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-cell 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.
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
Drug | Synonyms | Arms |
---|
brentuximab vedotin | ADCETRIS | CD30-negative Cohort |
cyclophosphamide | | CD30-negative Cohort |
doxorubicin | | CD30-negative Cohort |
prednisone | | CD30-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-cell 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
Name | Type | Description | Interventions |
---|
CD30-negative Cohort | Experimental | Participants with CD30 expression level < 1% | - brentuximab vedotin
- cyclophosphamide
- doxorubicin
- prednisone
|
CD30-positive Cohort | Experimental | Participants 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 in tumor containing lymph node or other
extranodal soft tissue biopsy
- 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 or doxorubicin.
- 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: | An adverse event is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment |
Measure: | Incidence of laboratory abnormalities |
Time Frame: | From start of study treatment up to approximately 7 months |
Safety Issue: | |
Description: | To be summarized using descriptive statistics. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Seagen Inc. |
Trial Keywords
- CD30-positive
- CD30-negative
- Seattle Genetics
Last Updated
August 24, 2021