Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Seagen Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

13 Jul 2021 → 24 Aug 2024

Decision date (initial)

2023-10-23

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

External identifiers

EU CT number

2023-503387-16-00

EudraCT number

2020-004027-17

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Parts C: To assess the complete response (CR) rate at EOT with AN+AD in subjects with previously untreated cHL

Conditions and MedDRA coding

Classical Hodgkin Lymphoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Treatment-naïve, cHL subjects: Subjects enrolling in Part C of the study must have Ann Arbor Stage I or II cHL without bulky mediastinal disease
2. Histologically confirmed cHL according to the current World Health Organization Classification
3. Bidimensional measurable disease as documented by PET/CT or CT imaging
4. Age 12 years or older in the United States. For regions outside of the United States, subjects must be age 18 years or older
5. An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion criteria 17

1. Nodular lymphocyte predominant HL
2. 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 nonmelanoma skin cancer, localized prostate cancer, or carcinoma in situ of any type are not excluded if they have undergone complete resection
3. Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 4 weeks of first study drug dose.
4. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting Tcell co-stimulation or checkpoint pathways
5. Active cerebral/meningeal disease related to the underlying malignancy.
6. Any active 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
7. Current therapy with other systemic anti-neoplastic or investigational agents
8. Planned consolidative radiotherapy during the study treatment period (Parts B and C only)
9. Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity (Parts B and C only)
10. Grade 3 or higher pulmonary disease unrelated to underlying malignancy
11. Idiopathic interstitial pneumonia or diffusing capacity of the lung for carbon monoxide <50% predicted
12. Documented history of a cerebral vascular event within 6 months prior to their first dose of brentuximab vedotin
13. Subjects with Child-Pugh B or C hepatic impairment
14. Grade 2 or higher peripheral sensory or motor neuropathy at baseline
15. Subjects with acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against GvHD
16. Previous treatment with brentuximab vedotin
17. Subjects who are pregnant or breastfeeding

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. CR rate at EOT

Secondary endpoints 6

1. Incidence, severity, seriousness, and relatedness of AEs; incidence and severity of lab abnormalities
2. Estimate the ORR
3. DOR
4. DOCR
5. EFS
6. PFS

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Seagen Inc.

Sponsor organisation

Seagen Inc.

Address

21823 30th Drive Southeast

City

Bothell

Postcode

98021-3907

Country

United States

Scientific contact point

Organisation

Seagen Inc.

Contact name

Francisco Beca

Public contact point

Organisation

Seagen Inc.

Contact name

Seagen Clinical Trial Information

Third parties 7

Locations

4 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications