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Alkylating agents

Combination Therapy for Lymphoma

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+

Must not have

History of other malignancies except specified

History of HIV, active Hepatitis C Virus infection, active Hepatitis B Virus infection, or uncontrolled active systemic infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer before, but it fits the exceptions listed.

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I do not have HIV, active Hepatitis B or C, or any uncontrolled infections.

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I have not received any live vaccines in the last 4 weeks.

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I have a serious illness or medical condition besides cancer.

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I have not had major surgery in the last 10 days.

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I have a serious heart condition.

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My brain or spinal cord cancer is not under control.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure overall response rate

Secondary study objectives

Event free Survival Rate

Number and severity of adverse events

Stem cell collection rate

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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-DICEP (ACCRUAL COMPLETE)Experimental 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

~2990

Cyclophosphamide

2010

Completed Phase 4

~2310