Peripheral T Cell LymphomaPhase 2NCT04470141
A Study of SHC014748M in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma
A Phase 2 study testing SHC014748M treatment in people with Peripheral T Cell Lymphoma, run by Nanjing Sanhome Pharmaceutical, Co., Ltd..
Trial summary
The purpose of this study is to evaluate the efficacy and safety of SHC014748M in patients with relapsed or refractory relapsed or refractory Peripheral T Cell Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- SHC014748M treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to Jul 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, male and female volunteers, above 18 years of age inclusive.
- Histologically or cytologically confirmed diagnosis of relapsed or refractory Peripheral T Cell Lymphoma,including but not limited to peripheral T-cell lymphoma-unspecified(PTCL-U),angioimmunoblastic T-cell lymphoma(AITL),ALK+/ALK-anaplastic large cell lymphoma(ALCL),subcutaneous panniculitis-like T-cell lymphoma(SPTL). Eligible patients have failed or progressed at least one standard treatment, have no standard treatment, or are intolerant for standard treatment at this stage as determined by the investigator.
- 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 as determined by investigators);ALT and AST≤2.5×ULN(ALT and AST≤5×ULN for subjects with impaired liver function caused by hepatic infiltration as determined by investigators);CLcr> 50 mL/min(according to Cockcroft-Gault).
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- 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.
- Volunteers 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.
Who cannot join
- Previous treatment with any PI3Kδ inhibitors.
- 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 the first dose of study drug.
- Evidence of central nervous system involvement of the malignancy,including invasion of brain parenchyma and meninges, or spinal cord compression.
- 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.
- Have moderate or severe cardiac disease, including but not limited to severe arrhythmias or abnormal cardiac conduction, such as ventricular arrhythmias requiring clinical intervention, degree II-III atrioventricular block,QTcF≥450 ms for male, QTcF≥470 ms for female, or other structural heart disease with high risk as determined by investigators;history of acute coronary syndrome, congestive heart failure,aortic dissection,stroke or other≥grade 3 cardiovascular and cerebrovascular events within 6 months prior to the first dose of study drug;New York Heart Association (NYHA) Class II or greater heart failure, or LVEF<55%;uncontrolled hypertension(systolic blood pressure>180 mmHg or diastolic blood pressure>100 mmHg with two measurements in a row);any risk factors to increase QTc or arrhythmias, including heart failure,hypokalemia,congenital long QTc syndrome,family history of long QT interval syndrome or history of unexplained sudden death occurred in first degree relative less than 40 years of age, or using any concomitant medication known to produce QTc prolongation.
- Evidence of active bacterial, fungal, or viral infection, and need systemic treatment with one week prior to the first dose of study drug.
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- Infection with hepatitis B virus(HBV) ( volunteers with HBsAg positive but HBV-DNA negative, or volunteers with HCV antibody positive but HCV-RNA negative can be enrolled), hepatitis C virus(HCV), syphilis,or human immunodeficiency virus (HIV).
- Have systematic hormonal therapy(prednisone>20mg/d or similar drugs with equivalent dose)or immunosuppressor therapy with 14 days prior to the first dose of study drug, except using topical,ocular,intra-articular,intranasal,inhaled corticosteroids,and preventive therapy using corticosteroids in short period(for instance,to prevent hypersensitivity to contrast media).
- Concomitant use of any strong inhibitors or inducers of CYP3A4(except drug withdrawal prior to the first dose of study drug).
- 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.
- Prior autologous hematopoietic stem cell transplantation within 2 months prior to the first dose of study drug.
- 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.
- Severe gastrointestinal disease affecting ingesting, transporting and absorbing of the study drug, include inability to swallow the drug,malabsorption syndrome,uncontrollable nausea and vomiting,history of extensive gastrointestinal resection,uncurable recurrent diarrhea,atrophic gastritis(age of onset<60),uncurable severe gastric diseases,crohn's disease,ulcerative colitis or complete Intestinal obstruction.
- Adverse events occurred during previous anticancer therapy have not been recovered to ≤1(CTCAE 5.0)except toxicity with no significant risk determined by investigators such as alopecia.
- History of hypersensitivity to the main composition or any inactive excipient of the study drug.
- Women who are breastfeeding.
- 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.
About this study
Official title: A Phase II, Multicenter Study to Investigate the Efficacy and Safety of SHC014748M in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma
The purpose of this study is to evaluate the efficacy and safety of SHC014748M in patients with relapsed or refractory relapsed or refractory Peripheral T Cell Lymphoma.
Read the 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 peripheral T cell lymphoma.
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- SHC014748M treatment
- Keywords
- PTCL, SHC014748M, Phosphatidylinositol 3-kinase (PI3K)
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHC014748M treatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| SHC014748M treatment | Experimental | SHC014748M capsule, 200mg QD, 28 days for each cycle Receives: Drug: SHC014748M treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: up to 12 months
Secondary outcomes (6)
Disease Control Rate(DCR)
Measured: up to 12 months
Progression-Free Survival(PFS)
Measured: up to 12 months
Time to Response(TTR)
Measured: up to 12 months
Duration of Response(DOR)
Measured: up to 12 months
Mean Change From Baseline in the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Scale.
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.
Measured: up to 12 months
Safety and Tolerability of SHC014748M Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study startAug 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470141
- Sponsor's protocol ID
- SHC014-II-02
- Status last verified
- Jul 2020
- First submitted
- 29 Jun 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter Study to Investigate the Efficacy and Safety of SHC014748M in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT04470141
- Acronym / sponsor ID
- SHC014-II-02
- Conditions
- Peripheral T Cell Lymphoma
- Keywords
- PTCL, SHC014748M, Phosphatidylinositol 3-kinase (PI3K)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of SHC014748M in patients with relapsed or refractory relapsed or refractory Peripheral T Cell 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 peripheral T cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHC014748M treatment | Experimental | Drug: SHC014748M treatmentSHC014748M capsule, 200mg QD, 28 days for each cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult, male and female volunteers, above 18 years of age inclusive.
- Histologically or cytologically confirmed diagnosis of relapsed or refractory Peripheral T Cell Lymphoma,including but not limited to peripheral T-cell lymphoma-unspecified(PTCL-U),angioimmunoblastic T-cell lymphoma(AITL),ALK+/ALK-anaplastic large cell lymphoma(ALCL),subcutaneous panniculitis-like T-cell lymphoma(SPTL). Eligible patients have failed or progressed at least one standard treatment, have no standard treatment, or are intolerant for standard treatment at this stage as determined by the investigator.
- 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.
Key exclusion criteria (18 listed)
- Previous treatment with any PI3Kδ inhibitors.
- 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 the first dose of study drug.
- Evidence of central nervous system involvement of the malignancy,including invasion of brain parenchyma and meninges, or spinal cord compression.
- 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.
- Have moderate or severe cardiac disease, including but not limited to severe arrhythmias or abnormal cardiac conduction, such as ventricular arrhythmias requiring clinical intervention, degree II-III atrioventricular block,QTcF≥450 ms for male, QTcF≥470 ms for female, or other structural heart disease with high risk as determined by investigators;history of acute coronary syndrome, congestive heart failure,aortic dissection,stroke or other≥grade 3 cardiovascular and cerebrovascular events within 6 months prior to the first dose of study drug;New York Heart Association (NYHA) Class II or greater heart failure, or LVEF<55%;uncontrolled hypertension(systolic blood pressure>180 mmHg or diastolic blood pressure>100 mmHg with two measurements in a row);any risk factors to increase QTc or arrhythmias, including heart failure,hypokalemia,congenital long QTc syndrome,family history of long QT interval syndrome or history of unexplained sudden death occurred in first degree relative less than 40 years of age, or using any concomitant medication known to produce QTc prolongation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHC014748M treatmentEach 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. | Drug | SHC014748M treatment |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 12 months
6 secondary outcomes
Disease Control Rate(DCR)
Time frame: up to 12 months
Progression-Free Survival(PFS)
Time frame: up to 12 months
Time to Response(TTR)
Time frame: up to 12 months
Duration of Response(DOR)
Time frame: 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHC014748M treatment in people with Peripheral T Cell Lymphoma, run by Nanjing Sanhome Pharmaceutical, Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.