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Diffuse Large B-Cell Lymphoma (DLBCL)Phase 1NCT05364424

A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Participants With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma

A Phase 1 study testing Glofitamab, Obinutuzumab and Tocilizumab in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Hoffmann-La Roche at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the preliminary efficacy, safety, and pharmacokinetics of glofitamab (glofit) in combination with rituximab plus ifosfamide, carboplatin, and etoposide (R-ICE) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have failed one prior… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-Cell Lymphoma (DLBCL)
What is being tested?
Glofitamab, Obinutuzumab and Tocilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
9 sitesUnited States
Study dates
4 Nov 2022to 15 Oct 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Life expectancy ≥ 12 weeks
  • Histologically confirmed B-cell lymphoma
  • One line of prior systemic therapy including an anti-CD20 monoclonal antibody (i.e. rituximab) and an anthracycline
  • Relapsed or refractory disease after first-line chemoimmunotherapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Participant must be a candidate for high-dose chemotherapy followed by ASCT or CAR-T therapy

Who cannot join

  • Treatment with more than one prior line of therapy for DLBCL
  • Primary mediastinal B-cell lymphoma
  • Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
  • Peripheral neuropathy assessed to be Grade > 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 at enrollment
  • Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment
  • Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment
Show all 20Show fewer
  • Primary or secondary CNS lymphoma at the time of enrollment or history of CNS lymphoma
  • Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
  • Known history of progressive multifocal leukoencephalopathy
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better (with the exception of alopecia and anorexia, or as otherwise permitted by inclusion criteria)
  • Prior solid organ transplantation
  • Prior allogeneic stem cell transplant
  • Prior ASCT for lymphoma
  • Prior autologous stem cell transplant for any indication other than lymphoma, within 5 years from the start of study treatment
  • Active autoimmune disease requiring treatment
  • Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), within 4 weeks prior to first dose of study treatment
  • Ongoing corticosteroid use > 30 mg/day of prednisone or equivalent. Participants who received corticosteroid treatment with ≤ 30 mg/day of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks' duration prior to Cycle 1 Day 1. Participants may have received a brief (≤ 7 days) course of systemic steroids (≤ 100 mg prednisone equivalent per day) prior to initiation of study therapy for control of lymphoma-related symptoms
  • Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
  • Clinically significant history of cirrhotic liver disease

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • The University of Chicago

    Chicago, Illinois, 60637

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Tulane Medical Center

    New Orleans, Louisiana, 70112

  • New York University Langone Medical Center

    New York, New York, 10016

  • Chao Family Comprehensive Cancer Center UCI

    Orange, California, 92868

  • Memorial Cancer Institute at Memorial West

    Pembroke Pines, Florida, 33028

  • UMASS Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: A Phase IB, Open-Label, Multicenter, Single Arm Study Evaluating the Preliminary Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Patients With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma

The purpose of this study is to evaluate the preliminary efficacy, safety, and pharmacokinetics of glofitamab (glofit) in combination with rituximab plus ifosfamide, carboplatin, and etoposide (R-ICE) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have failed one prior line of therapy incorporating an anti-cluster of differentiation (CD) 20 antibody (i.e., rituximab) and an anthracycline, and who are transplant or chimeric antigen receptor T-cell (CAR-T) therapy eligible, defined as being medically eligible for intensive platinum-based salvage therapy followed by autologous stem cell transplantation (ASCT) or for CAR-T therapy.

Being tested
Glofitamab, Obinutuzumab, Tocilizumab, Rituximab, Ifosfamide
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlofitamabDrug

    Participants will receive intravenous (IV) glofitamab for up to 3 cycles.

  • ObinutuzumabDrug

    Participants will receive IV obinutuzumab on Cycle 1 Day 1.

  • TocilizumabDrug

    Participants will receive IV tocilizumab as necessary to manage cytokine release syndrome (CRS) events.

  • RituximabDrug

    Participants will receive up to 2 doses of IV rituximab.

  • IfosfamideDrug

    Participants will receive IV ifosfamide for up to 3 cycles.

  • CarboplatinDrug

    Participants will receive IV carboplatin for up to 3 cycles.

  • EtoposideDrug

    Participants will receive IV etoposide for up to 3 cycles.

Study groups in NCT05364424
Study groupRoleWhat they receive
R/R DLBCLExperimentalParticipants will receive up to 3 21-day cycles of glofitamab, rituximab, ifosfamide, carboplatin, and etoposide (glofit-R-ICE).
Receives: Drug: Glofitamab; Drug: Obinutuzumab; Drug: Tocilizumab; Drug: Rituximab; Drug: Ifosfamide; Drug: Carboplatin; Drug: Etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR), defined as the proportion of participants that achieves a CR or PR within three cycles of glofit-R-ICE, as determined by the investigator according to Lugano criteria

    Measured: Up to 2.5 years

Secondary outcomes (12)

  1. Event-free survival (EFS) after enrollment

    Measured: From enrollment to the first occurrence of disease progression, initiation of new anti-lymphoma therapy (not including planned ASCT or CAR-T therapy), or death from any cause (whichever occurs first) (up to 2.5 years)

  2. Progression-free survival (PFS) after enrollment

    Measured: From enrollment to the first occurrence of disease progression or death from any cause (whichever occurs first) as determined by the investigator according to Lugano criteria (up to 2.5 years)

  3. Mobilization-adjusted response rate (MARR)

    The proportion of participants treated with intent to proceed to ASCT that achieves a CR or PR within three cycles of glofit-R-ICE, as determined by the investigator according to Lugano criteria, and additionally achieves mobilization of a minimum of 2,000,000 CD34+ hematopoietic stem cells/kg for ASCT

    Measured: Up to 2.5 years

  4. Overall survival (OS) after enrollment

    Measured: From enrollment to death from any cause (up to 2.5 years)

  5. CR rate after enrollment, defined as the proportion of participants that achieves a CR within three cycles of glofit-R-ICE, as determined by the investigator according to Lugano criteria

    Measured: Up to 2.5 years

  6. Duration of Response (DOR)

    Measured: From the first occurrence of a documented objective response (CR or PR) to disease progression or death from any cause (whichever occurs first) as determined by the investigator according to Lugano criteria (up to 2.5 years)

  7. Duration of complete response (DOCR)

    Measured: From the first occurrence of a documented complete response to disease progression or death from any cause (whichever occurs first) as determined by the investigator according to Lugano criteria (up to 2.5 years)

  8. Percentage of participants with adverse events (AEs)

    Measured: Up to 2.5 years

  9. Percentage of participants with cytokine release syndrome (CRS)

    Measured: Up to 2.5 years

  10. Maximum serum concentration (Cmax) of glofitamab

    Measured: Up to 2.5 years

  11. Minimum serum concentration (Cmin) of glofitamab

    Measured: Up to 2.5 years

  12. Percentage of participants with anti-drug antibodies (ADAs)

    Measured: From baseline up to 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2022
  2. Study start4 Nov 2022
  3. Primary completion15 Oct 2025
  4. Study completion15 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05364424
Sponsor's protocol ID
GO43693
Status last verified
Nov 2025
First submitted
3 May 2022
Last updated
1 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Glofitamab, Obinutuzumab and Tocilizumab in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Hoffmann-La Roche at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR), defined as the proportion of participants that achieves a CR or PR within three cycles of glofit-R-ICE, as determined by the investigator according to Lugano criteria (time frame: Up to 2.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05364424.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.

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