Chemotherapy + Carfilzomib for Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen byFrancisco J. Hernandez-ILizaliturri

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Roswell Park Cancer Institute

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase I/Ib trial studies the side effects and best dose of carfilzomib when given together with rituximab, ifosfamide, carboplatin, and etoposide and to see how well it works in treating patients with stage I-IV diffuse large B-cell lymphoma that has returned (relapsed) or that has not responded to treatment (refractory). Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, also work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib with rituximab, ifosfamide, carboplatin, and etoposide may be a better treatment for diffuse large B-cell lymphoma.

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

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Exclusion Criteria

I have active brain or spinal cord lymphoma but am still eligible if a specific test shows DLBCL at registration.

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

I have symptoms from cancer spreading to my brain.

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Treatment Details

Interventions

Carboplatin (Platinum-containing Compound)
Carfilzomib (Proteasome Inhibitor)
Etoposide (Topoisomerase Inhibitor)
Ifosfamide (Alkylating agents)
Rituximab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: