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A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02653976
Recruitment Status : Active, not recruiting
First Posted : January 13, 2016
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Solasia Pharma K.K.

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.

Condition or disease Intervention/treatment Phase
Peripheral T-Cell Lymphoma Drug: SP-02L (darinaparsin for injection) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Asian Multinational Phase 2 Study of SP-02L (Darinaparsin for Injection) in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Actual Study Start Date : March 25, 2016
Actual Primary Completion Date : October 11, 2020
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: SP-02L (darinaparsin for injection) Drug: SP-02L (darinaparsin for injection)
Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days




Primary Outcome Measures :
  1. Tumor response [ Time Frame: Change from screening period in tumor response assessed at the end of every 3 cycles from the date of first dosing of study drug, and at the end of treatment visit. Duration is approximately 6 months. ]

Secondary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: Change from screening period in tumor response assessed at the end of every 3 cycles from the date of first dosing of study drug, and every 3 months after the end of treatment visit until documented disease progression. Duration is approximately 1 year. ]
  2. Overall Survival [ Time Frame: Survival follow-up from the date of first dosing of study drug until the date of death from any cause, assessed up to 2 years. ]
  3. Incidence of all adverse events including clinically significant changes in laboratory values and vital sign measurements [ Time Frame: From the date of first dosing of study drug to the completion of all follow-up procedures. Duration is approximately 6 months. ]


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

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): NCT02653976


Locations
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Hong Kong
Hong Kong, Hong Kong
Japan
Nagoya, Aichi, 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
Korea, Republic of
Goyang-si, Gyeonggi-do, Korea, Republic of
Hwasun-gun, Jeollanam-do, Korea, Republic of
Gangnam-gu, Seoul, Korea, Republic of
Nowon-gu, Seoul, Korea, Republic of
Seodaemun-gu, Seoul, Korea, Republic of
Songpa-gu, Seoul, Korea, Republic of
Taiwan
Beitou, Taipei, Taiwan
Zhongzheng, Taipei, Taiwan
Taichung, Taiwan
Tainan, Taiwan
Taoyuan, Taiwan
Sponsors and Collaborators
Solasia Pharma K.K.
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Responsible Party: Solasia Pharma K.K.
ClinicalTrials.gov Identifier: NCT02653976    
Other Study ID Numbers: SP-02L02
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin