Clinical trial NCT02653976: A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Official title: Asian Multinational Phase 2 Study of SP-02L (Darinaparsin for Injection) in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral T-Cell Lymphoma
Lead sponsor: Solasia Pharma K.K.
Sponsor class: INDUSTRY
First posted: 2016-01-13
Enrollment: 67
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a phase 2 multinational, multicenter, single-arm, open-label, non-randomized study to evaluate the efficacy and safety of SP-02L monotherapy in relapsed or refractory patients with peripheral T-cell lymphoma.


Eligibility criteria: Inclusion Criteria:

* Patients with a Japanese, Korean, Taiwanese, or Chinese ethnic background of each country/region
* Patients aged ≥20 years on the date of informed consent
* Patients with histologically confirmed diagnosis of one of the following:

  * Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
  * Angioimmunoblastic T-cell Lymphoma (AITL)
  * Anaplastic large cell lymphoma (ALCL), (ALK-positive/negative)
* Relapsed or refractory patients with a treatment history of at least one regimen with antitumor agents for the above disease
* Have at least 1 measurable lesion
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Patients with a life expectancy of at least 3 months as determined by the investigator

Primary outcomes:
measure: Tumor Response (Central Assessment)
timeFrame: Central assessments of tumor response were performed every 3 cycles, and/or at the end of treatment visit, during 6-cycle treatment period. The best response was determined during 6-cycle treatment period. Maximum duration of assessments was 5.3 months.
Secondary outcomes:
measure: Tumor Response (Local Assessment)
timeFrame: Local assessments of tumor response were performed at the end of every 3 cycles, and/or at the end of treatment visit. The best response was determined during the entire treatment period. Maximum duration of assessments was 42.4 months.
measure: Progression-Free Survival
timeFrame: Tumor response was assessed at the end of every 3 cycles until documented PD. Maximum duration as of the cut-off date for data lock was 42.4 months.
measure: Overall Survival
timeFrame: Survival follow-up was performed for 2 years from the date of first dosing of study drug. Maximum duration was 24.9 months.
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
city: Nagoya
country: Japan
state: Aichi
city: Yoshida-gun
country: Japan
state: Fukui
city: Isehara
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Sendai
country: Japan
state: Miyagi
city: Suita
country: Japan
state: Osaka
city: Chuo-ku
country: Japan
state: Tokyo
city: Koto-ku
country: Japan
state: Tokyo
city: Minato-ku
country: Japan
state: Tokyo
city: Fukuoka
country: Japan
city: Gifu
country: Japan
city: Okayama
country: Japan
city: Goyang-si
country: Korea, Republic of
state: Gyeonggi-do
city: Hwasun-gun
country: Korea, Republic of
state: Jeollanam-do
city: Gangnam-gu
country: Korea, Republic of
state: Seoul
city: Nowon-gu
country: Korea, Republic of
state: Seoul
city: Seodaemun-gu
country: Korea, Republic of
state: Seoul
city: Songpa-gu
country: Korea, Republic of
state: Seoul
city: Beitou
country: Taiwan
state: Taipei
city: Zhongzheng
country: Taiwan
state: Taipei
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taoyuan
country: Taiwan
Study officials:
References: