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Platinum-containing Compound

Chemotherapy + Carfilzomib for Lymphoma

Phase 1

Waitlist Available

Led By Francisco Hernandez-ILizaliturri

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ann Arbor stage I to stage IV DLBCL at the time of relapsed/refractory disease to be eligible

Measurable or assessable disease is required; measurable tumor size (at least one node measuring 2.25 cm^2 in bidimensional measurement) per computed tomography (CT) scan, other radiological study, and/or physical exam

Must not have

Positive serology for HBV defined as a positive test for HBsAg; in addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HepB DNA test will be performed and if positive the subject will be excluded

Patients with symptomatic brain involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying carfilzomib given with rituximab, ifosfamide, carboplatin, and etoposide to see how well it works and what the side effects are.

Who is the study for?

This trial is for adults with stage I-IV diffuse large B-cell lymphoma that has relapsed or is refractory. Participants must have had at least one prior rituximab-based treatment, measurable disease, and adequate organ function. They should not be pregnant/breastfeeding, HIV positive, have certain other cancers or severe medical conditions.

What is being tested?

The study tests the safety and optimal dose of carfilzomib combined with rituximab, ifosfamide, carboplatin, and etoposide in treating relapsed/refractory diffuse large B-cell lymphoma to see how well it works compared to standard treatments.

What are the potential side effects?

Potential side effects include reactions related to immune response (rituximab), blood cell count changes (ifosfamide), kidney function issues (carboplatin), gastrointestinal symptoms (etoposide) and possible heart complications due to carfilzomib.

Eligibility Criteria

Inclusion Criteria

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

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My DLBCL is between stage I and IV and has come back or not responded to treatment.

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I have a tumor that can be measured and is at least 2.25 cm^2 in size.

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My lymphoma has returned or didn't respond to treatment and tests positive for CD20.

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My kidney function is normal or meets the trial's requirements.

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My heart's pumping ability is normal, confirmed by a heart scan.

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I do not have active hepatitis B but am immune to it.

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I have had at least one treatment that included rituximab for my condition.

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I am able to live at home and care for most of my personal needs.

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My liver tests are within the required range.

Exclusion Criteria

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

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I have tested positive for hepatitis B surface antigen or have hepatitis B core antibodies with a negative DNA test.

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I have symptoms from cancer spreading to my brain.

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My condition is non-Hodgkin lymphoma, not including DLBCL.

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I have undergone high-dose chemotherapy with stem cell transplant.

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I have not had major surgery in the last 2 weeks.

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I do not have any serious illnesses that could affect my participation in the study.

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I am allergic to Captisol.

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I am on long-term high dose steroids (more than 10 mg/day of prednisone or equivalent).

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I have moderate to severe nerve pain or damage.

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I haven't had a heart attack in the last 6 months and don't have severe heart issues.

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I haven't had chemotherapy in the last 3 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Overall Response Rate (PR + CR)

Secondary study objectives

Complete Response Rate According to the International Working Group Response Criteria as Reported by the Revised Cheson Criteria

Overall Survival

Pharmacokinetics (PK)/Pharmacodynamics (PD) of Carfilzomib and Standard R-ICE Combination Therapy in Adult Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (carfilzomib, rituximab, chemotherapy)Experimental Treatment7 Interventions

Patients receive carfilzomib IV over 10-30 minutes on days 1, 2, 8, and 9; rituximab IV over 3-8 hours on day 3; etoposide IV over 1 hour on days 4-6; carboplatin IV over 1 hour on day 5; and ifosfamide IV over 24 hours on day 5. Treatment repeats every 21-28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

Ifosfamide

2010

Completed Phase 4

~3140