Clinical Trials List
Protocol NumberSP-02L02
NCT Number(ClinicalTrials.gov Identfier)NCT02653976
2017-03-01 - 2019-09-30
Phase II
Terminated5
ICD-10C84.48
Peripheral T-cell lymphoma, not classified, lymph nodes of multiple sites
Asian Multinational Phase 2 Study of SP-02L (Darinaparsin for Injection) in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
-
Trial Applicant
PROTECH PHARMASERVICES CORPORATION
-
Sponsor
Solasia Pharma K.K.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Jyh-Pyng Gau Division of Hematology & Oncology
- 黃文盛 Division of Hematology & Oncology
- Liang-Tsai Hsiao Division of Hematology & Oncology
- 陳健翎 Division of Hematology & Oncology
- Hao-Yuan Wang Division of Hematology & Oncology
- Tzeon-jye Chiou Division of Hematology & Oncology
- Sheng-Hsuan Chien Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Ming-Yu Lien Division of Hematology & Oncology
- Ching-Chan Lin Division of Hematology & Oncology
- Ming-Hung Tsai Division of Hematology & Oncology
- Che-Hung Lin Division of Hematology & Oncology
- Ching Yun Hsieh Division of Hematology & Oncology
- Tzu-Ting Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Ya-Ting Hsu Division of Hematology & Oncology
- 蔡依珊 Division of Hematology & Oncology
- Wei-Pang Chung Division of Hematology & Oncology
- Ya-Ping Chen Division of Hematology & Oncology
- 劉奕廷 Division of Hematology & Oncology
- Sin-Syue Li Division of Hematology & Oncology
- Nan-Tsing Chiu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Tung-Liang Lin Division of Hematology & Oncology
- 高小雯 Division of Hematology & Oncology
- Ming-Chung Kao Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
- Jih-Luh Tang Division of General Internal Medicine
- Tai-Chung Huang Division of General Internal Medicine
- 劉高郎 Division of General Internal Medicine
- MING YAO Division of General Internal Medicine
- Huai-Hsuan Huang Division of General Internal Medicine
- - - Division of General Internal Medicine
- 李啟承 Division of General Internal Medicine
- CHENG-HONG TSAI Division of General Internal Medicine
- - - Division of General Internal Medicine
- Chieh-Lung Cheng Division of General Internal Medicine
- RUOH-FANG YEN Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Objectives
[Primary Objective]To evaluate the efficacy of SP-02L monotherapy in patients with relapsed orrefractory PTCL[Secondary Objectives] -To evaluate the safety of SP-02L monotherapy in patients with relapsed orrefractory PTCL -To assess the pharmacokinetic (PK) profile of SP-02L at multiple doses in asubgroup of subjects
Test Drug
SP-02L
Active Ingredient
darinaparsin
Dosage Form
Injection
Dosage
150
Endpoints
[Primary Endpoint]
Tumor response (best overall response) according to the Revised Response
Criteria for Malignant Lymphoma by an International Working Group to
Standardize Response Criteria for Non-Hodgkin's Lymphomas in 2007
[Secondary Endpoints]
-Progression-free survival (PFS), time to response (TTR), duration of
response (DOR) and overall survival (OS)
-Occurrence of adverse events (AEs)
-Drug plasma concentration-time profile, PK parameters, and urinary
excretion rates
Tumor response (best overall response) according to the Revised Response
Criteria for Malignant Lymphoma by an International Working Group to
Standardize Response Criteria for Non-Hodgkin's Lymphomas in 2007
[Secondary Endpoints]
-Progression-free survival (PFS), time to response (TTR), duration of
response (DOR) and overall survival (OS)
-Occurrence of adverse events (AEs)
-Drug plasma concentration-time profile, PK parameters, and urinary
excretion rates
Inclution Criteria
[Inclusion criteria]
(1) Patients with ethnic background of each participating country/region;
(2) Patients aged ≥ 20 years of age at the date of obtaining informed consent;
(3) Patients with histopathologically 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);
The pathology specimens supporting the local diagnosis should be
submitted for the central pathology review by the Pathological Review
Committee.
(4) Patients have a treatment history of at least one regimen with antitumor
agents for the above diseases;
(5) Patients have an enlarged lymph node or extranodal mass lesion that is
measurable on computed tomography (CT);
In this study, a measurable enlarged lymph node is defined as a lesion of
> 1.5 cm in greatest transverse diameter regardless of short axis
measurement or > 1.0 cm in short axis regardless of greatest transverse
diameter, that is clearly measurable in 2 perpendicular dimensions. A
measurable extranodal mass lesion is defined as a lesion of ≥ 1.0 cm in
greatest transverse diameter (two times longer than the scan slice
thickness). A nodular mass within the liver or spleen is defined as a
space-occupying lesion of ≥ 1.0 cm in 2 perpendicular dimensions.
(6) Patients with Eastern Cooperative Oncology Group Performance Status
(ECOG-PS) of 0, 1, or 2; and
(7) Patients with a life expectancy of at least 3 months (e.g. no acute
exacerbation of their primary disease) as determined by the principal
investigator or sub-investigator.
(1) Patients with ethnic background of each participating country/region;
(2) Patients aged ≥ 20 years of age at the date of obtaining informed consent;
(3) Patients with histopathologically 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);
The pathology specimens supporting the local diagnosis should be
submitted for the central pathology review by the Pathological Review
Committee.
(4) Patients have a treatment history of at least one regimen with antitumor
agents for the above diseases;
(5) Patients have an enlarged lymph node or extranodal mass lesion that is
measurable on computed tomography (CT);
In this study, a measurable enlarged lymph node is defined as a lesion of
> 1.5 cm in greatest transverse diameter regardless of short axis
measurement or > 1.0 cm in short axis regardless of greatest transverse
diameter, that is clearly measurable in 2 perpendicular dimensions. A
measurable extranodal mass lesion is defined as a lesion of ≥ 1.0 cm in
greatest transverse diameter (two times longer than the scan slice
thickness). A nodular mass within the liver or spleen is defined as a
space-occupying lesion of ≥ 1.0 cm in 2 perpendicular dimensions.
(6) Patients with Eastern Cooperative Oncology Group Performance Status
(ECOG-PS) of 0, 1, or 2; and
(7) Patients with a life expectancy of at least 3 months (e.g. no acute
exacerbation of their primary disease) as determined by the principal
investigator or sub-investigator.
Exclusion Criteria
[Exclusion Criteria]
(1) Patient with inadequately maintained major organ functions as evidenced by
the following laboratory test values taken at the screening visit. These
laboratory test values should not be affected by blood transfusion or
administration of hematopoietic growth factor agents, etc. Even though the
patients who meet none of the following criteria, subject’s condition should
not show an obvious tendency toward worsening as determined by the
principal investigator or sub-investigator:
・ Electrocardiogram (ECG): Fridericia-corrected QT interval (QTcF)
≥ 450 msec;
・ Hemoglobin: < 8.0 g/dL;
・ Neutrophil count: < 1,000/mm3
;
・ Platelet count: < 50,000/mm3
;
・ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT):
> 3 times ULN defined at the investigational site; or
・ Creatinine: > 1.5 times ULN defined at the investigational site;
(2) Patients with a positive result for either hepatitis C virus antibody (HCV
antibody) or hepatitis B virus (HBV) surface antigen (HBs antigen) test
during the screening period. Alternatively, the patients with a negative result
for HBs antigen; however, with a positive result for either HBV surface
antibody (HBs antibody) or HBV core antibody (HBc antibody), and with an
HBV deoxyribonucleic acid (DNA) level (HBV-DNA level) ≥ the detection
sensitivity of the assay;
(3) Patients who are known to be positive for human immunodeficiency virus
antibody (HIV antibody) or human T-cell leukemia virus type I antibody
(HTLV-1 antibody);
(4) Patients who are known or suspected metastasis or invasion to the central
nervous system, or lymphoma lesions in the central nervous system;
(5) Patients who have a concurrent active malignancy other than PTCL with the
disease- or treatment-free period of < 5 years, excluding skin basal cell
carcinoma, skin squamous cell carcinoma and carcinoma in situ of the
cervix that are judged to have been cured;
(6) Patients who have concurrent or a past history of central nervous system
disease (e.g. seizure, dementia, Parkinson’s disease, Alzheimer’s disease),
cerebrovascular disorder (e.g. transient ischemic attack, cerebral infarction,
cerebral hemorrhage), or psychiatric disorder (e.g. schizophrenia,
depression, addiction);
(7) Patients who concurrently have any of the following conditions:
・ Congenital long QT syndrome;
・ Poorly controlled cardiac arrhythmia;
・ Poorly controlled diabetes mellitus;
・ Infections requiring systemic administration of antibiotic, antifungal or
antiviral drugs;
・ Acute hepatitis, chronic hepatitis, or liver cirrhosis; or
・ Serious acute or chronic organ dysfunction (e.g. cardiac, hepatic, renal,
or respiratory failure);
(8) Patients who have known or suspected hypersensitivity to arsenic;
(9) Patients who have used agents containing darinaparsin;
(10) Patients who have received anticancer chemotherapy (including continuous
use of oral administration or injection of corticosteroids equivalent to
> 10 mg/day of prednisolone, as anticancer therapy) or anticancer
immunotherapy (excluding antibody therapy) within 3 weeks before the day
of subject enrollment;
(11) Patients who have received antibody therapy (including investigational
drugs) within 12 weeks before the day of subject enrollment;
(12) Patients who have received radiotherapy within 3 weeks before the day of
subject enrollment;
(13) Patients who have received autologous hematopoietic stem cell transplant
within 12 weeks before the day of subject enrollment, or patients who have
received allogeneic hematopoietic stem cell transplant;
(14) Patients who underwent major surgery (e.g., surgery requiring systemic
anesthesia, craniotomy, thoracotomy, or laparotomy) within 4 weeks before
the day of subject enrollment;
(15) Patients who are participating in other clinical trials or received any
investigational drug or device within 4 weeks before the day of subject
enrollment;
(16) Patients who are unable to stay in the hospital for the period specified in the
protocol;
(17) Female patients who are breast-feeding, pregnancy or planned pregnancy;
(18) Patients of reproductive potential who will not be able to use adequate
contraceptive precautions during the treatment period and following
3 months after the last dosing of investigational drug; in the judgment of the
principal investigator or sub-investigator; or
(19) Patients with considerable concern for compliance with the protocol, in the
judgment of the principal investigator or sub-investigator.
(1) Patient with inadequately maintained major organ functions as evidenced by
the following laboratory test values taken at the screening visit. These
laboratory test values should not be affected by blood transfusion or
administration of hematopoietic growth factor agents, etc. Even though the
patients who meet none of the following criteria, subject’s condition should
not show an obvious tendency toward worsening as determined by the
principal investigator or sub-investigator:
・ Electrocardiogram (ECG): Fridericia-corrected QT interval (QTcF)
≥ 450 msec;
・ Hemoglobin: < 8.0 g/dL;
・ Neutrophil count: < 1,000/mm3
;
・ Platelet count: < 50,000/mm3
;
・ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT):
> 3 times ULN defined at the investigational site; or
・ Creatinine: > 1.5 times ULN defined at the investigational site;
(2) Patients with a positive result for either hepatitis C virus antibody (HCV
antibody) or hepatitis B virus (HBV) surface antigen (HBs antigen) test
during the screening period. Alternatively, the patients with a negative result
for HBs antigen; however, with a positive result for either HBV surface
antibody (HBs antibody) or HBV core antibody (HBc antibody), and with an
HBV deoxyribonucleic acid (DNA) level (HBV-DNA level) ≥ the detection
sensitivity of the assay;
(3) Patients who are known to be positive for human immunodeficiency virus
antibody (HIV antibody) or human T-cell leukemia virus type I antibody
(HTLV-1 antibody);
(4) Patients who are known or suspected metastasis or invasion to the central
nervous system, or lymphoma lesions in the central nervous system;
(5) Patients who have a concurrent active malignancy other than PTCL with the
disease- or treatment-free period of < 5 years, excluding skin basal cell
carcinoma, skin squamous cell carcinoma and carcinoma in situ of the
cervix that are judged to have been cured;
(6) Patients who have concurrent or a past history of central nervous system
disease (e.g. seizure, dementia, Parkinson’s disease, Alzheimer’s disease),
cerebrovascular disorder (e.g. transient ischemic attack, cerebral infarction,
cerebral hemorrhage), or psychiatric disorder (e.g. schizophrenia,
depression, addiction);
(7) Patients who concurrently have any of the following conditions:
・ Congenital long QT syndrome;
・ Poorly controlled cardiac arrhythmia;
・ Poorly controlled diabetes mellitus;
・ Infections requiring systemic administration of antibiotic, antifungal or
antiviral drugs;
・ Acute hepatitis, chronic hepatitis, or liver cirrhosis; or
・ Serious acute or chronic organ dysfunction (e.g. cardiac, hepatic, renal,
or respiratory failure);
(8) Patients who have known or suspected hypersensitivity to arsenic;
(9) Patients who have used agents containing darinaparsin;
(10) Patients who have received anticancer chemotherapy (including continuous
use of oral administration or injection of corticosteroids equivalent to
> 10 mg/day of prednisolone, as anticancer therapy) or anticancer
immunotherapy (excluding antibody therapy) within 3 weeks before the day
of subject enrollment;
(11) Patients who have received antibody therapy (including investigational
drugs) within 12 weeks before the day of subject enrollment;
(12) Patients who have received radiotherapy within 3 weeks before the day of
subject enrollment;
(13) Patients who have received autologous hematopoietic stem cell transplant
within 12 weeks before the day of subject enrollment, or patients who have
received allogeneic hematopoietic stem cell transplant;
(14) Patients who underwent major surgery (e.g., surgery requiring systemic
anesthesia, craniotomy, thoracotomy, or laparotomy) within 4 weeks before
the day of subject enrollment;
(15) Patients who are participating in other clinical trials or received any
investigational drug or device within 4 weeks before the day of subject
enrollment;
(16) Patients who are unable to stay in the hospital for the period specified in the
protocol;
(17) Female patients who are breast-feeding, pregnancy or planned pregnancy;
(18) Patients of reproductive potential who will not be able to use adequate
contraceptive precautions during the treatment period and following
3 months after the last dosing of investigational drug; in the judgment of the
principal investigator or sub-investigator; or
(19) Patients with considerable concern for compliance with the protocol, in the
judgment of the principal investigator or sub-investigator.
The Estimated Number of Participants
-
Taiwan
10 participants
-
Global
65 participants
