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

• Sponsor: Solasia Pharma K.K. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02653976
• Collaborator: (none)
• Enrollment: 67
• Locations: 24
• Arm: 1
• Actual Duration (Months): 62.8
• Patients Per Site: 2.8
• Patients Per Site Per Month: 0

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Mar 25, 2016
• Actual Primary Completion Date: Oct 11, 2020
• Actual Study Completion Date: Jun 17, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Tumor response [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 [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 [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 [From the date of first dosing of study drug to the completion of all follow-up procedures. Duration is approximately 6 months.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Hong Kong		Hong Kong
2		Nagoya	Aichi	Japan
3		Yoshida-gun	Fukui	Japan
4		Isehara	Kanagawa	Japan
5		Yokohama	Kanagawa	Japan
6		Sendai	Miyagi	Japan
7		Suita	Osaka	Japan
8		Chuo-ku	Tokyo	Japan
9		Koto-ku	Tokyo	Japan
10		Minato-ku	Tokyo	Japan
11		Fukuoka		Japan
12		Gifu		Japan
13		Okayama		Japan
14		Goyang-si	Gyeonggi-do	Korea, Republic of
15		Hwasun-gun	Jeollanam-do	Korea, Republic of
16		Gangnam-gu	Seoul	Korea, Republic of
17		Nowon-gu	Seoul	Korea, Republic of
18		Seodaemun-gu	Seoul	Korea, Republic of
19		Songpa-gu	Seoul	Korea, Republic of
20		Beitou	Taipei	Taiwan
21		Zhongzheng	Taipei	Taiwan
22		Taichung		Taiwan
23		Tainan		Taiwan
24		Taoyuan		Taiwan

Sponsors and Collaborators

• Solasia Pharma K.K.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Solasia Pharma K.K.
• ClinicalTrials.gov Identifier: NCT02653976
• Other Study ID Numbers: SP-02L02
• First Posted: Jan 13, 2016
• Last Update Posted: Jul 23, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral

Study Results

No Results Posted as of Jul 23, 2021