Brentuximab Vedotin + R-CHP for Non-Hodgkin's Lymphoma
(BV mini CHP Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byPatrick M Reagan, MD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Patrick Reagan

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a study incorporating brentuximab vedotin and dose attenuated rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) into initial therapy for elderly patients with DLBCL. Vincristine will be omitted from the standard R-CHOP regimen given the overlapping toxicities with brentuximab vedotin.

Eligibility Criteria

This trial is for men and women aged 75 or older with a specific type of blood cancer called DLBCL. They must be able to consent, have an ECOG performance status of 0-3, no prior therapy for their condition (except possibly prednisone), and adequate liver function. People with certain other health conditions or treatments are excluded.

Inclusion Criteria

My lymphoma has both slow-growing and aggressive features.

I understand the study details and am willing to sign the consent form.

I have not had treatment for DLBCL or HT, except possibly a short course of prednisone.

See 7 more

Exclusion Criteria

HIV positive

I am currently on dialysis.

My heart's pumping ability is significantly reduced.

See 12 more

Treatment Details

Interventions

Brentuximab Vedotin (Monoclonal Antibodies)
Cyclophosphamide (Alkylating agents)
Doxorubicin (Anti-tumor antibiotic)
Prednisone (Corticosteroid)
Rituximab (Monoclonal Antibodies)

Trial OverviewThe study tests a combination of drugs: brentuximab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone in elderly patients with DLBCL. It modifies the standard R-CHOP regimen by omitting vincristine due to its overlapping toxicities with brentuximab vedotin.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: BV+mini-R-CHPExperimental Treatment5 Interventions

Brentuximab vedotin 1.8 mg/kg IV day 1 for six cycles Rituximab 375 mg/m2 IV day 1 for six cycles Cyclophosphamide 400 mg/m2 IV day 1for six cycles Doxorubicin 25 mg/m2 IV day 1 for six cycles Prednisone 40 mg/m1 PO days 1-5 for six cycles

Brentuximab Vedotin is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Adcetris for: