CD30 positive cHL or sALCL
Conditions
Interventions
investigational material(s)
Generic name etc : Brentuximab Vedotin (Genetical Recombination)
INN of investigational material : brentuximab vedotin
Therapeutic category code : 429 Other antitumor agent
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) cHL or sALCL patients with CD30 positive (2) Patients who previously experienced a CR or PR with first brentuximab vedotin treatment and subsequently experienced disease progression or relapse were administered brentuximab vedotin retreatment*. *Definition of brentuximab vedotin retreatment 1) Discontinued treatment of brentuximab vedotin as prior therapy after experienced a CR or PR. 2) At least single dose of brentuximab vedotin was administered after discontinued treatment of brentuximab vedotin and subsequently experienced disease progression or relapse. 3) Treatment of brentuximab vedotin after 6 weeks or more passed from the date of final dose of prior treatment of brentuximab vedotin. 4) Not the treatment of brentuximab vedotin as consolidation after SCT (stem cell transplantation). 5) Monotherapy of retreatment of brentuximab vedotin (not concomitant use with other antitumor agent) 6) Re-retreatment (in the case that retreatment of brentuximab vedotin was administered after discontinued retreatment of brentuximab vedotin described above) is handled as a set of retreatment). (3) A patient who agreed with informed consent prior to the study enrollment.
Exclusion criteria
Exclusion criteria: (1) Patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study (such as patients who may be coerced to give consent)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Number of Participants who Experience at least one Treatment-Emergent Adverse Events (TEAE) Timeframe: From initiation of Brentuximab vedotin retreatment up to 4 weeks after discontinuation of Brentuximab vedotin retreatment or initiation of follow-up treatment, whichever date is earlier, or until the date of informed consent. In the case that retreatment is still continued or it is within 4 weeks from discontinuation of retreatment at the informed consent, adverse events should be collected until the date of informed consent (Up to 12 Month as a maximum) An 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. A TEAE is defined as an AE that has developed from the initiation of brenzuximab vedotin retreatment to the end of retreatment. efficacy Objective Response Rate (ORR) Timeframe: From the initiation of brentuximab vedotin retreatment to discontinuation or end of therapy, or until the informed consent date if the retreatment is continued (Up to 12 Month as a maximum) ORR is defined as the sum of percentage of participants whose best overall response from initiation of brentuximab vedotin retreatment to the discontinuation or end of treatment according to response criteria is either CR, complete response/unconfirmed (CRu) or PR. Overall response will be graded by favorability in the order of CR, CRu, PR, stable disease (SD), PD, and NE. Best overall response is the best response recorded. Response and progression is evaluated by Revised Response Criteria for Malignant Lymphoma by Cheson. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Complete response rate (CR rate) Timeframe: From the initiation of brentuximab vedotin retreatment to discontinuation or end of therapy, or until the informed consent date if the retreatment is continued. (Up to 12 Month as a maximum) CR rate is defined as the sum of percentage of participants confirmed CR or CRu Response and progression is evaluated by Revised Response Criteria for Malignant Lymphoma by Cheson. efficacy Progression-Free Survival (PFS) Timeframe: From the day of enrollment until the day of documented progression or the day of death due to all causes whichever comes earlier. (Up to 12 Month as a maximum) PFS is defined as the period from the day of enrollment until the day of documented progression or the day of death due to all causes whichever comes earlier. Response and progression is evaluated by Revised Response Criteria for Malignant Lymphoma by Cheson. efficacy Duration of Response (DOR) Timeframe: From the day when either CR/CRu or PR is first confirmed until the day of documented progression or the day of death due to all causes, whichever occurs earlier. (Up to 12 Month as a maximum) DOR is defined as the period from the day when either CR/CRu or PR is first confirmed until the day of documented progression or the day of death due to all causes, whichever occurs earlier. Response and progression is evaluated by Revised Response Criteria for Malignant Lymphoma by Cheson. efficacy Time to treatment failure (TTF) Timeframe: From the day of enrollment until the day of the decision to discontinue brentuximab vedotin retreatment, the day of documented progression during brentuximab vedotin retreatment, or the day of death due to all causes whichever comes earlier. (Up to 12 Month as a maximum) TTF is defined as the period from the day of enrollment until the day of the decision to discontinue brentuximab vedotin retreatment, the day of documented progression during brentuximab vedotin retreatment, or the day of death due to all causes | — |
Countries
Japan
Outcome results
None listed