Trial Outcomes & Findings for A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) (NCT NCT02653976)
NCT ID: NCT02653976
Last Updated: 2024-01-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
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.
Results posted on
2024-01-26
Participant Flow
Patients were recruited in Japan, Korea, Taiwan and Hong Kong during the period from March 25, 2016 to September 17, 2019.
67 patients were enrolled and 65 were treated.
Participant milestones
| Measure |
SP-02L (Darinaparsin for Injection)
SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
SP-02L (Darinaparsin for Injection)
SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Death
|
4
|
Baseline Characteristics
A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Baseline characteristics by cohort
| Measure |
SP-02L (Darinaparsin for Injection)
n=65 Participants
SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
|
|---|---|
|
Age, Continuous
|
68.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
1 Participants
n=5 Participants
|
|
Histopathological Diagnosis
Peripheral T-cell lymphoma not otherwise specified
|
43 Participants
n=5 Participants
|
|
Histopathological Diagnosis
Angioimmunoblastic T-cell Lymphoma
|
17 Participants
n=5 Participants
|
|
Histopathological Diagnosis
Anaplastic large cell lymphoma, ALK-negative
|
3 Participants
n=5 Participants
|
|
Histopathological Diagnosis
Anaplastic large cell lymphoma, ALK-positive
|
0 Participants
n=5 Participants
|
|
Histopathological Diagnosis
Other
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.Population: 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).
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.
Outcome measures
| Measure |
SP-02L (Darinaparsin for Injection)
n=57 Participants
SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
|
|---|---|
|
Tumor Response (Central Assessment)
Overall Response Rate
|
19.3 percentage of participants
Interval 11.2 to 29.9
|
|
Tumor Response (Central Assessment)
Disease Control Rate
|
45.6 percentage of participants
Interval 34.3 to 57.3
|
SECONDARY outcome
Timeframe: 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.Population: 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).
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.
Outcome measures
| Measure |
SP-02L (Darinaparsin for Injection)
n=57 Participants
SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
|
|---|---|
|
Tumor Response (Local Assessment)
Overall Response Rate
|
26.3 percentage of participants
Interval 17.0 to 37.6
|
|
Tumor Response (Local Assessment)
Disease Control Rate
|
54.4 percentage of participants
Interval 42.7 to 65.7
|
SECONDARY outcome
Timeframe: 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.Population: 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).
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.
Outcome measures
| Measure |
SP-02L (Darinaparsin for Injection)
n=57 Participants
SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
|
|---|---|
|
Progression-Free Survival
|
3.3 months
Interval 1.9 to 4.2
|
SECONDARY outcome
Timeframe: Survival follow-up was performed for 2 years from the date of first dosing of study drug. Maximum duration was 24.9 months.Population: 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).
Overall Survival was the duration of time from the first day of study drug administration to the date of death from any cause.
Outcome measures
| Measure |
SP-02L (Darinaparsin for Injection)
n=57 Participants
SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
|
|---|---|
|
Overall Survival
|
17.4 months
Interval 10.3 to 23.3
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
SP-02L (Darinaparsin for Injection)
n=65 Participants
SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
AE
|
64 Participants
|
|
Number of Participants With Adverse Events (AEs)
Drug-related AE
|
45 Participants
|
|
Number of Participants With Adverse Events (AEs)
Grade ≥3 AE
|
41 Participants
|
|
Number of Participants With Adverse Events (AEs)
Grade ≥3 Drug-related AE
|
19 Participants
|
Adverse Events
SP-02L (Darinaparsin for Injection)
Serious events: 30 serious events
Other events: 64 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
SP-02L (Darinaparsin for Injection)
n=65 participants at risk
SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
|
|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
General disorders
Disease progression
|
10.8%
7/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
General disorders
Pyrexia
|
7.7%
5/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
General disorders
Fatigue
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
General disorders
Hypothermia
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
2/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Gastrointestinal disorders
Dysphagia
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Ear and labyrinth disorders
Vertigo
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Hepatobiliary disorders
Biliary fistula
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Immune system disorders
Anaphylactic shock
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Infections and infestations
Bacteraemia
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Infections and infestations
Device related sepsis
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Infections and infestations
Enterobacter infection
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Infections and infestations
Epiglottitis
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Infections and infestations
Herpes zoster
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Infections and infestations
Pharyngitis
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Infections and infestations
Pneumonia
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Infections and infestations
Respiratory tract infection
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Infections and infestations
Septic shock
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Infections and infestations
Sinusitis
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Nervous system disorders
Cerebral infarction
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Psychiatric disorders
Confusional state
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Vascular disorders
Deep vein thrombosis
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Vascular disorders
Peripheral ischaemia
|
1.5%
1/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
Other adverse events
| Measure |
SP-02L (Darinaparsin for Injection)
n=65 participants at risk
SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
24.6%
16/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
21.5%
14/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.9%
11/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.8%
7/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.8%
7/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Gastrointestinal disorders
Constipation
|
18.5%
12/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Gastrointestinal disorders
Vomiting
|
10.8%
7/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.2%
6/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
5/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
General disorders
Pyrexia
|
36.9%
24/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
General disorders
Malaise
|
13.8%
9/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
General disorders
Fatigue
|
9.2%
6/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Infections and infestations
Nasopharyngitis
|
9.2%
6/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.2%
6/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Injury, poisoning and procedural complications
Fall
|
9.2%
6/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Investigations
Aspartate aminotransferase increased
|
18.5%
12/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Investigations
Alanine aminotransferase increased
|
15.4%
10/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.5%
12/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.8%
7/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.8%
7/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.7%
5/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.2%
4/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.2%
4/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Nervous system disorders
Dizziness
|
7.7%
5/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Nervous system disorders
Headache
|
7.7%
5/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.7%
5/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Nervous system disorders
Dysgeusia
|
6.2%
4/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Psychiatric disorders
Delirium
|
12.3%
8/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Psychiatric disorders
Insomnia
|
6.2%
4/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.2%
4/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.4%
10/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.8%
7/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
|
Vascular disorders
Hypertension
|
6.2%
4/65 • From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place