Trial · NCT02653976
A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
NCT02653976, Phase 2, Completed, Solasia Pharma K.K.; results first posted 2024-01-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL). Trials, record NCT02653976. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02653976
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
- NCT number
- NCT02653976
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 67 participants, actual
- Lead sponsor
- Solasia Pharma K.K.
- Conditions
- Peripheral T-Cell Lymphoma
- Interventions
- SP-02L (darinaparsin for injection)
- First posted
- 2016-01-13
- Last updated
- 2024-01-26
- Results first posted
- 2024-01-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tumor Response (Central Assessment) | 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. |
| Secondary | 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. | 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. |
| Secondary | 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. | 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. |
| Secondary | 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. | Overall Survival was the duration of time from the first day of study drug administration to the date of death from any cause. |
| Secondary | 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. | 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). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tumor Response (Central Assessment) | 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. | Efficacy analysis set included patients who fulfilled eligibility criteria and who took a tumor response assessment at least one time after the administration of SP-02L (darinaparsin for injection). | percentage of participants | NUMBER |
| SECONDARY | 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. | Efficacy analysis set included patients who fulfilled eligibility criteria and who took a tumor response assessment at least one time after the administration of SP-02L (darinaparsin for injection). | percentage of participants | NUMBER |
| SECONDARY | 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. | Efficacy analysis set included patients who fulfilled eligibility criteria and who took a tumor response assessment at least one time after the administration of SP-02L (darinaparsin for injection). | months | MEDIAN |
| SECONDARY | 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. | Efficacy analysis set included patients who fulfilled eligibility criteria and who took a tumor response assessment at least one time after the administration of SP-02L (darinaparsin for injection). | months | MEDIAN |
| SECONDARY | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tumor Response (Central Assessment) | SP-02L (Darinaparsin for Injection) | Overall Response Rate | 19.3 | 90% Confidence Interval 11.2 to 29.9 | percentage of participants |
| Tumor Response (Central Assessment) | SP-02L (Darinaparsin for Injection) | Disease Control Rate | 45.6 | 90% Confidence Interval 34.3 to 57.3 | percentage of participants |
| Tumor Response (Local Assessment) | SP-02L (Darinaparsin for Injection) | Overall Response Rate | 26.3 | 90% Confidence Interval 17.0 to 37.6 | percentage of participants |
| Tumor Response (Local Assessment) | SP-02L (Darinaparsin for Injection) | Disease Control Rate | 54.4 | 90% Confidence Interval 42.7 to 65.7 | percentage of participants |
| Progression-Free Survival | SP-02L (Darinaparsin for Injection) | 3.3 | 90% Confidence Interval 1.9 to 4.2 | months | |
| Overall Survival | SP-02L (Darinaparsin for Injection) | 17.4 | 90% Confidence Interval 10.3 to 23.3 | months | |
| Number of Participants With Adverse Events (AEs) | SP-02L (Darinaparsin for Injection) | AE | 64 | Participants | |
| Number of Participants With Adverse Events (AEs) | SP-02L (Darinaparsin for Injection) | Drug-related AE | 45 | Participants | |
| Number of Participants With Adverse Events (AEs) | SP-02L (Darinaparsin for Injection) | Grade ≥3 AE | 41 | Participants | |
| Number of Participants With Adverse Events (AEs) | SP-02L (Darinaparsin for Injection) | Grade ≥3 Drug-related AE | 19 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SP-02L (Darinaparsin for Injection) | 65 | |
| Overall Study | COMPLETED | SP-02L (Darinaparsin for Injection) | 56 | |
| Overall Study | NOT COMPLETED | SP-02L (Darinaparsin for Injection) | 9 |
Source ClinicalTrials.gov
Adverse events70
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | SP-02L (Darinaparsin for Injection) | 16 | 65 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | SP-02L (Darinaparsin for Injection) | 14 | 65 | |
| other | Neutropenia | Blood and lymphatic system disorders | SP-02L (Darinaparsin for Injection) | 11 | 65 | |
| other | Leukopenia | Blood and lymphatic system disorders | SP-02L (Darinaparsin for Injection) | 7 | 65 | |
| other | Lymphopenia | Blood and lymphatic system disorders | SP-02L (Darinaparsin for Injection) | 7 | 65 | |
| other | Constipation | Gastrointestinal disorders | SP-02L (Darinaparsin for Injection) | 12 | 65 | |
| other | Vomiting | Gastrointestinal disorders | SP-02L (Darinaparsin for Injection) | 7 | 65 | |
| other | Diarrhoea | Gastrointestinal disorders | SP-02L (Darinaparsin for Injection) | 6 | 65 | |
| other | Nausea | Gastrointestinal disorders | SP-02L (Darinaparsin for Injection) | 5 | 65 | |
| other | Pyrexia | General disorders | SP-02L (Darinaparsin for Injection) | 24 | 65 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SP-02L (Darinaparsin for Injection) | 6 | 65 |
| Total, other adverse events | SP-02L (Darinaparsin for Injection) | 64 | 65 |
| Total, serious adverse events | SP-02L (Darinaparsin for Injection) | 30 | 65 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36661315 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02653976
GET https://conductscience.org/api/trials/v1/NCT02653976/events?page=2