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Alkylating agents

Combination Therapy for Lymphoma

Q: What are some of the common afflictions that Rituximab has been shown to improve?

<p>Rituximab can be used to manage <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, synovitis, ophthalmia, and sympathetic patients.</p>

Phase 2

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 specified lymphoma types according to the World Health Organization

Patients must be CD20+

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing new combinations of treatments against the current standard of care to see if they are more effective.

Who is the study for?

This trial is for people over 16 and under 65 with aggressive B-cell lymphoma that's come back or hasn't responded to treatment. They should have had only one prior therapy (up to three if the cancer transformed from a low-grade type). Participants need measurable disease, good organ function, and an ECOG status of 0-2, indicating they can handle intensive chemotherapy. Women must use birth control or be post-menopausal.Check my eligibility

What is being tested?

The study tests new combinations of drugs against standard treatments for relapsed/refractory aggressive B-cell lymphoma. Drugs include Cyclophosphamide, Rituximab, Etoposide, Cisplatin, Dexamethasone, Selinexor, Gemcitabine, Mesna, Ibrutinib & G-CSF. The goal is to see how these combinations affect the disease.See study design

What are the potential side effects?

Possible side effects may include nausea and vomiting from chemotherapy drugs like Cyclophosphamide; allergic reactions to Rituximab; low blood counts leading to infection risk; fatigue; liver issues due to elevated enzymes; kidney problems reflected in creatinine levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphoma type is recognized by the World Health Organization.

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My cancer cells test positive for CD20.

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I am 16 years old or older.

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I can take care of myself and perform daily activities.

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I am healthy enough for intense chemotherapy and stem cell transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Measure overall response rate

Secondary outcome measures

Event free Survival Rate

Number and severity of adverse events

Overall Survival

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Selinexor + R-GDPExperimental Treatment5 Interventions

Selinexor - 40mg PO, D1, D3, D8 Rituximab - 375 mg/m2 IV, 1.5 - 6 hours D1 (prior to cisplatin); Gemcitabine - 1000 mg/m2, IV 30 min D1, D8; Dexamethasone - 40 mg daily PO D1 - D4; Cisplatin - 75 mg/m2 IV, 1 hour D1;

Group II: R-DICEPExperimental Treatment6 Interventions

Rituximab 375 mg/m2 IV 1.5-6hrs Day 1 and Day 5 prior to Cisplatin Mesna 1.75 g/m2 IV 24 hour Cycle 1, Day 2, Day 3 and Day 4 Cyclophosphamide, 1.75 g/m2 IV 2 hours, Day 2, Day 3 and Day 4 Etoposide 350 mg/m2 IV 2 hours, Day 2, Day 3 and Day 4 Cisplatin 35 mg/m2 IV, 2 hours, Day 2, Day 3 and Day 4 G-CSF 300 mcg (<60kg); 480 mcg (60-90kg); 600 mcg (>90kg); SC, Daily, starting Day 15 until apheresis completed.

Group III: Ibrutinib plus R-GDP (ACCRUAL COMPLETE)Experimental Treatment5 Interventions

Ibrutinib 560 mg PO -- D1 - D21 Rituximab 375 mg/m2 IV 1.5 - 6 hours D1 (prior to cisplatin) Gemcitabine 1000 mg/m2 IV 30 min D1, D8 Dexamethasone 40 mg daily PO -- D1 - D4 Cisplatin 75 mg/m2 IV 1 hour D1

Group IV: R-GDPActive Control4 Interventions

Rituximab - 375 mg/m2 IV, 1.5 - 6 hours D1 (prior to cisplatin); Gemcitabine - 1000 mg/m2, IV 30 min D1, D8; Dexamethasone - 40 mg daily PO D1 - D4; Cisplatin - 75 mg/m2 IV, 1 hour D1;

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~1880

Cyclophosphamide

1995

Completed Phase 3

~3770

Etoposide

2010

Completed Phase 3

~2440

Cisplatin

2013

Completed Phase 3

~1940

Dexamethasone

2007

Completed Phase 4

~2590

Selinexor

2020

Completed Phase 2

~1360

Gemcitabine

2017

Completed Phase 3

~2070

Mesna

2003

Completed Phase 2

~1380

Ibrutinib

2014

Completed Phase 3

~1880

G-CSF

2014

Completed Phase 4

~1610

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupLead Sponsor

124 Previous Clinical Trials

67,167 Total Patients Enrolled

8 Trials studying Lymphoma

1,512 Patients Enrolled for Lymphoma

Janssen, LPIndustry Sponsor

160 Previous Clinical Trials

307,670 Total Patients Enrolled

10 Trials studying Lymphoma

705 Patients Enrolled for Lymphoma

Roche Pharma AGIndustry Sponsor

408 Previous Clinical Trials

400,476 Total Patients Enrolled

30 Trials studying Lymphoma

5,536 Patients Enrolled for Lymphoma

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02436707 — Phase 2

Lymphoma Research Study Groups: Ibrutinib plus R-GDP (ACCRUAL COMPLETE), R-GDP, Selinexor + R-GDP, R-DICEP

Lymphoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT02436707 — Phase 2

Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02436707 — Phase 2

Frequently Asked Questions

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

Are there any participant caps for this research project?

"In order to run this study, 320 patients who fit the bill in terms of specific inclusion criteria are required. Luckily, there are many locations where patients can participate, such as BCCA - Vancouver Cancer Centre and Kingston Health Sciences Centre."

Answered by AI

Could I possibly join this clinical trial?

"This clinical trial is looking for 320 participants that currently have lymphoma. The ages of the patients must be between 16 and 65 in order to qualify. There are some additional requirements that potential participants must meet which are as follows: Unclassifiable B-cell lymphoma with indeterminate features between diffuse large B-cell lymphoma and Burkitt lymphoma., Biopsy proof of disease at initial diagnosis is mandatory. A repeat biopsy in primary refractory disease is preferred but not mandatory to confirm progressive disease. A biopsy at relapse is preferred but not mandatory. Participating centres must designate a local reference expert pathologist"

Answered by AI

Does Rituximab come with a lot of risks?

"While there is some data supporting Rituximab's safety, it did not receive a higher score because Phase 2 trials have yet to demonstrate efficacy."

Answered by AI

Are people aged 45 and up being sought for this experiment?

"The age bracket that is eligible for this study begins at 16 and ends when the patient reaches 65 years old."

Answered by AI

Are there historical precedents for using Rituximab?

"Rituximab was first trialled in 1993 at the National Institutes of Health Clinical Center. As of now, 4643 trials have been completed with 2814 currently recruiting patients. A large number of these active trials are based in Vancouver, British Columbia."

Answered by AI

Are new patients being accepted into this study currently?

"That is correct, the information available on clinicaltrials.gov does show that this study is still looking for patients to enroll. This trial was initially posted on May 5th, 2015 and was last updated just a few days ago on May 9th, 2022. The research team wants to have 320 people enrolled across 13 different sites."

Answered by AI