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A Phase Ib Study of YY-20394 in Participants With B-cell Hematologic Malignancies

Primary Purpose

Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, Marginal Zone Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
YY-20394
Sponsored by
Shanghai YingLi Pharmaceutical Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Lymphocytic Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • histologically or cytologically confirmed relapse and/or refractory B cell hematologic malignancies(Excluding follicular lymphoma)
  • prior treatment with ≥1 prior standard anti-tumor regimens and 2 courses of treatments at least
  • eastern cooperative oncology group performance status of 0 to 2
  • life expectancy of at least 3 months
  • presence of >1.5cm radiographically measurable lymphadenopathy or extranodal lymphoid malignancy, and legibility in two vertical directions
  • acceptable organ functions
  • discontinuation of all other antitumor therapies before the first drug dose administration
  • for men and women of childbearing potential, willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up six periods
  • willingness and ability to provide written informed consent and to comply with the protocol requirements

Exclusion Criteria:

  • prior therapy with PI3K-delta inhibitors(except the intolerable subjects)
  • the dosage of steroid hormone(predisone equivalent) was greater than 20mg/d, and lasted for more than 14 days
  • medical condition of difficulty in swallowing, malabsorption, or other chronic gastrointestinal disease, or conditional that may hamper compliance and/or absorption of the investigational product
  • concurrent drugs which maybe prolong the QT during the study period
  • subjects with central nervous system metastasis
  • Prior or current medical condition of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc
  • active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
  • known history of chronic active hepatitis B infection, chronic active hepatitis C
  • known history of immunodeficiency, including HIV positive test, other acquired or congenital immunodeficiency disorders, organ transplantation or allogeneic bone marrow transplantation
  • autologous hematopoietic stem cell transplantation was received within 90 days before the first dose administration
  • prior or ongoing heart disease, including: angina pectoris, clinically significant arrhythmia, myocardial infarction, heart failure, and any other heart disease judged by the researchers not eligible to the study
  • pregnancy or breastfeeding
  • prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant or impair the assessment of study results
  • receiving granulocyte colony-stimulating factor(GCSF) or blood transfusion within seven days before screening
  • history of a non-lymphoma malignancy except for adequately treated local basal cell carcinoma of the skin and cervical carcinoma in situ
  • subjects, in the opinion of the the Investigator, who are unsuitable to participate in the study for any other reason.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    YY-20394

    Arm Description

    treatment with YY-20394 will be continued until tumor progression or development of unacceptable toxicity.

    Outcomes

    Primary Outcome Measures

    Adverse events evaluated by NCI CTCAE V5.0
    incidence of adverse events and associated dose of YY-20394
    Overall response rate
    the percentage of participants achieving a complete response or partial response
    disease control rate
    the percentage of participants achieving a complete response or partial response or stable disease

    Secondary Outcome Measures

    Full Information

    First Posted
    February 19, 2020
    Last Updated
    February 19, 2020
    Sponsor
    Shanghai YingLi Pharmaceutical Co. Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04279405
    Brief Title
    A Phase Ib Study of YY-20394 in Participants With B-cell Hematologic Malignancies
    Official Title
    A Phase 1b Study to Assess the Safety and Efficacy of YY-20394 in Subjects With Recurrent and/or Refractory B-cell Hematologic Malignancies
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2020 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai YingLi Pharmaceutical Co. Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Protocol YY-20394-007 is a phase1 open-label, single-arm, multi-centre study to assess the safety and efficacy of YY-20394 in participants with relapse and/or refractory B cell malignant hematological tumor. eligible participants will initiate oral therapy with YY-20394 at a starting dose of 80mg taken once per day. treatment with YY-20394 can continue in compliant participants as long as the study is still ongoing and the participants appear to benefiting from treatment with acceptable safety.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, Marginal Zone Lymphoma, Mantle Cell Lymphoma, Diffuse Large B Cell Lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    YY-20394
    Arm Type
    Experimental
    Arm Description
    treatment with YY-20394 will be continued until tumor progression or development of unacceptable toxicity.
    Intervention Type
    Drug
    Intervention Name(s)
    YY-20394
    Intervention Description
    YY-20394 80mg tablet administered orally once daily
    Primary Outcome Measure Information:
    Title
    Adverse events evaluated by NCI CTCAE V5.0
    Description
    incidence of adverse events and associated dose of YY-20394
    Time Frame
    Throughout the study for approximately 2 years
    Title
    Overall response rate
    Description
    the percentage of participants achieving a complete response or partial response
    Time Frame
    Throughout the study for approximately 2 years
    Title
    disease control rate
    Description
    the percentage of participants achieving a complete response or partial response or stable disease
    Time Frame
    Throughout the study for approximately 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: histologically or cytologically confirmed relapse and/or refractory B cell hematologic malignancies(Excluding follicular lymphoma) prior treatment with ≥1 prior standard anti-tumor regimens and 2 courses of treatments at least eastern cooperative oncology group performance status of 0 to 2 life expectancy of at least 3 months presence of >1.5cm radiographically measurable lymphadenopathy or extranodal lymphoid malignancy, and legibility in two vertical directions acceptable organ functions discontinuation of all other antitumor therapies before the first drug dose administration for men and women of childbearing potential, willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up six periods willingness and ability to provide written informed consent and to comply with the protocol requirements Exclusion Criteria: prior therapy with PI3K-delta inhibitors(except the intolerable subjects) the dosage of steroid hormone(predisone equivalent) was greater than 20mg/d, and lasted for more than 14 days medical condition of difficulty in swallowing, malabsorption, or other chronic gastrointestinal disease, or conditional that may hamper compliance and/or absorption of the investigational product concurrent drugs which maybe prolong the QT during the study period subjects with central nervous system metastasis Prior or current medical condition of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy known history of chronic active hepatitis B infection, chronic active hepatitis C known history of immunodeficiency, including HIV positive test, other acquired or congenital immunodeficiency disorders, organ transplantation or allogeneic bone marrow transplantation autologous hematopoietic stem cell transplantation was received within 90 days before the first dose administration prior or ongoing heart disease, including: angina pectoris, clinically significant arrhythmia, myocardial infarction, heart failure, and any other heart disease judged by the researchers not eligible to the study pregnancy or breastfeeding prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant or impair the assessment of study results receiving granulocyte colony-stimulating factor(GCSF) or blood transfusion within seven days before screening history of a non-lymphoma malignancy except for adequately treated local basal cell carcinoma of the skin and cervical carcinoma in situ subjects, in the opinion of the the Investigator, who are unsuitable to participate in the study for any other reason.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hanying Bao, MD,PhD
    Phone
    86 21-51370693
    Email
    hybao@yl-pharma.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yang Shu, MMed
    Phone
    86 21-58328851
    Ext
    8117
    Email
    yshu@yl-pharma.com

    12. IPD Sharing Statement

    Learn more about this trial

    A Phase Ib Study of YY-20394 in Participants With B-cell Hematologic Malignancies

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