Phase 4 Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma Not Suitable for Stem Cell Transplantation or Multiagent Chemotherapy

• Register: EUCTR
• Last refreshed on: 5 April 2021
• Main ID: EUCTR2013-000232-10-PL
• Date of registration: 02/01/2014
• Prospective Registration: Yes
• Primary sponsor: Millennium Pharmaceuticals, Inc
• Public title: Phase 4 Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma Not Suitable for Stem Cell Transplantation or Multiagent Chemotherapy
• Scientific title: A Single-arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma Who Are Not Suitable for Stem Cell Transplantation or Multiagent Chemotherapy
• Date of first enrolment: 09/02/2014
• Target sample size: 60
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000232-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Czech Republic, Germany, Malaysia, Poland, Spain, Thailand, Turkey

Contacts

• Name: Drug Information Call Centre
• Affiliation: Millennium, Drug Information Call Centre

• Name: Drug Information Call Centre
• Affiliation: Millennium, Drug Information Call Centre

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female patients 18 years or older.
2. A diagnosis of relapsed or refractory classical HL, confirmed by biopsy if clinically feasible on the basis of local pathology review.
3. A history of at least 1 prior systemic chemotherapeutic regimen.
4. Not suitable for SCT or multiagent chemotherapy
5. Bidimensional measurable disease, of at least 1.5 cm, as documented by radiographic technique (spiral CT scan preferred), per IWG Revised Response Criteria for Malignant Lymphoma.
6. Patients must have completed any prior immunotherapy (eg, rituximab) or radioisotopic therapy at least 12 weeks before the first dose of brentuximab vedotin in the absence of clear disease progression.
7. Patient has recovered to Grade 1 or lower toxicity related to radiotherapy, immunotherapy, and chemotherapy unless evidence of toxicity is due to underlying HL. If toxicity is related to underlying HL, Grade 2 or lower toxicity is acceptable.

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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
1. Previous treatment with brentuximab vedotin.
2. Previously received an ASCT or alloSCT.
3. Female patients who are lactating and breastfeeding or have a positive serum or urine
pregnancy test during the Screening period or a positive serum or urine pregnancy
test on Day 1 before first dose of study drug.
4. Any serious medical or psychiatric illness that could, in the investigator’s opinion,
potentially interfere with the completion of treatment according to this protocol.
5. Treatment with any investigational products within 4 weeks before the first dose of
study drug.
6. Any of the following cardiovascular conditions or values within 6 months before the
first dose of study drug:
- New York Heart Association Class III or IV heart failure
- Myocardial infarction within 6 months before the first dose of study drug
- Evidence of current uncontrolled cardiovascular conditions, including
clinically relevant cardiac arrhythmias, congestive heart failure (CHF),
angina, or electrocardiographic evidence of acute ischemia or active
conduction system abnormalities
7. History of another primary malignancy that has not been in remission for at least
3 years. (The following are exempt from the 3-year limit: nonmelanoma skin
cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on
biopsy or a squamous intraepithelial lesion on PAP smear.)
8. Any active uncontrolled systemic viral, bacterial, or fungal infection.
9. Any antimicrobial, antiviral, or antifungal therapy within 1 week prior to the first
dose of brentuximab vedotin (routine prophylaxis is acceptable).
10. Known cerebral/meningeal disease, including signs or symptoms suggestive of PML,
or any history of PML.
11. Known human immunodeficiency virus (HIV).
12. Known hepatitis B surface antigen positive, or known or suspected active hepatitis C
infection.
13. Grade 2 or higher peripheral neuropathy.
14. Current therapy with other systemic antineoplastic or investigational agents.
15. Therapy with corticosteroids at higher than or equal to 20 mg/day of prednisone
equivalent within 1 week before administration of the first dose of brentuximab
vedotin.
16. Patients with a known hypersensitivity to recombinant proteins, murine proteins, or
any excipient contained in the drug formulation.
17. Patients with dementia or an altered mental state that would preclude the
understanding and rendering of informed consent.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Relapsed or Refractory Hodgkin Lymphoma
MedDRA version: 20.0 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease System Organ Class: 10005329 - Blood and lymphatic system disorders

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: ADCETRIS
Product Name: ADCETRIS
Product Code: SGN-35
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Brentuximab vedotin
CAS Number: 914088-09-8
Current Sponsor code: SGN-35
Other descriptive name: BRENTUXIMAB VEDOTIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Main Objective: To assess the antitumor efficacy, as determined by the objective response rate (ORR) of
single-agent brentuximab vedotin 1.8 mg/kg administered intravenously (IV) every 3 weeks,
in patients with relapsed or refractory classical HL who are considered to be not suitable for
SCT or multiagent chemotherapy

Secondary Objective: To determine the duration of tumor control, including the duration of response (DOR),
progression-free survival (PFS), and complete remission (CR) rate by independent review
facility (IRF) assessment after treatment with brentuximab vedotin
To determine the proportion of patients who receive hematopoietic SCT, either autologous
stem cell transplantation (ASCT) or allogeneic stem cell transplantation (alloSCT) after
treatment with brentuximab vedotin
To determine overall survival (OS) after treatment with brentuximab vedotin
To assess the safety and tolerability of brentuximab vedotin in this patient population
To assess the pharmacokinetics (PK) of brentuximab vedotin
To determine the immunogenicity of brentuximab vedotin

Timepoint(s) of evaluation of this end point: - Screening
- At the End of Treatment Visit: 30 days after last dose of study drug
- During the follow up period: Every 3 months for 18 months from EOT or until the sooner of disease progression, death or study closure.Overall survival data will be collected every 3 months from EOT for 18 months, then every 6 months thereafter until the sooner of death or study closure.

Primary end point(s): Objective response rate (ORR) per independent review facility
(IRF)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: The secondary endpoints will be evaluated at the end of trial visit.

Secondary end point(s): The secondary endpoints are:
-Duration of response, PFS, CR rate, and duration of CR, by IRF assessment
Proportion of patients who receive SCT after treatment with brentuximab vedotin
-OS
-Incidence, severity, and relatedness of AEs; SAEs; and clinical laboratory
abnormalities
-PK for brentuximab vedotin, MMAE, and total antibody
-Determine the Immunogenecity

The exploratory endpoints are:
-TTP, time to response (either CR or PR), time to best response, and time to CR, by
IRF assessment
-Serum and/or plasma concentrations of serum biomarkers, sCD30, IL-6, and TARC
-B symptom resolution rate
-Health care utilization data

Secondary ID(s)

2013-000232-10-CZ

C25007

Source(s) of Monetary Support

Millennium Pharmaceuticals, Inc

Ethics review

Status: Approved
Approval date: 14/01/2014
Contact: