← Back to Search

Alkylating agents

Glofitamab Combo for Lymphoma

Phase 1
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for participants with r/r NHL; ECOG performance status 0-3 for participants with untreated DLBCL
Participants must be appropriate for treatment with CHOP and typically should not have been exposed to prior anthracyclines or must not exceed the cumulative lifetime dose of anthracyclines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 29 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug (glofitamab) in combination with other drugs that are already used to treat NHL and DLBCL. The goal is to find the best dose of glofitamab to give with these other drugs, and to see if the combination is safe and has any activity against the cancer.

Who is the study for?
Adults (18+) with Non-Hodgkin's Lymphoma, specifically untreated Diffuse Large B-Cell Lymphoma or those whose disease relapsed/progressed after treatment. Participants must have adequate organ function, no severe infections or recent vaccinations, and not exceed lifetime dose of certain chemotherapies.Check my eligibility
What is being tested?
The trial is testing Glofitamab in combination with other cancer drugs like Rituximab and CHOP chemotherapy in two parts: finding the right dose for relapsed/refractory NHL patients and expanding that dose to untreated DLBCL patients to assess safety and effectiveness.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to monoclonal antibodies, effects from chemotherapy such as nausea, hair loss, increased infection risk, nerve damage risks associated with Polatuzumab Vedotin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have not had anthracycline treatment or have not exceeded the safe lifetime dose.
Select...
I am 18 years old or older.
Select...
My NHL has come back or gotten worse after treatment with R or G.
Select...
I have a type of lymphoma (DLBCL) that has not been treated and is likely to have CD20.
Select...
I have a tumor that can be measured and is larger than 1.5 cm if it's in a lymph node or larger than 1.0 cm if it's outside of lymph nodes.
Select...
Side effects from my previous cancer treatments are mild or gone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 29 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 29 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part I and II: Percentage of Participants with Adverse Events
Part I: Percentage of Participants with Dose Limiting Toxicities (DLTs)
Secondary outcome measures
Change from Baseline in T-cell Activation Markers
Duration of CR
Overall Survival (OS)
+10 more

Side effects data

From 2021 Phase 1 trial • 23 Patients • NCT04313608
41%
Cytokine release syndrome
35%
Diarrhoea
35%
Hypomagnesaemia
35%
Pyrexia
35%
Neuropathy peripheral
35%
Anaemia
24%
Thrombocytopenia
24%
Hypophosphataemia
24%
Liver function test abnormal
24%
Nausea
24%
Neutropenia
24%
Fatigue
24%
Constipation
24%
Platelet count decreased
18%
Headache
18%
Sepsis
18%
Neutrophil count decreased
18%
Arthralgia
18%
Peripheral sensory neuropathy
18%
Hypokalaemia
18%
Oral candidiasis
18%
Weight decreased
18%
Lethargy
12%
Flushing
12%
Superficial vein thrombosis
12%
Paraesthesia
12%
Blood alkaline phosphatase increased
12%
Abdominal pain
12%
Dizziness
12%
Abdominal discomfort
12%
Colitis
12%
Vomiting
12%
Rectal haemorrhage
12%
Gastrooesophageal reflux disease
12%
Pain in extremity
12%
Infusion related reaction
12%
Alanine aminotransferase increased
12%
Cough
6%
Rash
6%
Upper respiratory tract infection
6%
Cytomegalovirus infection reactivation
6%
Thrombosis
6%
Rash maculo-papular
6%
Pain in jaw
6%
Orthostatic hypotension
6%
Squamous cell carcinoma
6%
Vision blurred
6%
Abdominal distension
6%
Abdominal tenderness
6%
Tumour lysis syndrome
6%
Back pain
6%
Hypocalcaemia
6%
Hypertension
6%
Cellulitis
6%
Neutropenic sepsis
6%
Transient ischaemic attack
6%
Chest pain
6%
Aspartate aminotransferase increased
6%
Blood creatinine increased
6%
Adenocarcinoma
6%
Oropharyngeal pain
6%
Groin pain
6%
Abdominal pain lower
6%
Anal haemorrhage
6%
Performance status decreased
6%
Hypogammaglobulinaemia
6%
Seasonal allergy
6%
Urinary tract infection
6%
Gamma-glutamyltransferase increased
6%
Hyperlipidaemia
6%
External ear cellulitis
6%
Decreased appetite
6%
Hyperglycaemia
6%
Epistaxis
6%
Depression
6%
Photosensitivity reaction
6%
Injury
6%
Wound infection
6%
Hypoalbuminaemia
6%
Dyspnoea exertional
6%
Intention tremor
6%
Throat irritation
6%
Vasospasm
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Glofit-GemOx
Arm B: Mosun-GemOx

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 2: DLBCL Pola-R-CHPExperimental Treatment7 Interventions
Participants with untreated DLBCL will receive Pola-R-CHP + glofitamab on Day 1 of each 21-day cycle for a maximum of 6 cycles. Glofitamab will be administered using step-up dosing for Cycle 2 on Days 8 and 15, followed by single doses on Day 8 for Cycles 3-6. The starting dose of glofitamab for each arm may be one or more levels below the MTD/OBD determined in Part I.
Group II: Part 2: DLBCL G/R-CHOPExperimental Treatment8 Interventions
Participants with untreated DLBCL will receive G-CHOP or R-CHOP in Cycle 1, followed by G/R-CHOP + glofitamab for subsequent cycles. Glofitamab will be administered using step-up dosing for Cycle 2 on Days 8 and 15, followed by single doses on Day 8 for Cycles 3-6 (up to 8). The starting dose of glofitamab for each arm may be one or more levels below the MTD/OBD determined in Part I.
Group III: Part 1: Dose Escalation r/r NHLExperimental Treatment8 Interventions
Dose finding in participants with r/r NHL: the study will explore different doses of glofitamab in the induction period, starting at a dose of 70 mcg administered in combination with standard of care doses of G/R CHOP and R-CHOP every 3 weeks (Q3W). Participants with r/r NHL will receive 6 cycles of induction treatment (G/R-CHOP). Glofitamab will be administered using step-up dosing for Cycle 2 on Days 8 and 15, followed by single doses on Day 8 for Cycles 3-6. Participants who achieve a complete response (CR), partial response (PR), or stable disease (SD) at the end of induction (EOInd) may optionally receive post-induction treatment (referred to as maintenance) with glofitamab alone. The use of G versus R in Cycle 1 will be compared in parallel dose escalation cohorts.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glofitamab
2021
Completed Phase 1
~60
Rituximab (R)
2005
Completed Phase 2
~60
Tocilizumab
2012
Completed Phase 4
~1840
Cyclophosphamide
1995
Completed Phase 3
~3770
Doxorubicin
2012
Completed Phase 3
~7940
Vincristine
2003
Completed Phase 4
~2910
Prednisone
2014
Completed Phase 4
~2370

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,089,714 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,431 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03467373 — Phase 1
B-Cell Lymphoma Research Study Groups: Part 2: DLBCL Pola-R-CHP, Part 1: Dose Escalation r/r NHL, Part 2: DLBCL G/R-CHOP
B-Cell Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT03467373 — Phase 1
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03467373 — 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 upper limit of participants in this trial?

"Affirmative. According to records stored on clinicaltrials.gov, this medical trial commenced on March 13th 2018 and is currently recruiting participants. It requires 172 patients from one location for completion of the study."

Answered by AI

Are there any open enrollment opportunities for this trial?

"Affirmative, clinicaltrials.gov data alludes to this research study actively recruiting participants. This medicinal investigation was initially posted on March 13th 2018 and was updated most recently on November 4th 2022. 172 patients are being enrolled at a single site."

Answered by AI

What potential risks can patients incur when taking Glofitamab?

"Glofitamab was given a score of 1 due to the fact that this is only Phase 1, meaning there is minimal evidence demonstrating its safety and efficacy."

Answered by AI

What disorders does Glofitamab have the greatest efficacy for?

"Glofitamab is a useful therapy for numerous lung cancers, such as small cell carcinomas (SCLC). It can also be employed to treat thyroiditis and polyangium."

Answered by AI

Have any other reports or investigations been conducted on Glofitamab?

"At present, 1558 trials are underway to assess the efficacy of Glofitamab. Of those studies, 330 have entered Phase 3 and 57052 locations worldwide are participating in these investigations. Most of this research is based out of Bethesda, Maryland."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL
2018. "A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03467373.
~11 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top