Brentuximab Vedotin in Chinese Participants With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)

NCT02939014 | Completed Phase 2 Results

• 2 other identifiers: C25010U1111-1184-1838
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of brentuximab vedotin as a single agent in Chinese participants with relapsed/refractory CD30+ Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL).

Conditions

Hodgkin Disease; Lymphoma, Large-Cell, Anaplastic

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (4)

• Overall Response Rate (ORR)

  ORR is defined as the percentage of participants who have achieved complete remission (CR)=disappearance of all evidence of disease or partial remission (PR)=regression of greater than or equal to 50% of measurable disease and no new site by end of treatment (EOT) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

  Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment until disease progression death or end of treatment (approximately 12 months)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug.

  First dose of study drug up to 30 days after last dose of study drug (approximately 12 months)

• Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events

  Clinical Laboratory tests included tests of Chemistry, Hematology and Urinalysis prespecified in the protocol. Abnormal laboratory values assessed by the investigator that lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or were considered by the investigator to be clinically significant changes from Baseline were recorded as Adverse Events. Neutropenia (pooled) includes preferred terms Neutropenia and Neutrophil count decreased.

  First dose of study drug up to 30 days after last dose of study drug (approximately 12 months)

• Number of Participants With Abnormal Vital Signs Reported as Adverse Events

  Vital signs included blood pressure in the sitting position, pulse rate, axillary temperature and weight. Abnormal vital sign values considered by the investigator to be clinically significant were recorded as Adverse Events.

  First dose of study drug up to 30 days after last dose of study drug (approximately 12 months)

Secondary Outcomes (15)

• Complete Remission (CR) Rate

  Baseline, at Cycles (each cycle was of 3 weeks) 2, 4, 7, 10, 13, and 16 during treatment, and every 12 weeks during PFS follow-up period, until disease progression death or end of treatment (approximately 12 months)

• Duration of Response (DOR)

  Up to 3.2 years

• Progression Free Survival (PFS)

  Up to 3.2 years

• Overall Survival (OS)

  Up to 3.2 years

• B Symptom Resolution Rate

  Day 1 of each cycle (each cycle was of 3 weeks) up to 30 days after last dose of study drug (approximately 12 months)

Study Arms (1)

Brentuximab Vedotin 1.8 mg/kg

EXPERIMENTAL

Brentuximab vedotin 1.8 mg/kg, intravenous (IV) infusion on Day 1 of each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles.

Drug: Brentuximab Vedotin

Interventions

Brentuximab Vedotin DRUG

Brentuximab vedotin IV infusion

Brentuximab Vedotin 1.8 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have histologically confirmed CD30+ hodgkin lymphoma (HL) or systemic anaplastic large cell lymphoma (sALCL). Immunohistochemistry or flow cytometry may be performed on either original diagnostic biopsy material or biopsy of relapsed disease, and pathology reports of CD30+ or their copies should be retained at the site.
• With CD30+ HL or sALCL who have relapsed from or are refractory to previous treatments.
• Fluorodeoxyglucose (FDG)- positron emission tomography (PET) positive and measurable disease of at least 1.5 cm in the longest diameter by computed tomography (CT), as assessed by the site.
• Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) sampling.
• Must have the following required screening laboratory data. Participants must not have received recombinant granulocyte-colony stimulating factor (G-CSF) or platelet transfusion within 1 week before the screening hematology assessment.
• Absolute neutrophil count ≥1500/μL.
• Platelet count ≥75,000/μL.
• Serum bilirubin level ≤1.5 times the upper limit of the normal range (ULN).
• Serum creatinine level ≤1.5 times the ULN.
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the ULN.
• Survival for 3 or more months must be expected.

You may not qualify if:

• With current diagnosis of primary cutaneous anaplastic large cell lymphoma (ALCL) (participants with other organ involvement who have transformed to sALCL are eligible).
• With any active viral, bacterial, or fungal infection within 2 weeks before the first dose of brentuximab vedotin.
• With cardiac failure categorized as Class III or IV according to the New York Heart Association criteria, uncontrolled coronary artery disease or uncontrolled arrhythmia despite of appropriate medical therapy, or a history of myocardial infarction within 6 months before the first dose of brentuximab vedotin.
• With uncontrolled diabetes mellitus.
• Peripheral neuropathy ≥Grade 2.
• With a history of another 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.
• Cervical carcinoma in situ.
• With known cerebral/meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML).
• With a positive result in the screening test for human immunodeficiency virus (HIV) antibody.
• Known hepatitis B virus (HBV) surface antigen seropositive or positive hepatitis C virus (HCV) antibody. Note: participants who have positive HBV core antibody can be enrolled but must have an undetectable HBV viral load.
• With a history of liver fibrosis or cirrhosis and clinical signs and symptoms indicating liver fibrosis or cirrhosis.
• Have received autologous stem cell transplantation (auto-SCT) within 12 weeks before the first dose of brentuximab vedotin.
• With history of allogeneic stem cell transplantation (allo-SCT).

Sponsors & Collaborators

• Takeda: lead

Study Sites (7)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Sun Yat-san University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

Location

Jiangsu Province People's Hospital

Nanjing, Jiangsu, 210029, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200010, China

Location

Related Publications (1)

• Song Y, Guo Y, Huang H, Li W, Ke X, Feng J, Xu W, Miao H, Kinley J, Song G, Dai Y, Wang H, Zhu J. Phase II single-arm study of brentuximab vedotin in Chinese patients with relapsed/refractory classical Hodgkin lymphoma or systemic anaplastic large cell lymphoma. Expert Rev Hematol. 2021 Sep;14(9):867-875. doi: 10.1080/17474086.2021.1942831. Epub 2021 Aug 24.

  PMID: 34275403 DERIVED

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Large-Cell, Anaplastic

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 19, 2016
• Study Start: November 7, 2016
• Primary Completion: August 2, 2018
• Study Completion: February 3, 2020
• Last Updated: February 24, 2021
• Results First Posted: September 6, 2019

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

CN (7)