Study on Brentuximab Vedotin and Chemotherapy for Treating CD30-Positive Peripheral T-cell Lymphoma

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT03113500

Provider View

This clinical trial is testing a combination of brentuximab vedotin and chemotherapy to see how well it works and what side effects it might have in patients with CD30-positive peripheral T-cell lymphoma.

Patient Parameters

Program Overview

The study aims to find out if a combination of brentuximab vedotin, a targeted therapy, and chemotherapy drugs can effectively treat CD30-positive peripheral T-cell lymphoma. Brentuximab vedotin targets and kills cancer cells with the CD30 marker. The chemotherapy drugs work by stopping cancer cells from growing and spreading. This trial will help determine if this combination is more effective than current treatments.

Description

The main goals of this study are to evaluate the safety and effectiveness of a treatment regimen called CHEP-BV, which includes the drugs cyclophosphamide, doxorubicin, etoposide, prednisone, and brentuximab vedotin, for patients with CD30-positive peripheral T-cell lymphoma (PTCL). The study will also look at how well patients respond to this treatment and whether they can benefit from additional brentuximab vedotin therapy after the initial treatment.

Treatment Plan:

  • Induction Phase: Patients will receive a combination of chemotherapy drugs (cyclophosphamide, doxorubicin, etoposide, and prednisone) along with brentuximab vedotin. This treatment is given in cycles, with each cycle lasting 21 days, for up to 6 cycles.

  • Consolidation Phase: After the initial treatment, patients who respond well may receive additional brentuximab vedotin therapy every 21 days for up to 10 cycles.

Patients will be monitored for side effects and treatment effectiveness throughout the study. Follow-up visits will occur at 30 days, 6 months, and 12 months after completing the study treatment.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Must agree to allow the use of previous tumor biopsy samples.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must have a confirmed diagnosis of specific types of peripheral T-cell lymphoma, such as ALK-positive or ALK-negative anaplastic large cell lymphoma, PTCL-not otherwise specified, and others.
  • Cancer cells must be CD30-positive.
  • Must have measurable disease on scans.
  • Must meet specific blood count and organ function criteria.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 6 months after.
  • Men must agree to use effective birth control during the study and for 6 months after.

Exclusion Criteria

  • Previous treatment for PTCL with certain therapies, except for one cycle of specific chemotherapy regimens.
  • History of another cancer that has not been in remission for at least 3 years, except for certain skin and cervical cancers.
  • Heart disease, stroke, or heart attack within the past 6 months.
  • Lymphoma involving the central nervous system.
  • Active severe infections or known infections like HIV or hepatitis.
  • Severe nerve damage or certain genetic nerve disorders.
  • Known allergies to study drugs.
  • Pregnant or breastfeeding women.
  • Any condition that would prevent participation in the study, as determined by the investigator.

Locations

FACILITYZIPCITYSTATE
City of Hope Comprehensive Cancer Center91010DuarteCalifornia
Hackensack University Medical Center07601HackensackNew Jersey
Ohio State University Comprehensive Cancer Center43210ColumbusOhio
M D Anderson Cancer Center77030HoustonTexas

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