YY-20394 、GEMOX Treatment Diffuse Large B-cell Lymphoma Single Arm, Open, Multicentrized Phase 1b/2 Clinical Trial

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

YY-20394 Combined With GEMOX in the Treatment of Patients With Relapsed and/or Refractory Diffuse Large B-cell Lymphoma With a Single Arm, Open, Multicentrized Phase 1b/2 Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04500561
• Other study ID #: YY-20394-008
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: August 20, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: July 2020
• Source: Shanghai YingLi Pharmaceutical Co. Ltd.
• Contact: Hanying Bao, PHD
• Phone: 86 21-5137069
• Email: hybao[@]yl-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a one-arm, open, multicenter phase 1b/2 clinical trial of YY-20394 combined with GEMOX second-line or above in patients with relapsed and/or refractory diffuse large B-cell lymphoma.

YY-20394 combined with GEMOX was used as a cycle for 21 days. The dose of YY-20394 was 80mg/ day as recommended in phase 2, and the dose of GEMOX was treated according to clinical standards.

Description:

This study is a one-arm, open, multicenter phase 1b/2 clinical trial of YY-20394 combined with GEMOX second-line or above in patients with relapsed and/or refractory diffuse large B-cell lymphoma.

YY-20394 combined with GEMOX was used as a cycle for 21 days. The dose of YY-20394 was 80mg/ day as recommended in phase 2, and the dose of GEMOX was treated according to clinical standards.

The first six subjects of group to evaluate the safety of YY - 20394 joint GEMOX, if the joint treatment of 6 cases of subjects before, If YY-20394 and/or chemotherapy related 4 degrees of hematology toxicity or level 3 non hematologic toxicity were appearanced less than 2 cases, continued to dose of 80 mg/day, if more than 2 cases, YY-20394 doses dropped to 60 mg/day.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: December 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with recurrent and/or refractory diffuse large B-cell lymphoma confirmed histologically or cytologically; Progress after first-line or above systemic treatment (at least CD20 monoclonal antibody treatment); ECOG Performance Status (PS) grade 0 ~ 1; Expected survival =3 months; The patient has at least one measurable lesion conforming to the IWG2007 standard; Good organ function level:ANC=1.0×109/L;PLT=70×109/L;Hb=80 g/L

;TBIL=1.5×ULN; ALT?AST=2.5×ULN;BUN/Urea?Cr=1.5×ULN;LVEF=50%; The Fridericia method corrected the QT interval (QTcF) for males < 450 ms and females < 470 ms.

From the end of any previous anti-tumor therapy (including radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy) to the washout period of this study =4 weeks; Did not participate in the clinical trial as a subject within 1 month before the trial; According to the researcher's judgment, it can comply with the experimental protocol; Volunteer to participate in this clinical trial, understand the study procedures and be able to sign the informed consent in person.

Exclusion Criteria:

• Those who have used PI3K as the target of anti-tumor drug progression (except those who cannot tolerate out of the group); Any other anti-tumor therapy within 4 weeks; The presence of a third interstitial effusion that cannot be controlled by drainage or other methods (such as massive pleural and ascites); Use of steroid hormone dosage (equivalent amount of prednisone) greater than 20mg/ day within 4 weeks, and continuous use for more than 14 days; Unable to swallow, chronic diarrhea and intestinal obstruction, existing multiple factors affecting drug intake and absorption; Unable to suspend medications that may prolong QT interval during the study (e.g., antiarrhythmic agents); Having lympoma with central nervous system (CNS) invasion; Allergic constitution, or known anaphylaxis to any component of this product; Having active viral, bacterial or fungal infection requiring treatment (e.g., pneumonia); Uncontrolled diabetes, pulmonary fibrosis, acute pulmonary disease, interstitial lung disease, or liver failure; Patients with HBV, HCV infection (defined as HbsAg and/or HbcAb positive and HBV DNA copy number =1×104 copy number /ml or =2000 IU/ml) or acute or chronic active hepatitis C; Medical history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency disease, or history of organ transplantation or allogeneic bone marrow transplantation; Having received autologous hematopoietic stem cell transplantation within 90 days prior to the first dose in this study; Any cardiac disease, including (1) angina pectoris; (2) arrhythmia requiring drug therapy or of clinical significance; (3) myocardial infarction; (4) heart failure; (5) any other cardiac disease that is judged by investigators as not suitable to participate in this trial; Pregnant or lactating women or baseline pregnancy testing positive for fertile women; Concomitant diseases (such as serious hypertension, diabetes mellitus, thyroid disease) seriously hazardous to patient's safety or completion of study as judged by the investigator; Having other primary malignancy in recent 5 years;

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• YY-20394
Yy-20394 combined with Gemcitabine and Oxaliplatin was used as a cycle for 21 days. The dose of YY-20394 was 80mg/ day as recommended in phase 2, and the dose of Gemcitabine and Oxaliplatin was treated according to clinical standards.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai YingLi Pharmaceutical Co. Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective remission rate	Response will be determined by the revised International Working Group (IWG 2007) efficacy evaluation criteria	with in 42 days after the first dos
Secondary	disease control rate	Response will be determined by the revised International Working Group (IWG 2007) efficacy evaluation criteria	with in 42 days after the first dos
Secondary	Progression Free Survival	Response will be determined by the revised International Working Group (IWG 2007) efficacy evaluation criteria	with in 42 days after the first dos
Secondary	drug safety	Adverse events evaluated by NCI CTCAE v5.0	one and half a year