A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
NCT ID: NCT02653976
Last Updated: 2024-01-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
67 participants
INTERVENTIONAL
2016-03-25
2021-06-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SP-02L (darinaparsin for injection)
SP-02L (darinaparsin for injection)
Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
Interventions
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SP-02L (darinaparsin for injection)
Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
Eligibility Criteria
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Inclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Solasia Pharma K.K.
INDUSTRY
Responsible Party
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Locations
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Hong Kong, , Hong Kong
Nagoya, Aichi-ken, Japan
Yoshida-gun, Fukui, Japan
Isehara, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Sendai, Miyagi, Japan
Suita, Osaka, Japan
Chuo-ku, Tokyo, Japan
Koto-ku, Tokyo, Japan
Minato-ku, Tokyo, Japan
Fukuoka, , Japan
Gifu, , Japan
Okayama, , Japan
Goyang-si, Gyeonggi-do, South Korea
Hwasun-gun, Jeollanam-do, South Korea
Gangnam-gu, Seoul, South Korea
Nowon-gu, Seoul, South Korea
Seodaemun-gu, Seoul, South Korea
Songpa-gu, Seoul, South Korea
Beitou, Taipei, Taiwan
Zhongzheng, Taipei, Taiwan
Taichung, , Taiwan
Tainan City, , Taiwan
Taoyuan District, , Taiwan
Countries
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References
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Kim WS, Fukuhara N, Yoon DH, Yamamoto K, Uchida T, Negoro E, Izutsu K, Terui Y, Nakajima H, Ando K, Suehiro Y, Kang HJ, Ko PS, Nagahama F, Sonehara Y, Nagai H, Tien HF, Kwong YL, Tobinai K. Darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: results of an Asian phase 2 study. Blood Adv. 2023 Sep 12;7(17):4903-4912. doi: 10.1182/bloodadvances.2022008615.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SP-02L02
Identifier Type: -
Identifier Source: org_study_id
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