Peripheral T-Cell LymphomaPhase 2NCT02653976
A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
A Phase 2 study testing SP-02L (darinaparsin for injection) in people with Peripheral T-Cell Lymphoma, run by Solasia Pharma K.K. at 24 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peripheral T-Cell Lymphoma
- What is being tested?
- SP-02L (darinaparsin for injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 24 sitesin 4 countries
- Study dates
- 25 Mar 2016to 17 Jun 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
Japan12 sites
Study site
Chuo-ku, Tokyo
Study site
Fukuoka
Study site
Gifu
Study site
Isehara, Kanagawa
Study site
Koto-ku, Tokyo
Study site
Minato-ku, Tokyo
Study site
Nagoya, Aichi-ken
Study site
Okayama
Study site
Sendai, Miyagi
Study site
Suita, Osaka
Study site
Yokohama, Kanagawa
Study site
Yoshida-gun, Fukui
South Korea6 sites
Study site
Gangnam-gu, Seoul
Study site
Goyang-si, Gyeonggi-do
Study site
Hwasun-gun, Jeollanam-do
Study site
Nowon-gu, Seoul
Study site
Seodaemun-gu, Seoul
Study site
Songpa-gu, Seoul
Taiwan5 sites
Study site
Beitou, Taipei
Study site
Taichung
Study site
Tainan
Study site
Taoyuan
Study site
Zhongzheng, Taipei
About this study
Official title: Asian Multinational Phase 2 Study of SP-02L (Darinaparsin for Injection) in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
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.
- Conditions
- Peripheral T-Cell Lymphoma
- Being tested
- SP-02L (darinaparsin for injection)
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP-02L (darinaparsin for injection)Drug
Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
| Study group | Role | What they receive |
|---|---|---|
| SP-02L (darinaparsin for injection) | Experimental | Not described Receives: Drug: SP-02L (darinaparsin for injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 by individual site investigators according to the Revised Response Criteria for Malignant Lymphoma developed in 2007 based on CT and FDG-PET findings. Overall Response Rate was defined as the percentage of participants who achieved CR (disappearance of all evidence of disease) or 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 SD as their best response.
Measured: 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
Progression-Free Survival was the duration of time from the first day of study drug administration to the date of Progressive Disease (PD) based on local assessment or the date of death from any cause, which occurs earlier. PD was defined using the Revised Response Criteria for Malignant Lymphoma developed in 2007, as any new lesion or increase by ≥ 50% of previously involved sites from nadir.
Measured: 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
Overall Survival was the duration of time from the first day of study drug administration to the date of death from any cause.
Measured: 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)
AE was defined as any untoward medical occurrence in a participant administered the study drug. AE included clinically significant changes in laboratory values, vital signs, and electrocardiograms. Drug-related AE was defined as AE that there was at least a reasonable possibility to have the causal relationship to the study drug. The severity of AE was evaluated by the investigator according to Common Terminology Criteria for Adverse Events (Version 4.0) where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe or medically significant but not immediately life-threatening), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).
Measured: From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study start25 Mar 2016
- Primary completion11 Oct 2020
- Study completion17 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral T-Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solasia Pharma K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653976
- Sponsor's protocol ID
- SP-02L02
- Status last verified
- May 2023
- First submitted
- 25 Dec 2015
- Last updated
- 26 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 36661315
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asian Multinational Phase 2 Study of SP-02L (Darinaparsin for Injection) in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
- ClinicalTrials.gov ID
- NCT02653976
- Acronym / sponsor ID
- SP-02L02
- Conditions
- Peripheral T-Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Solasia Pharma K.K.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2016 (actual)
- Primary completion
- 11 Oct 2020 (actual)
- Study completion
- 17 Jun 2021 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Posted 26 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SP-02L (darinaparsin for injection) | Experimental | Drug: SP-02L (darinaparsin for injection) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SP-02L (darinaparsin for injection)Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days | Drug | SP-02L (darinaparsin for injection) |
Primary outcome
Tumor Response (Central Assessment)
Time frame: 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.
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.
4 secondary outcomes
Tumor Response (Local Assessment)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36661315Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SP-02L (darinaparsin for injection) in people with Peripheral T-Cell Lymphoma, run by Solasia Pharma K.K. at 24 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Japan, South Korea, Taiwan, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Response (Central Assessment) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02653976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.