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A Study of YY-20394 in Participants With Relapsed/Refractory Follicular Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma, Follicular

Status
Unknown status
Phase
Phase 2
Locations
China
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 Lymphoma, Follicular

Eligibility Criteria

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

Inclusion Criteria:

  1. Patient is ≥18 years of age at the time of signing the informed consent.
  2. Has histologically or cytologically confirmed follicular non-Hodgkin's lymphoma
  3. Has received at least two prior lines of systemic therapy (excluding radiation) for follicular lymphoma.(Has been treated with CD20 mAb and at least one alkylating agent, including but not limited to bendamostine, cyclophosphamide, isocyclophosphamide, chlorophenyl butylamine, Malan, busulfan, nitroso
  4. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  5. Has a life expectancy >3 months.
  6. Has radiographically measurable disease as per IRWG Criteria with at least one nodal lesion.
  7. Fine organ function ANC≥1.0×109/L; PLT≥70×109/L(≥50×109/L in patients with bone marrow infiltration ); Hb≥80 g/L(≥70 g/L in patients with bone marrow infiltration); TBIL≤1.5×ULN; Both ALT and AST≤2.5×ULN; Both BUN/Urea andCr≤1.5×ULN; LVEF≥50%; QTcF(QT interval corrected by friderica)Male<450 ms、Female<470 ms。
  8. The washout period lasted at least four weeks of previous anti-tumor treatment (including radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted treatment) taken by the patient before the study to ensure complete clearance from the body.
  9. Has adequate organ function as defined in Table 5 1. Specimen for this assessment must be collected within 14 days prior to the first dose of study treatment:
  10. According to the judgment of the researchers, the patients can comply with the trial plan
  11. The patient did not participate in the clinical trial as a subject within 1 month before the trial;

Exclusion Criteria:

  • 1) Disease progress in the use of PI3kδ inhibitors 2) Pathological transformation of follicular non-Hodgkin's lymphoma to diffuse large B cell lymphoma 3) Any anti-tumor treatment within 4weeks. 4) Pathological fluid accumulations(such as hydrothorax and ascites )can not be controlled by drainage and other method in the third space 5) The dosage of steroid hormone (prednisone equivalent) was more than 20mg / day, and it was used continuously for more than 14 days 6) Has inability to swallow\ chronic diarrhea\ intestine obstruction snd other reasons that could have effluence on the administration and absorbtion. of the drug 7) Can't discontinue use of drugs (such as antiarrhythmic drugs) that may cause QT prolongation during the study.

    8) Lymphoma Patients with involvement of central nerve system. 9) Allergic constitution or known allergic history to the components of the drug.

    10) Has active effection of viruses\bacterium\ fungi and need to be treated(such as pneumonia ).

    11) Uncontrolled diabetes, pulmonary fibrosis, acute lung disease, interstitial lung disease, or liver failure 12) Has infection of HBV or HCV(Definition: HbsAg and/or HbcAb positive and the copy number of HBV DNA≥1×104/ml or ≥2000 IU/ml ) HCV antibody positive(acute or chornic effected actively) 13) Has history of immunodeficiency disease,include HIV positive or other acquired \ congenital immunodeficiency disease or history of allogeneic bone marrow organ transplangtation or history of hematopoietic stem cell transplangtation 14) Has received hematopoietic stem cell transplangtation within 90 days before the first dose of study treatment.

    15) Has any cardiac disease,including:(1)angina;(2) arrhythmias need to be clinical intervented;(3)myocardial infarction;(4)heart failure;(5)any other cardiac diseases that is not suitable for this trail according to the judgement of recheachers.

    16) Pregnant and lactating women or fertile women who have a positive pregnancy test 17) Has accompany diseases which do harm to the safety of patients or have impact on the study(such as server hypertension\diabetes\thyroid diseases ) 18) Has other kinds of malignant tumors except skin basal cell carcinoma and cervical carcinoma in situ

Sites / Locations

  • Hematology Hospital of Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

YY-20394

Arm Description

YY-20394 tablets will be given daily for 28 days in 28-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons.

Outcomes

Primary Outcome Measures

Overall response rate, ORR
Overall response rate (ORRProportion of patients whose tumor volume reduces to a predetermined value and can maintain the minimum time limit-) assessed by an Independent Review Committee (IRC).

Secondary Outcome Measures

Overall response rate (ORR)
Overall response rate (ORR-Proportion of patients whose tumor volume reduces to a predetermined value and can maintain the minimum time limit) assessed by reseachers.
Progression free survival, PFS
PFS, defined as the time from the first dose of study treatment to first documented disease progression or death due to any cause, whichever occurs first.
Overall survival, OS
The time from randomization to death for any reason.
Disease control rate, DCR
The percentage of cases with remission (PR+CR)and stable lesions(SD) after treatment in the number of evaluable cases.

Full Information

First Posted
April 28, 2020
Last Updated
May 7, 2020
Sponsor
Shanghai YingLi Pharmaceutical Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04370405
Brief Title
A Study of YY-20394 in Participants With Relapsed/Refractory Follicular Non-Hodgkin's Lymphoma
Official Title
A Phase 2, Single Arm, Open Label Clinical Study to Assess the Safety and Efficacy of YY-20394 in Subjects With Relapsed/Refractory Follicular Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
February 22, 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
Yes

5. Study Description

Brief Summary
This is a study designed to evaluate the efficacy and safety of oral YY-20394 in patients with R/R follicular non-Hodgkin's lymphoma who have failed at least two prior systemic therapies.
Detailed Description
The study will be conducted in China to provide safety and efficacy data from this region. A Safety Run-in will be conducted to confirm the safety of the recommended Phase 2 dose (RP2D), 80 mg once daily, in a Asian population. PK samplings at Cycle 1, Day 1 will be taken.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Follicular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
123 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
YY-20394
Arm Type
Experimental
Arm Description
YY-20394 tablets will be given daily for 28 days in 28-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons.
Intervention Type
Drug
Intervention Name(s)
YY-20394
Intervention Description
YY-20394 tablets will be given daily for 28 days in 28-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons.
Primary Outcome Measure Information:
Title
Overall response rate, ORR
Description
Overall response rate (ORRProportion of patients whose tumor volume reduces to a predetermined value and can maintain the minimum time limit-) assessed by an Independent Review Committee (IRC).
Time Frame
Throughout the study for approximately 2 years
Secondary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
Overall response rate (ORR-Proportion of patients whose tumor volume reduces to a predetermined value and can maintain the minimum time limit) assessed by reseachers.
Time Frame
Throughout the study for approximately 2 years
Title
Progression free survival, PFS
Description
PFS, defined as the time from the first dose of study treatment to first documented disease progression or death due to any cause, whichever occurs first.
Time Frame
Throughout the study for approximately 2 years
Title
Overall survival, OS
Description
The time from randomization to death for any reason.
Time Frame
Throughout the study for approximately 2 years
Title
Disease control rate, DCR
Description
The percentage of cases with remission (PR+CR)and stable lesions(SD) after treatment in the number of evaluable cases.
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: Patient is ≥18 years of age at the time of signing the informed consent. Has histologically or cytologically confirmed follicular non-Hodgkin's lymphoma Has received at least two prior lines of systemic therapy (excluding radiation) for follicular lymphoma.(Has been treated with CD20 mAb and at least one alkylating agent, including but not limited to bendamostine, cyclophosphamide, isocyclophosphamide, chlorophenyl butylamine, Malan, busulfan, nitroso Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Has a life expectancy >3 months. Has radiographically measurable disease as per IRWG Criteria with at least one nodal lesion. Fine organ function ANC≥1.0×109/L; PLT≥70×109/L(≥50×109/L in patients with bone marrow infiltration ); Hb≥80 g/L(≥70 g/L in patients with bone marrow infiltration); TBIL≤1.5×ULN; Both ALT and AST≤2.5×ULN; Both BUN/Urea andCr≤1.5×ULN; LVEF≥50%; QTcF(QT interval corrected by friderica)Male<450 ms、Female<470 ms。 The washout period lasted at least four weeks of previous anti-tumor treatment (including radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted treatment) taken by the patient before the study to ensure complete clearance from the body. Has adequate organ function as defined in Table 5 1. Specimen for this assessment must be collected within 14 days prior to the first dose of study treatment: According to the judgment of the researchers, the patients can comply with the trial plan The patient did not participate in the clinical trial as a subject within 1 month before the trial; Exclusion Criteria: 1) Disease progress in the use of PI3kδ inhibitors 2) Pathological transformation of follicular non-Hodgkin's lymphoma to diffuse large B cell lymphoma 3) Any anti-tumor treatment within 4weeks. 4) Pathological fluid accumulations(such as hydrothorax and ascites )can not be controlled by drainage and other method in the third space 5) The dosage of steroid hormone (prednisone equivalent) was more than 20mg / day, and it was used continuously for more than 14 days 6) Has inability to swallow\ chronic diarrhea\ intestine obstruction snd other reasons that could have effluence on the administration and absorbtion. of the drug 7) Can't discontinue use of drugs (such as antiarrhythmic drugs) that may cause QT prolongation during the study. 8) Lymphoma Patients with involvement of central nerve system. 9) Allergic constitution or known allergic history to the components of the drug. 10) Has active effection of viruses\bacterium\ fungi and need to be treated(such as pneumonia ). 11) Uncontrolled diabetes, pulmonary fibrosis, acute lung disease, interstitial lung disease, or liver failure 12) Has infection of HBV or HCV(Definition: HbsAg and/or HbcAb positive and the copy number of HBV DNA≥1×104/ml or ≥2000 IU/ml ) HCV antibody positive(acute or chornic effected actively) 13) Has history of immunodeficiency disease,include HIV positive or other acquired \ congenital immunodeficiency disease or history of allogeneic bone marrow organ transplangtation or history of hematopoietic stem cell transplangtation 14) Has received hematopoietic stem cell transplangtation within 90 days before the first dose of study treatment. 15) Has any cardiac disease,including:(1)angina;(2) arrhythmias need to be clinical intervented;(3)myocardial infarction;(4)heart failure;(5)any other cardiac diseases that is not suitable for this trail according to the judgement of recheachers. 16) Pregnant and lactating women or fertile women who have a positive pregnancy test 17) Has accompany diseases which do harm to the safety of patients or have impact on the study(such as server hypertension\diabetes\thyroid diseases ) 18) Has other kinds of malignant tumors except skin basal cell carcinoma and cervical carcinoma in situ
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanying Bao, MD,PhD
Phone
86 21-51370693
Email
hybao@yl-pharm.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoming Zhang, PhD
Phone
86 21-51370693
Email
xmzhang@shangpharma.com
Facility Information:
Facility Name
Hematology Hospital of Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
3000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lugui Qiu, MD,PhD
Phone
022-23909083
Email
qiulg@ihcams.ac.cn

12. IPD Sharing Statement

Learn more about this trial

A Study of YY-20394 in Participants With Relapsed/Refractory Follicular Non-Hodgkin's Lymphoma

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