Phase 4 Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma

• Register: EUCTR
• Last refreshed on: 2 March 2022
• Main ID: EUCTR2012-004128-39-BE
• Date of registration: 29/04/2013
• Prospective Registration: Yes
• Primary sponsor: Takeda Development Center (TDC) Americas, Inc.
• Public title: Phase 4 Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
• Scientific title: A Phase 4, Open–label, Single-Arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
• Date of first enrolment: 10/07/2013
• Target sample size: 45
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004128-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; 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

Belgium, Croatia, Czech Republic, Czechia, Hungary, Poland, Portugal, Romania, Spain, Turkey, United Kingdom

Contacts

• Name: Drug Information Call Centre
• Affiliation: Takeda Development Center (TDC) Americas, Inc.

• Name: Drug Information Call Centre
• Affiliation: Takeda Development Center (TDC) Americas, Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
- Patients with relapsed or refractory sALCL who have previously received at least 1 multiagent chemotherapy (CHOP or equivalent multiagent chemotherapy regimen with curative intent).
- Histologically-confirmed sALCL based on local pathology report. If archived tissue cannot be obtained, a biopsy should be performed at screening.
- Age greater than or equal to 18 years.
- Patients must have bidimensional measurable disease of = 1.5 cm as documented by radiographic technique (spiral CT preferred) per the International Working Group Revised Criteria for Response Assessment for Malignant Lymphoma.
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 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion criteria:
1. Previous treatment with brentuximab vedotin.
2. Previously received an allogeneic transplant.
3. Patients with current diagnosis of primary cutaneous ALCL (patients whose ALCL has transformed to sALCL are eligible).
4. Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:
• Myocardial infarction within 6 months before the first dose of
study drug
• New York Heart Association (NYHA) Class III or IV heart failure
(Refer to Section 15.2).
• Evidence of current uncontrolled cardiovascular conditions,
including cardiac arrhythmias, congestive heart failure (CHF),
angina, or electrocardiographic evidence of acute ischemia or
active conduction system abnormalities
5. History of another primary malignancy that has not been in remission for at least 3 years. The following are exempt from the 3-year limits: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.
6. Any active uncontrolled systemic viral, bacterial, or fungal infection
7. Any antimicrobial, antiviral, or antifungal therapy within 1 week prior to the first dose of brentuximab vedotin (routine prophylaxis is acceptable)
8. Treatment with any investigational products within 4 weeks before the first dose of study drug
9. Current therapy with other systemic anti-neoplastic or investigational agents.
10. Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML).
11. Female patients who are lactating and breastfeeding or have a positive serum or urine pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug.
12. Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent.
13. Known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation.
14. Known human immunodeficiency virus (HIV) positive.
15. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.


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

Health Condition(s) or Problem(s) studied

Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
MedDRA version: 20.0 Level: HLT Classification code 10002235 Term: Anaplastic large cell lymphomas T- and null-cell types System Organ Class: 100000004851

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)

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

Main Objective: To assess the antitumor efficacy of single-agent brentuximab vedotin (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate (ORR) in patients with relapsed or refractory sALCL following at least 1 multiagent chemotherapy (CHOP or equivalent multiagent chemotherapy regimens with curative intent)

Secondary Objective: - To determine duration of tumor control, including duration of response, progression-free survival, and complete remission rate with brentuximab vedotin.
- To determine the percentage of patients receiving hematopoietic stem cell transplant (either autologous or allogeneic) after brentuximab vedotin therapy.
- To determine overall survival with brentuximab vedotin.
- To assess the safety and tolerability of brentuximab vedotin.
- To assess the pharmacokinetics 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.

Secondary Outcome(s)

Secondary end point(s): - Duration of response per IRF
- Progression-free survival (PFS) per IRF
- Complete remission (CR) rate per IRF
- Percentage of patients receiving hematopoietic stem cell transplant (SCT) following treatment with brentuximab vedotin
- Overall survival (OS)
- Type, incidence, severity, seriousness, and relatedness of adverse events, and laboratory abnormalities
- Selected pharmacokinetic parameters
- The presence of anti-therapeutic antibodies (ATA) to brentuximab vedotin

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

Secondary ID(s)

C25006

2012-004128-39-GB

Source(s) of Monetary Support

Takeda Development Center (TDC) Americas, Inc.

Ethics review

Status: Approved
Approval date: 10/07/2013
Contact: