the written informed consent

Sponsors & Collaborators

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
Industrylead
Universitätsklinikum Düsseldorf, Germany
Type not reportedcollaborator
Roche Pharma AG

Study Sites (5)

Universitätsklinikum Heidelberg - Innere Medizin V

Heidelberg, Baden-Wurttemberg, 69120, Germany

Peter Dreger, Prof. Dr.CONTACT

Universitätsklinikum Düsseldorf - Klinik für Hämatologie, Onkologie und klinische Immunologie

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Sascha Dietrich, Prof. Dr.CONTACT

Universitätsklinikum Essen (AöR) - Westdeutsches Tumorzentrum Essen - Klinik für Hämatologie und Stammzellltransplantation

Essen, North Rhine-Westphalia, 45147, Germany

Bastian von Tresckow, Prof. Dr.CONTACT

Universitätsklinikum Münster - Medizinische Klinik A

Münster, North Rhine-Westphalia, 48149, Germany

MeSH Terms

Interventions

glofitamabGemcitabineOxaliplatinNeoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic ChemicalsCombined Modality TherapyTherapeutics

Study Officials

Sascha Dietrich, Prof. Dr.
University Düsseldorf
PRINCIPAL INVESTIGATOR
Salah-Eddin Al-Batran, Prof. Dr.
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
STUDY CHAIR

Central Study Contacts

Birte Friedrichs, Dr.

CONTACT

birte.friedrichs@med.uni-duesseldorf.de

Johanna Riedel

CONTACT

double-t@ikf-khnw.de

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 21, 2026

Study Start

April 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

April 2028

Estimated

You may not qualify if:

Patient has HIV infection of any stage as determined by presence of anti-HIV antibodies (confirmatory test) and / or presence of RNA confirmed by PCR during screening
Patient has previous or concurrent malignancies with the following exceptions:
Surgically cured carcinoma in-situ
Other kinds of cancer without evidence of disease for at least 3 years
Patient has known hypersensitivity to any component of the Glofitamab, Obinutuzumab, Yescarta and/or Breyanzi formulation formulation as well as a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion protein and/or any known contraindication (including hypersensitivity) to one of the other trial drugs
Patient has severe active infection requiring iv treatment within 14 days prior first dose of study drugs
Patient has congenital or acquired immunodeficiency including previous organ or allogeneic stem cell transplantation
Patient received prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
Patient received prior treatment with gemcitabine and oxaliplatin in prior lymphoma treatment line
Patient had a major surgery within 4 weeks prior to first dose of study drugs
Patient has primary or secondary central nervous system (CNS) lymphoma at the time of enrollment or history of CNS lymphoma
Patient has current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
Patient has significant or extensive cardiovascular disease such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 3 months, unstable arrhythmias, or unstable angina
Patient has an active autoimmune disease requiring systemic treatment
Patient receives ongoing corticosteroid use \>20 mg/day of prednisone or equivalent. Patients on stable low-dose corticosteroids (≤20 mg/day of prednisone or equivalent for at least 7-14 days prior to first IMP administration) or on short courses of higher-dose corticosteroids that are completed before first IMP administration are eligible.
+7 more criteria

Double-T - Improving Outcomes in High-risk 2nd Line Relapsed/Refractory Large B-Cell Lymphoma Patients Eligible for CAR-T-cell Therapy With a Glofitamab-based Induction and Consolidation Concept

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (1)

Double-T

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (1)

Double-T

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations