A study of brentuximab vedotin with Hodgkin lymphoma (HL) and CD30-expressing peripheral T-cell lymphoma (PTCL)
- Conditions
- • Hodgkin lymphoma (HL)• CD30-expressing peripheral T-cell lymphoma (PTCL)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: 20.0Level: PTClassification code 10073478Term: Anaplastic large-cell lymphomaSystem 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
- EUCTR2019-003982-17-IT
- Lead Sponsor
- SEATTLE GENETICS, INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
Study parts E and F:
1. Treatment-naive patients with histopathological diagnosis of classical HL (Part E), or treatment-naive patients with CD30-expressing (> or = 1%) PTCL (Part F).
2. age > or = 18 years
3. Patients must be unsuitable or unfit for initial conventional combination chemotherapy for HL or CD30-expressing PTCL due to the presence of comorbidity-related factors, as documented by:
a. a CIRS score > or = 10 OR
b. requiring assistance with or dependence on others for any IADLs.
4. Patients must have fluorodeoxyglucose (FDG)-PET-avid and bidimensional measurable disease of at least 1.5 cm in longest axis as documented by radiographic technique.
5. An Eastern Cooperative Oncology Group (ECOG) Performance Status score of < or = 3
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
1. Baseline peripheral neuropathy Grade > or = 2 or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
2. History of progressive multifocal leukoencephalopathy (PML)
3. Any active Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin. Routine antimicrobial prophylaxis is permitted.
7. Kidney disease requiring ongoing dialysis
15. Known cerebral/meningeal disease related to the underlying malignancy.
17. Known to be positive for hepatitis B by surface antigen expression. Known to be positive for hepatitis C infection (positive by polymerase chain reaction [PCR]). Patients who have been treated for hepatitis C infection are permitted if they have documented sustained virologic response of 12 weeks
18. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
19. Active hepatitis C infection (positive by serology and confirmed by PCR or on antiviral therapy for hepatitis C within the last 6 months).
21. History of another malignancy within 1 year 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to assess the response rates (ORR) of single-agent brentuximab vedotin as frontline therapy in patients age > or = 60 years and in patients ineligible for conventional combination chemotherapy due to comorbidities.;Secondary Objective: - To evaluate safety and tolerability of single-agent brentuximab vedotin<br>- To assess duration of response<br>- To assess complete remission (CR) rate<br>- To assess progression-free survival (PFS)<br>- To assess resolution of B symptoms<br>- To assess pharmacokinetics and immunogenicity of brentuximab vedotin<br>- To assess overall survival (OS);Primary end point(s): ORR according to modified Lugano criteria. The assessment will be per blinded independent central review (BICR);Timepoint(s) of evaluation of this end point: Through 1 month following last dose; up to approximately 18 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Type, incidence, severity, seriousness, and relatedness of AEs and laboratory abnormalities<br>- CR rate, disease control rate, duration of ORR, duration of CR, and PFS<br>- ORR according to Lugano criteria per BICR<br>- B symptom resolution rate<br>- Estimates of selected PK parameters<br>- Incidence of antitherapeutic antibodies (ATA) to brentuximab vedotin <br>- OS;Timepoint(s) of evaluation of this end point: • Through 1 month following last dose; up to approximately 18 months<br>• Up to approximately 5 years<br>• Through 1 month following last dose; up to approximately 18 months<br>• Through 1 month following last dose; up to approximately 18 months<br>• At each treatment cycle<br>• Through 1 month following last dose; up to approximately 18 months<br>• Up to approximately 5 years