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NCT02653976 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2024-01-26

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Tumor Response (Central Assessment)

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outcome · POSTED

Tumor Response (Local Assessment)

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outcome · POSTED

Progression-Free Survival

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outcome · POSTED

Overall Survival

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outcome · POSTED

Number of Participants With Adverse Events (AEs)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
20 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: SP-02L (darinaparsin for injection)
    label
    SP-02L (darinaparsin for injection)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. SP-02L (darinaparsin for injection)
    description
    Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
    name
    SP-02L (darinaparsin for injection)
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
67
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    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.
secondary Outcomes
  1. description
    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.
    measure
    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.
  2. description
    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.
    measure
    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.
  3. description
    Overall Survival was the duration of time from the first day of study drug administration to the date of death from any cause.
    measure
    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.
  4. description
    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).
    measure
    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.
Full 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.
Source references
references
  1. citation
    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.
    pmid
    36661315
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        exact text
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        start
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      offset unit
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      query cond
      Peripheral T-Cell Non-Hodgkin Lymphoma
      query disease state id
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      source file
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      source file sha256
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      source json pointer
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      source record id
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      source string sha256
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    Preserved source evidence · Not medical advice