- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04431089
Efficacy and Safety of SHC014748M in Patients With Relapsed or Refractory Follicular (FL) or Marginal Zone (MZL) Lymphoma
January 27, 2021 updated by: Nanjing Sanhome Pharmaceutical, Co., Ltd.
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
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.
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
122
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hongchan Zhang
- Phone Number: 15150516871
- Email: zhanghcyf@sanhome.com
Study Contact Backup
- Name: Chao Wang
- Phone Number: 13851803148
- Email: wangchao@sanhome.com
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210029
- Recruiting
- The First Affiliated Hospital with Nanjing Medical University
-
Contact:
- Jianyong Li, MD
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Recruiting
- The First Affiliated Hospital, Zhejiang University
-
Contact:
- Jie Jin, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
- Prior autologous hematopoietic stem cell transplantation within 3 months prior to screening.
- History of immune deficiency(acquired and congenital), or history of organ transplantation, or allogeneic bone marrow or hematopoietic stem cell transplantation; with active autoimmune disease or history of autoimmune disease including Interstitial pneumonia, autoimmune enteritis, autoimmune hepatitis and systemic lupus erythematosus
- History of any uncured malignant tumor in the past five years except for the following: clinically cured cervical or breast carcinoma in situ, local basal cell or squamous cell carcinoma of the skin, thyroid tumor.
- Inability to swallow the drug, or history of diseases affecting gastrointestinal functions significantly including malabsorption syndrome,bariatric surgery,inflammatory bowel disease, partial or complete intestinal obstruction.
- Adverse events occurred during previous anticancer therapy have not been recovered to ≤1(CTCAE 5.0).
- History of hypersensitivity to the main composition or any inactive excipient of the study drug.
- Women who are breastfeeding.
- With alcohol or drug abuse disorder.
- History of stroke or intracranial hemorrhage with 6 months prior to screening.
- Attenuated live vaccination within 4 weeks prior to screening.
- With basic medical condition leading to risk of taking study drugs judged by investigators, or with confusion to toxicity and adverse events.
- Judgment by the investigator that the patient should not participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SHC014748M treatment
SHC014748M capsule, 200mg QD, 28 days for each cycle
|
Each treatment cycle is comprised of 28-day consecutive dosing of SHC014748M, 200mg QD (Days 1 to28).
Upon completion of each cycle, patients may continue to receive oral SHC014748M if they can benefit from the treatment and the toxicity is tolerable.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: up to 12 months
|
Proportion of patients who have either a complete or partial response before any treatment change.
|
up to 12 months
|
Lymph Node Response (LNR)
Time Frame: up to 12 months
|
LNR was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the product of the perpendicular diameters (SPD) of measurable index lesions.
|
up to 12 months
|
Time to Response (TTR)
Time Frame: up to 12 months
|
TTR was defined as the interval from the start of SHC014748M treatment to the first documentation of complete response(CR) or partial response(PR).
|
up to 12 months
|
Progression-Free Survival (PFS)
Time Frame: up to 12 months
|
PFS was defined as the interval from the start of SHC014748M treatment to the earlier of the first documentation of disease progression or death from any cause.
PFS was analyzed using Kaplan-Meier (KM) estimates.
|
up to 12 months
|
Duration of Response (DOR)
Time Frame: up to 12 months
|
DOR was defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression as or death from any cause.
DOR was analyzed using KM estimates.
|
up to 12 months
|
Mean Change From Baseline in the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Scale.
Time Frame: up to 12 months
|
The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on health related quality of life(HRQL) and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects.
It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7).
The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess non-Hodgkins lymphoma(NHL) related symptoms and concerns.
All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4).
Higher scores are associated with a better quality of life.
|
up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and Tolerability of SHC014748M Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms.
Time Frame: up to 12 months
|
up to 12 months
|
Pharmacokinetics Parameter: Cmax
Time Frame: 4 weeks
|
4 weeks
|
Pharmacokinetics Parameter: Tmax
Time Frame: 4 weeks
|
4 weeks
|
Pharmacokinetics Parameter: ACUlast
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jianyong Li, MD, The First Affiliated Hospital with Nanjing Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 9, 2020
Primary Completion (Anticipated)
April 1, 2021
Study Completion (Anticipated)
July 1, 2021
Study Registration Dates
First Submitted
June 1, 2020
First Submitted That Met QC Criteria
June 10, 2020
First Posted (Actual)
June 16, 2020
Study Record Updates
Last Update Posted (Actual)
January 28, 2021
Last Update Submitted That Met QC Criteria
January 27, 2021
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHC014-II-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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