A phase 2 study of retreatment with brentuximab vedotin in subjects with classic Hodgkin lymphoma or CD30-expressing peripheral T cell lymphoma

Phase 1

• Conditions: - classic Hodgkin lymphoma (cHL)- Systemic anaplastic large cell lymphoma (sALCL)- CD30-expressing peripheral T cell lymphoma (PTCL); MedDRA version: 20.0Level: PTClassification code 10073478Term: Anaplastic large-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10034623Term: Peripheral T-cell lymphoma unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10034624Term: Peripheral T-cell lymphoma unspecified NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10001412Term: Adult T-cell leukemia-lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10065855Term: Extranodal NK/T-cell lymphoma, nasal typeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10073481Term: Enteropathy-associated T-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10022703Term: Intestinal T-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10061232Term: Lymphoproliferative disorderSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2019-003983-28-IT
• Lead Sponsor: SEAGEN INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-25
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

- Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL.
- Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or
relapse after discontinuing treatment.
- Documentation of disease relapse or progression > o = 6 months after the last dose of brentuximab vedotin.
- Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional measurable disease of at least 1.5 cm in longest axis
as documented by radiographic technique.
- An Eastern Cooperative Oncology Group (ECOG) performance status < o = 2.
- Must not be pregnant and, if of childbearing or fathering potential, must agree to use 2 effective contraception methods during study and
for 6 months following last dose of study drug.
- Age 18 or older.

Other protocol defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

- Subjects who previously discontinued brentuximab vedotin due to any
Grade 3 or higher toxicity.
- Subjects with existing Grade 2 or higher peripheral neuropathy.
- Subjects who were previously refractory to treatment with brentuximab vedotin.
- Documented history of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms within 6 months prior to
their first dose of brentuximab vedotin.
- History of another malignancy within 3 years before the first dose of study drug or any evidence of residual disease from a previously
diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
- Subjects with acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis
agent against GvHD.
- Active cerebral/meningeal disease.
- History of progressive multifocal leukoencephalopathy (PML).
- Any active uncontrolled Grade 3 or higher (per the National Cancer Institute's Common Terminology Criteria for AEs, NCI CTCAE Version
5.0) viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of brentuximab vedotin in this study.
- Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to
first dose of study drug, unless underlying disease has progressed on treatment.
- Subjects < 100 days from allogeneic transplant.
- Post-allogeneic transplant subjects with any detectable level of cytomegalovirus (CMV) by polymerase chain reaction (PCR).
- Prior donor lymphocyte infusion < 8 weeks prior to first dose of study drug.

Other protocol defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified