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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    80
  • sponsor
    Seagen Inc.
Updated on 16 January 2022
cancer
cyclophosphamide
prednisone
measurable disease
leukemia
adult t-cell leukemia/lymphoma
doxorubicin
avid
peripheral t-cell lymphoma
angioimmunoblastic t-cell lymphoma
anaplastic large cell lymphoma
large cell lymphoma
brentuximab
t-cell leukemia

Summary

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.

Details
Condition Peripheral T-cell Lymphoma
Treatment cyclophosphamide, prednisone, doxorubicin, brentuximab vedotin
Clinical Study IdentifierNCT04569032
SponsorSeagen Inc.
Last Modified on16 January 2022

Eligibility

Yes No Not Sure

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
Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT, as assessed by the site radiologist
extranodal soft tissue biopsy
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 progressive multifocal leukoencephalopathy (PML)
History of another primary invasive cancer, hematologic malignancy, or myelodysplastic
Cerebral/meningeal disease related to the underlying malignancy
syndrome that has not been in remission for at least 3 years. Exceptions are
Prior treatment with brentuximab vedotin or doxorubicin
malignancies with a negligible risk of metastasis or death (e.g., 5-year OS
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
≥90%), such as carcinoma in situ of the cervix, non-melanoma skin carcinoma
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
localized prostate cancer, ductal carcinoma in situ, or Stage I uterine
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
cancer
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