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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04569032
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : June 28, 2022
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral T-cell Lymphoma Drug: brentuximab vedotin Drug: cyclophosphamide Drug: doxorubicin Drug: prednisone Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 12, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: CD30-negative Cohort
Participants with CD30 expression level < 1%
Drug: brentuximab vedotin
1.8 mg/kg administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle
Other Name: ADCETRIS

Drug: cyclophosphamide
750 mg/m^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

Drug: doxorubicin
50 mg/m^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

Drug: prednisone
100 mg daily administered orally on Days 1-5 of each cycle

Experimental: CD30-positive Cohort
Participants with CD30 expression level ≥1% to < 10%
Drug: brentuximab vedotin
1.8 mg/kg administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle
Other Name: ADCETRIS

Drug: cyclophosphamide
750 mg/m^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

Drug: doxorubicin
50 mg/m^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

Drug: prednisone
100 mg daily administered orally on Days 1-5 of each cycle




Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Complete response (CR) rate per BICR [ Time Frame: From start of study treatment up to approximately 7 months ]
    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).

  2. Progression-free survival (PFS) per BICR [ Time Frame: Up to approximately 3 years ]
    Time from start of treatment to the first documented disease progression or death from any cause, whichever comes first

  3. Overall survival [ Time Frame: Up to approximately 3 years ]
    Time from first dose to death due to any cause

  4. Duration of response (DOR) per BICR [ Time Frame: Approximately 3 years ]
    Time from first occurrence of an objective response to the date of disease progression or death from any cause, whichever comes first

  5. ORR per BICR per modified Lugano criteria (Cheson 2014) [ Time Frame: From start of study treatment up to approximately 7 months ]
    ORR is defined as the proportion of participants with CR or PR at the completion of study treatment

  6. Incidence of adverse events [ Time Frame: From start of study treatment up to approximately 7 months ]
    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

  7. Incidence of laboratory abnormalities [ Time Frame: From start of study treatment up to approximately 7 months ]
    To be summarized using descriptive statistics.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04569032


Contacts
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Contact: Seagen Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
Show Show 41 study locations
Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Scott Knowles, MD, PhD Seagen Inc.
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT04569032    
Other Study ID Numbers: SGN35-032
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: June 28, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen Inc.:
CD30-positive
CD30-negative
Seattle Genetics
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Prednisone
Cyclophosphamide
Doxorubicin
Brentuximab Vedotin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones