Clinical Trials /

A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression

NCT04569032

Description:

This clinical trial will study brentuximab vedotin with CHP to find out if the drugs work for people who have certain types of peripheral T-call lymphoma (PTCL). It will also find out what side effects occur when brentuximab vedotin and CHP are used together. A side effect is anything the drugs do besides treating cancer. CHP is a type of chemotherapy that uses three drugs (cyclophosphamide, doxorubicin, and prednisone). CHP is approved by the FDA to treat certain types of PTCL.

Related Conditions:
  • Adult T-Cell Leukemia/Lymphoma
  • Angioimmunoblastic T-Cell Lymphoma
  • Enteropathy-Associated T-Cell Lymphoma
  • Follicular T-Cell Lymphoma
  • Hepatosplenic T-Cell Lymphoma
  • Indolent T-Cell Lymphoproliferative Disorder of the Gastrointestinal Tract
  • Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma
  • Nodal Peripheral T-Cell Lymphoma with TFH Phenotype
  • Peripheral T-Cell Lymphoma, Not Otherwise Specified
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression
  • Official Title: A Dual-cohort, Open-label, Phase 2 Study of Brentuximab Vedotin and CHP (A+CHP) in the Frontline Treatment of Subjects With Peripheral T-cell Lymphoma (PTCL) With Less Than 10% CD30 Expression

Clinical Trial IDs

  • ORG STUDY ID: SGN35-032
  • NCT ID: NCT04569032

Conditions

  • Peripheral T-cell Lymphoma

Interventions

DrugSynonymsArms
brentuximab vedotinADCETRISCD30-negative Cohort
cyclophosphamideCD30-negative Cohort
doxorubicinCD30-negative Cohort
prednisoneCD30-negative Cohort

Purpose

This clinical trial will study brentuximab vedotin with CHP to find out if the drugs work for people who have certain types of peripheral T-call lymphoma (PTCL). It will also find out what side effects occur when brentuximab vedotin and CHP are used together. A side effect is anything the drugs do besides treating cancer. CHP is a type of chemotherapy that uses three drugs (cyclophosphamide, doxorubicin, and prednisone). CHP is approved by the FDA to treat certain types of PTCL.

Trial Arms

NameTypeDescriptionInterventions
CD30-negative CohortExperimentalParticipants with CD30 expression level < 1%
  • brentuximab vedotin
  • cyclophosphamide
  • doxorubicin
  • prednisone
CD30-positive CohortExperimentalParticipants with CD30 expression level ≥1% to < 10%
  • brentuximab vedotin
  • cyclophosphamide
  • doxorubicin
  • prednisone

Eligibility Criteria

        Inclusion Criteria

          -  Newly diagnosed PTCL, excluding systemic anaplastic large cell lymphoma (sALCL), per
             the Revised European-American Lymphoma World Health Organization (WHO) 2016
             classification

          -  The following non-sALCL PTCL subtypes are eligible:

               -  PTCL - not otherwise specified (PTCL-NOS)

               -  Angioimmunoblastic T-cell lymphoma (AITL)

               -  Adult T-cell leukemia/lymphoma (ATLL; acute and lymphoma types only, must be
                  positive for human T cell leukemia virus 1)

               -  Enteropathy-associated T-cell lymphoma (EATL)

               -  Hepatosplenic T-cell lymphoma

               -  Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITCL)

               -  Indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI)
                  tract

               -  Follicular T-cell lymphoma

               -  Nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype

          -  CD30 expression <10% by local assessment

          -  Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm
             by CT, as assessed by the site radiologist

          -  An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
             2

        Exclusion Criteria

          -  Current diagnosis of any of the following:

               -  sALCL

               -  Primary cutaneous T-cell lymphoproliferative disorders and lymphomas

               -  Mycosis fungoides (MF), including transformed MF

          -  History of another primary invasive cancer, hematologic malignancy, or myelodysplastic
             syndrome that has not been in remission for at least 3 years. Exceptions are
             malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%),
             such as carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized
             prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.

          -  History of progressive multifocal leukoencephalopathy (PML).

          -  Cerebral/meningeal disease related to the underlying malignancy.

          -  Prior treatment with brentuximab vedotin.

          -  Baseline peripheral neuropathy Grade 2 or higher (per the NCI CTCAE, Version 4.03) or
             subjects with the demyelinating form of Charcot-Marie-Tooth syndrome.

          -  Left ventricular ejection fraction less than 45% or symptomatic cardiac disease
             (including symptomatic ventricular dysfunction, symptomatic coronary artery disease,
             and symptomatic arrhythmias), or myocardial infarction within the past 6 months, or
             previous treatment with complete cumulative dose of >300 mg/m2 of doxorubicin.

          -  Any uncontrolled Grade 3 or higher (per the National Cancer Institute's Common
             Terminology Criteria for Adverse Events, NCI CTCAE Version 4.03) viral, bacterial, or
             fungal infection within 2 weeks prior to the first dose of study drug. Routine
             antimicrobial prophylaxis is permitted.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR) per blinded independent central review (BICR) using Revised Response Criteria for Malignant Lymphoma criteria (Cheson 2007)
Time Frame:From start of study treatment up to approximately 7 months
Safety Issue:
Description:ORR is defined as the proportion of participants with complete response (CR) or partial response (PR) at the completion of study treatment

Secondary Outcome Measures

Measure:Complete response (CR) rate per BICR
Time Frame:From start of study treatment up to approximately 7 months
Safety Issue:
Description:CR rate is defined as the proportion of participants with CR following the completion of study treatment using Revised Response Criteria of Malignant Lymphoma (Cheson 2007).
Measure:Progression-free survival (PFS) per BICR
Time Frame:Up to approximately 3 years
Safety Issue:
Description:Time from start of treatment to the first documented disease progression or death from any cause, whichever comes first
Measure:Overall survival
Time Frame:Up to approximately 3 years
Safety Issue:
Description:Time from first dose to death due to any cause
Measure:Duration of response (DOR) per BICR
Time Frame:Approximately 3 years
Safety Issue:
Description:Time from first occurrence of an objective response to the date of disease progression or death from any cause, whichever comes first
Measure:ORR per BICR per modified Lugano criteria (Cheson 2014)
Time Frame:From start of study treatment up to approximately 7 months
Safety Issue:
Description:ORR is defined as the proportion of participants with CR or PR at the completion of study treatment
Measure:Incidence of adverse events
Time Frame:From start of study treatment up to approximately 7 months
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities
Time Frame:From start of study treatment up to approximately 7 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Seattle Genetics, Inc.

Trial Keywords

  • CD30-positive
  • CD30-negative

Last Updated

October 6, 2020