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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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).

Detailed Summary:

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.

Current Primary Outcome:

• 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.
• 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.
• 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.
• 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.
• 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.
• 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.
• 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.
• 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.
• 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 ]
• 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 ]
• 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 ]
• Number of Participants with Antitherapeutic Antibodies (ATA) and Neutralizing Antitherapeutic Antibodies (nATA) to Brentuximab Vedotin [ Time Frame: Up to 1 year ]

Original Secondary Outcome: Same as current

Information By: Takeda

Dates:
Date Received: October 18, 2016
Date Started: November 30, 2016
Date Completion: April 30, 2020
Last Updated: April 20, 2017
Last Verified: April 2017