Combination Therapy for Lymphoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen ByAlex F Herrera

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial studies a combination of drugs to treat patients with diffuse large B-cell lymphoma that has come back or did not respond to previous treatments. The treatment includes a targeted drug that delivers a toxin to cancer cells, an antibody that stops cancer growth, and chemotherapy drugs that kill or stop the division of cancer cells. The goal is to see if this combination is safe and effective.

Eligibility Criteria

This trial is for adults with relapsed or refractory diffuse large B-cell lymphoma who have had one prior treatment including CD20-directed immunotherapy and chemotherapy. They must be in good enough health to undergo high-dose chemotherapy followed by a stem cell transplant, not have severe allergies to similar drugs, no active infections or other cancers, and agree to use birth control.

Inclusion Criteria

I can perform all my self-care but may not be able to do heavy physical work.

I have recovered from side effects of cancer treatment, except for hair loss.

I have been diagnosed with a specific type of lymphoma called diffuse large B-cell.

My blood clotting tests are within normal limits, or if I'm on blood thinners, they're properly adjusted.

I have a tumor that is larger than 1.5 cm, confirmed by a CT or PET/CT scan.

Exclusion Criteria

I have never had, nor do I currently have, a brain infection known as PML.

I am not pregnant or breastfeeding.

I am currently on medication for an infection.

I haven't had major surgery in the last 4 weeks, except for diagnostic purposes.

I have had a solid organ transplant.

I have not had heart problems, stroke, or a heart attack in the last 6 months.

My lymphoma has spread to my brain or spinal cord.

I am not a candidate for a stem cell transplant.

Participant Groups

The PolaR-ICE trial tests a combination of polatuzumab vedotin (an antibody-drug conjugate), rituximab (an antibody), and chemotherapy agents ifosfamide, carboplatin, and etoposide as initial salvage therapy. It aims to see if this mix can better kill cancer cells in patients whose disease returned or resisted previous treatment.

1Treatment groups

Experimental Treatment

Group I: Treatment (PolaR-ICE)Experimental Treatment5 Interventions

SALVAGE THERAPY: Patients receive polatuzumab vedotin IV on day 1, rituximab IV on day 1, etoposide IV on days 1-3, carboplatin IV on day 2, and ifosfamide IV on day 2 or days 1-3. Treatment repeats every 21 days for up to 2-3 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response or stable disease by C2D15 may receive 1 additional cycle of PolaR-ICE IV. CONSOLIDATION THERAPY: Within 30-60 days after ASCT, patients receive polatuzumab vedotin IV on day 1. Treatment repeats every 21 days for up to 3-4 cycles 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: