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Alkylating agents

Novel Combination Therapy for B-Cell Lymphoma

Phase < 1
Recruiting
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with histologic diagnosis for one of the following histologies according to the World Health Organization: documented at initial diagnosis or at relapse: Diffuse large cell lymphoma, B-cell (includes primary mediastinal B-cell lymphoma, T-cell rich B-cell lymphoma); Previous indolent lymphoma (follicular lymphoma, marginal zone lymphoma, including extranodal MALT lymphoma, lymphoplasmacytoid lymphoma) with transformation to diffuse large B-cell lymphoma at most recent relapse (biopsy proof of transformation is mandatory).
ECOG performance status 0, 1, 2 or 3.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial is testing a new drug to see what the highest dose is that can be tolerated without causing severe side effects. The new drug is being tested in combination with standard drugs.

Who is the study for?
This trial is for adults under 65 with aggressive B-cell lymphoma that's come back or didn't respond to first treatments. They must be fit enough for intensive chemo and a stem cell transplant, have measurable disease, and not have severe heart issues, uncontrolled infections, or other cancers being treated. Women who can get pregnant and men must agree to contraception.Check my eligibility
What is being tested?
The study tests new drug combinations alongside standard R-GDP chemotherapy (Rituximab, Gemcitabine, Dexamethasone, Cisplatin) or similar regimens in patients whose lymphoma has returned or resisted treatment. It aims to find the highest safe dose of these new combos without causing very severe side effects.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site from Rituximab; low blood counts leading to infection risk; fatigue; nausea from chemotherapy drugs like Cisplatin and Gemcitabine; bleeding risks from Venetoclax; and steroid-related issues such as increased appetite or mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a specific type of lymphoma or my previous lymphoma has transformed into a more aggressive form.
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I can care for myself but may not be able to do heavy physical work.
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My aggressive B-cell lymphoma didn't respond or got worse after one treatment.
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I am 16 years old or older.
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I am under 65 and considered fit for intensive chemotherapy and a stem cell transplant.
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My kidney function, measured by creatinine or GFR, is within the required range.
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I am using or will use effective birth control during and after treatment.
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My cancer can be measured by scans taken within the last 28 days.
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I have had up to 3 treatments for my transformed low-grade lymphoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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
Establish maximum tolerated dose of new combination therapy
Establish recommended Phase II dose of new combination therapy
Secondary outcome measures
Event-free survival
Overall Survival
Overall response rate using RECIL response criteria
+4 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

Trial Design

3Treatment groups
Experimental Treatment
Group I: Venetoclax + R-GDPExperimental Treatment6 Interventions
Group II: Tafasitamab + R-GDPExperimental Treatment1 Intervention
Group III: Glofitamab + R-GDPExperimental Treatment6 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glofitamab
2021
Completed Phase 1
~60
Tafasitamab
2016
Completed Phase 2
~180
Cisplatin
2013
Completed Phase 3
~1940
Gemcitabine
2017
Completed Phase 3
~2070
Venetoclax
2019
Completed Phase 3
~1990
Rituximab SC
2015
Completed Phase 3
~690
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,147 Total Patients Enrolled
Roche Pharma AGIndustry Sponsor
408 Previous Clinical Trials
395,778 Total Patients Enrolled
AbbVieIndustry Sponsor
954 Previous Clinical Trials
501,087 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04161248 — Phase < 1
B-Cell Lymphoma Research Study Groups: Tafasitamab + R-GDP, Glofitamab + R-GDP, Venetoclax + R-GDP
B-Cell Lymphoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT04161248 — Phase < 1
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04161248 — Phase < 1

Frequently Asked Questions

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

Does the research team require additional volunteers for this experiment?

"Affirmative. This clinical trial, which was initially uploaded on December 6th 2019 is still actively recruiting participants and saw its most recent update occur on January 24th 2022. 18 individuals are being sought across 3 different locations."

Answered by AI

What maladies is RiTUXimab Injection commonly used to address?

"Patients with ophthalmia, sympathetic and branch retinal vein occlusion, or advanced testicular cancer may find relief by undergoing RiTUXimab Injection."

Answered by AI

Are there any additional experiments involving RiTUXimab Injection that have been published?

"The National Institutes of Health Clinical Center, 9000 Rockville Pike was the first to research RiTUXimab Injection in 1993. Since then there have been 3462 clinical trials completed and with 2039 still underway; many of these being carried out from Vancouver, British Columbia."

Answered by AI

What is the uppermost limit for participants in this trial?

"This medical trial requires 18 enrollees that meet the established admission criteria. Potential participants can join this study in various locations such as BCCA - Vancouver Cancer Centre and The Jewish General Hospital, both located in Canada."

Answered by AI

Am I eligible to join this research project?

"Eligibility requirements for this trial dictate that applicants must suffer from b-cell lymphoma and be between the ages of 16 and 65. This medical study is currently accepting 18 participants in total."

Answered by AI

Are any individuals below the age of 70 able to participate in this research?

"This trial has established the age range from 16 to 65, with all patients falling within this bracket eligible for enrollment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma
2020. "Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04161248.
~6 spots leftby Dec 2025
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