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

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ClinicalTrials.gov Identifier: NCT02939014
Recruitment Status : Active, not recruiting
First Posted : October 19, 2016
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

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).

Condition or disease Intervention/treatment Phase
Hodgkin Disease Lymphoma, Large-Cell, Anaplastic Drug: Brentuximab Vedotin Phase 2

Detailed Description:

The drug being tested in this study is called brentuximab vedotin. This study will look at efficacy, safety and PK of brentuximab vedotin in Chinese participants with relapsed/refractory CD30+ HL or sALCL.

The study will enroll approximately 30 patients. Participants will receive:

• Brentuximab vedotin 1.8 mg/kg

All participants will be administered IV infusion on Day 1 each 3-week cycle until the sooner of disease progression, unacceptable toxicity, or completion of 16 cycles.

This multi-center trial will be conducted in China only. The overall time to participate in this study is 3.5 years. Participants will make multiple visits to the clinic, and will be followed for overall survival (OS) every 12 weeks until death, withdrawal of consent, 18 months after end of treatment (EOT) or study closure, whichever occurs first.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Single-Arm, Open-label Study of Brentuximab Vedotin in Chinese Patients With Relapsed/Refractory CD30-Positive Hodgkin Lymphoma (HL) or Systemic Anaplastic Large Cell Lymphoma (sALCL)
Actual Study Start Date : November 30, 2016
Actual Primary Completion Date : August 2, 2018
Estimated Study Completion Date : December 1, 2019


Arm Intervention/treatment
Experimental: Brentuximab Vedotin 1.8 mg/kg
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
Brentuximab vedotin IV infusion.




Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to 1 year ]
    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 sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

  2. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 30 days after last dose of study drug (approximately 1 year) ]
    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 after receiving study drug.

  3. Number of Participants with Abnormal Clinical Laboratory Findings [ Time Frame: Up to 1 year ]
    The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.

  4. Number of Participants With Abnormal Vital Sign [ Time Frame: Up to 1 year ]
    Vital signs will include blood pressure in the sitting position, pulse rate, and axillary temperature.


Secondary Outcome Measures :
  1. Complete Remission (CR) Rate [ Time Frame: Up to 1 year ]
    The CR rate is defined as the percentage of participants who have achieved CR. CR is defined as disappearance of all evidence of disease.

  2. Duration of Response (DOR) [ Time Frame: Up to 3.5 years ]
    DOR is defined as the time between the first documentation of objective tumor response (CR or PR) and the first subsequent documentation of objective tumor progression or death due to any cause, whichever occurs first. CR is defined as disappearance of all evidence of disease. PR is defined as regression of greater than or equal to 50% of measurable disease and no new sites.

  3. Progression Free Survival (PFS) [ Time Frame: Up to 3.5 years ]
    PFS is defined as the time from the start of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.

  4. Overall Survival (OS) [ Time Frame: Up to 3.5 years ]
    Overall survival is defined as the time from the start of treatment to the date of death.

  5. B Symptom Resolution Rate [ Time Frame: Up to 1 year ]
    Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.

  6. Cmax: Maximum Observed Plasma Concentration for Brentuximab Vedotin [ Time Frame: Cycles 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose, Cycle 3 and every 2 cycles afterwards: Day 1 pre-dose and up to 10 minutes post dose ]
  7. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Brentuximab Vedotin [ Time Frame: Cycles 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose, Cycle 3 and every 2 cycles afterwards: Day 1 pre-dose and up to 10 minutes post dose ]
  8. AUC(0-∞): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for Brentuximab Vedotin [ Time Frame: Cycles 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose, Cycle 3 and every 2 cycles afterwards: Day 1 pre-dose and up to 10 minutes post dose ]
  9. Number of Participants with Antitherapeutic Antibodies (ATA) and Neutralizing Antitherapeutic Antibodies (nATA) to Brentuximab Vedotin [ Time Frame: Up to 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. With CD30+ HL or sALCL who have relapsed from or are refractory to previous treatments.
  3. 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.
  4. Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  5. Suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) sampling.
  6. 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.

    1. Absolute neutrophil count ≥1500/μL.
    2. Platelet count ≥75,000/μL.
    3. Serum bilirubin level ≤1.5 times the upper limit of the normal range (ULN).
    4. Serum creatinine level ≤1.5 times the ULN.
    5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the ULN.
  7. Survival for 3 or more months must be expected.

Exclusion Criteria:

  1. With current diagnosis of primary cutaneous anaplastic large cell lymphoma (ALCL) (participants with other organ involvement who have transformed to sALCL are eligible).
  2. With any active viral, bacterial, or fungal infection within 2 weeks before the first dose of brentuximab vedotin.
  3. 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.
  4. With uncontrolled diabetes mellitus.
  5. Peripheral neuropathy ≥Grade 2.
  6. 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:

    1. Nonmelanoma skin cancer.
    2. Curatively treated localized prostate cancer.
    3. Cervical carcinoma in situ.
  7. With known cerebral/meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML).
  8. With a positive result in the screening test for human immunodeficiency virus (HIV) antibody.
  9. 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.
  10. With a history of liver fibrosis or cirrhosis and clinical signs and symptoms indicating liver fibrosis or cirrhosis.
  11. Have received autologous stem cell transplantation (auto-SCT) within 12 weeks before the first dose of brentuximab vedotin.
  12. With history of allogeneic stem cell transplantation (allo-SCT).
  13. Have received treatment for malignancies (including radiation, chemotherapy, and hormone therapy) within 4 weeks before the first dose of brentuximab vedotin and participants who have received treatment for malignancies with biologics (including molecular target drug) or radioisotopic therapy within 12 weeks before the first dose of brentuximab vedotin.
  14. Have unresolved toxicity higher than Grade 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03) attributed to any prior therapy/procedure (excluding alopecia or non-clinically significant and asymptomatic laboratory abnormalities).
  15. Have received systemic corticosteroids at doses greater than the equivalent of 20 mg/day of prednisone within 1 week before the first dose of brentuximab vedotin.
  16. Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of the safety and toxicity of the prescribed regimens.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939014


Locations
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China, Beijing
Beijing, Beijing, China
China, Guangdong
Guangzhou, Guangdong, China
China, Jiangsu
Nanjing, Jiangsu, China
China, Jilin
Changchun, Jilin, China
China, Shanghai
Shanghai, Shanghai, China
China, Tianjin
Tianjin, Tianjin, China
China, Zhejiang
Hangzhou, Zhejiang, China
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Clinical Science Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02939014     History of Changes
Other Study ID Numbers: C25010
U1111-1184-1838 ( Other Identifier: WHO )
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs