NCT02653976

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_2

Geographic Reach
4 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 25, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2021

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

January 26, 2024

Completed
Last Updated

January 26, 2024

Status Verified

May 1, 2023

Enrollment Period

4.6 years

First QC Date

December 25, 2015

Results QC Date

July 1, 2022

Last Update Submit

May 15, 2023

Conditions

Peripheral T-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Tumor Response (Central Assessment)

    Central assessments of tumor response were performed by the Efficacy and Safety review Committee according to the Revised Response Criteria for Malignant Lymphoma developed in 2007 based on computed tomography (CT) and fluorodeoxyglucose-positron emission tomography (FDG-PET) findings. Overall Response Rate was defined as the percentage of participants who achieved Complete Response (CR, disappearance of all evidence of disease) or Partial Response (PR, regression of measurable disease and no new sites) as their best response. Disease Control Rate is defined as the percentage of participants who achieved CR, PR or Stable Disease (SD) as their best response.

    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 (4)

  • Tumor Response (Local Assessment)

    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.

  • Progression-Free Survival

    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.

  • Overall Survival

    Survival follow-up was performed for 2 years from the date of first dosing of study drug. Maximum duration was 24.9 months.

  • Number of Participants With Adverse Events (AEs)

    From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.

Study Arms (1)

SP-02L (darinaparsin for injection)

EXPERIMENTAL
Drug: SP-02L (darinaparsin for injection)

Interventions

SP-02L (darinaparsin for injection)DRUG

Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days

SP-02L (darinaparsin for injection)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Unknown Facility

Hong Kong, Hong Kong

Location

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Yoshida-gun, Fukui, Japan

Location

Unknown Facility

Isehara, Kanagawa, Japan

Location

Unknown Facility

Yokohama, Kanagawa, Japan

Location

Unknown Facility

Sendai, Miyagi, Japan

Location

Unknown Facility

Suita, Osaka, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, Japan

Location

Unknown Facility

Koto-ku, Tokyo, Japan

Location

Unknown Facility

Minato-ku, Tokyo, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Gifu, Japan

Location

Unknown Facility

Okayama, Japan

Location

Unknown Facility

Goyang-si, Gyeonggi-do, South Korea

Location

Unknown Facility

Hwasun-gun, Jeollanam-do, South Korea

Location

Unknown Facility

Gangnam-gu, Seoul, South Korea

Location

Unknown Facility

Nowon-gu, Seoul, South Korea

Location

Unknown Facility

Seodaemun-gu, Seoul, South Korea

Location

Unknown Facility

Songpa-gu, Seoul, South Korea

Location

Unknown Facility

Beitou, Taipei, Taiwan

Location

Unknown Facility

Zhongzheng, Taipei, Taiwan

Location

Unknown Facility

Taichung, Taiwan

Location

Unknown Facility

Tainan, Taiwan

Location

Unknown Facility

Taoyuan District, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 36661315DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

darinaparsinInjections

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Results Point of Contact

Title
Clinical Development Department
Organization
Solasia Pharma K.K.
clinicaldev@solasia.co.jp
+81358438045

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2015

First Posted

January 13, 2016

Study Start

March 25, 2016

Primary Completion

October 11, 2020

Study Completion

June 17, 2021

Last Updated

January 26, 2024

Results First Posted

January 26, 2024

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

JP(12)TW(5)HK(1)KR(6)