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R/R DLBCL for Non-Hodgkin's Lymphoma

Tulane Medical Center; Investigational/Research Pharmacy, New Orleans, LA
Non-Hodgkin's LymphomaRituximab - Drug
Eligibility
18+
All Sexes

Study Summary

This trialevaluates a new combination treatment for people with DLBCL that have failed a prior line of therapy.

Eligible Conditions
  • Non-Hodgkin's Lymphoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

1 Primary · 12 Secondary · Reporting Duration: Up to 2.5 years

Year 5
Percentage of participants with anti-drug antibodies (ADAs)
Year 5
Overall survival (OS) after enrollment
Year 5
Progression-free survival (PFS) after enrollment
Year 5
Event-free survival (EFS) after enrollment
Year 5
Duration of complete response (DOCR)
Year 5
Duration of Response (DOR)
Up to 2.5 years
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
Maximum serum concentration (Cmax) of glofitamab
Minimum serum concentration (Cmin) of glofitamab
Mobilization-adjusted response rate (MARR)
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
Percentage of participants with adverse events (AEs)
Percentage of participants with cytokine release syndrome (CRS)

Trial Safety

Phase-Based Safety

1 of 3

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1
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1
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

R/R DLBCL
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: R/R DLBCL · No Placebo Group · Phase 1

R/R DLBCLExperimental Group · 7 Interventions: Rituximab, Glofitamab, Obinutuzumab, Carboplatin, Tocilizumab, Etoposide, Ifosfamide · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Glofitamab
2020
Completed Phase 1
~30
Obinutuzumab
2014
Completed Phase 3
~3250
Carboplatin
2014
Completed Phase 3
~6500
Tocilizumab
2012
Completed Phase 4
~1840
Etoposide
2010
Completed Phase 3
~2380
Ifosfamide
2010
Completed Phase 4
~1580

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2.5 years

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,388 Previous Clinical Trials
1,073,181 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,169 Previous Clinical Trials
881,035 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You need to receive high-dose chemotherapy followed by a stem cell transplant or CAR-T therapy.
References

Frequently Asked Questions

What is the current cohort size of this research endeavor?

"The trial's sponsor, Hoffmann-La Roche, requires 40 patients that meet their inclusion criteria. These patients will be recruited from the New York University Langone Medical Center and UMASS Memorial Medical Center in Worcester." - Anonymous Online Contributor

Unverified Answer

What risks come with the progression of relapsed or refractory diffuse large B-cell lymphoma?

"The safety of R/R DLBCL has been assessed at a score of 1, as this is an early stage clinical trial with only restricted data that supports its efficacy and security." - Anonymous Online Contributor

Unverified Answer

Are participants being recruited to take part in this experiment?

"Clinicaltrials.gov indicates that this research study is actively recruiting participants; the trial was published on November 4th 2022 and revised for accuracy most recently on November 16th of the same year." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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