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Alkylating agents

Glofitamab + Chemotherapy for Non-Hodgkin's Lymphoma

Phase 1
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be a candidate for high-dose chemotherapy followed by ASCT or CAR-T therapy
Histologically confirmed B-cell lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights

Study Summary

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

Who is the study for?
This trial is for people with a type of cancer called diffuse large B-cell lymphoma that has come back or didn't respond after their first treatment. They must have had therapy before that included an anti-CD20 antibody and anthracycline, be healthy enough to consider more intense treatments like stem cell transplant or CAR-T therapy, and not have certain medical conditions.Check my eligibility
What is being tested?
Researchers are testing how well Glofitamab works when given with Rituximab plus Ifosfamide, Carboplatin, and Etoposide in patients whose cancer returned or resisted the first line of treatment. The study will look at the drug's effects on the body and its safety.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion of these drugs, blood disorders, increased risk of infections due to weakened immune system, organ inflammation from immune responses, fatigue, nausea, neuropathy (nerve problems), and liver issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am eligible for intense chemotherapy followed by stem cell or CAR-T therapy.
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My cancer is a type of B-cell lymphoma confirmed by lab tests.
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I am fully active or can carry out light work.
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My cancer came back or didn't respond after my first chemoimmunotherapy.
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I have had one treatment that included rituximab and an anthracycline.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
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
Duration of Response (DOR)
Duration of complete response (DOCR)
+9 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: R/R DLBCLExperimental Treatment7 Interventions
Participants will receive up to 3 21-day cycles of glofitamab, rituximab, ifosfamide, carboplatin, and etoposide (glofit-R-ICE).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glofitamab
2021
Completed Phase 1
~60
Obinutuzumab
2015
Completed Phase 3
~3250
Tocilizumab
2012
Completed Phase 4
~1840
Rituximab
1999
Completed Phase 4
~1880
Ifosfamide
2010
Completed Phase 4
~2980
Carboplatin
2014
Completed Phase 3
~6670
Etoposide
2010
Completed Phase 3
~2440

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,427 Previous Clinical Trials
1,089,111 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
888,539 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05364424 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: R/R DLBCL
Non-Hodgkin's Lymphoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05364424 — Phase 1
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05364424 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~14 spots leftby Dec 2024