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Efficacy and Safety of SHC014748M in Patients With Relapsed or Refractory Follicular (FL) or Marginal Zone (MZL) Lymphoma | Clinical Trials | Clareo Health

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Efficacy and Safety of SHC014748M in Patients With Relapsed or Refractory Follicular (FL) or Marginal Zone (MZL) Lymphoma

A Phase II Multicenter Study to Investigate the Efficacy and Safety of SHC014748M in Patients With Relapsed or Refractory Follicular (FL) or Marginal Zone (MZL) Lymphoma

NCT04431089•Nanjing Sanhome Pharmaceutical, Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of SHC014748M in patients with relapsed or refractory relapsed or refractory follicular (FL) or marginal one (MZL) lymphoma.

Detailed Description

This is a phase II, multicenter study to assess the efficacy and safety of SHC014748M, an oral inhibitor of PI3K delta, in patients with relapsed or refractory relapsed or refractory follicular (FL) or marginal one (MZL) lymphoma.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult, male and female volunteers, above 18 years of age inclusive.
•Histologically or cytologically confirmed diagnosis of relapsed or refractory FL(grade 1, 2 or 3a) and MZL, including splenic marginal zone lymphoma(SMZL), nodal marginal zone B cell lymphoma(NMZL) and mucosa associated lymphoid tissue(MALT) lymphoma. Relapse refers to disease progression after adequate treatment to remission；refractory refers to no remission after adequate treatment. The above "remission" includes complete remission and partial remission. Adequate treatment refers to two or more treatments with CD20 monoclonal antibody (CDE approved for marketing) combined with alkylation agent, including but not limited to bendamustine, cyclophosphamide, ifosfamide, chlorambucil, melphalan, busulfan and nitrosoureas.
•Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
•Life expectancy ≥ 3 months.
•Patients have at least 1 measurable lesion that measures ≥1.5 cm in a single dimension as assessed by CT or MRI.
•Adequate organ function, as defined by the following values:ANC≥1.0×10\^9/L； PLT≥50×10\^9/L;Hb≥80 g/L;TBIL≤2×ULN(TBIL\>2×ULN for subjects with Gilbert syndrome,TBIL\>3×ULN for subjects with focal compression of bile duct judged by investigators); ALT and AST≤2.5×ULN(ALT and AST≤5×ULN for subjects with impaired liver function caused by hepatic infiltration);blood urea nitrogen(BUN) and Cr≤1.5×ULN;LVEF≥50%;QTcF \<450 ms for male, QTcF \<470 ms for female.
•Men and women of childbearing potential are willing to employ an effective method of contraception for the entire duration of study and 6 months after the last dose, and female subjects of childbearing potential have a negative pregnancy test at baseline.
•Subjects did not participate in other clinical trials within 1 month prior to study entry.
•Provision of signed and dated, written informed consent prior to any study-specific evaluation.

Exclusion Criteria

•Previous treatment with any PI3Kδ inhibitors.
•Evidence of aggressive lymphoma(suspected clinical transformation should be conformed by biopsy).
•Had any other anti-tumor treatment within 4 weeks prior to screening(including radiotherapy, chemotherapy, Chinese herbal anti-tumor treatment and major surgery); targeted therapy with 5 half-life period prior to screening.
•Evidence of central nervous system involvement of the malignancy.
•Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, uncontrolled pleural effusion and ascites, uncontrolled diabetes, severe or debilitating lung disease.
•Any of the severe heart diseases, including New York Heart Association (NYHA) Class II or greater heart failure, arrhythmias requiring medical treatment, and history of myocardial infarction or unstable angina within 6 months prior to screening.Requiring any concomitant medication known to prolong the QT interval within 5 half-life period.
•Evidence of active bacterial, fungal, or viral infection, and need systemic treatment.
•Active infection with hepatitis B virus (HBV) (HBsAg positive, or HBsAg negative and HBV-DNA positive), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
•Concomitant use of any strong inhibitors or inducers of CYP3A4(except drug withdrawal prior to first dose of investigational drug.
•Use of granulocyte colony-stimulating factor(G-CSF) or blood transfusion within 7 days before the hematology test at screening.
+12 more criteria

Locations (2)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Key Dates

Start Date

May 9, 2020

Primary Completion Date

April 1, 2021

Completion Date

July 1, 2021

Last Updated

January 28, 2021

Enrollment

122

ESTIMATED participants

Conditions

Follicular Lymphoma(FL)Marginal Zone Lymphoma(MZL)

Interventions

SHC014748M

DRUG

Contacts

Chao Wang

CONTACT

13851803148 wangchao@sanhome.com

Hongchan Zhang

CONTACT

15150516871 zhanghcyf@sanhome.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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