Peripheral T Cell LymphomaPhase 2NCT04061772
A Study of Bortezomib Combined With CHEP in Peripheral T Cell Lymphoma
A Phase 2 study testing Bortezomib, Etoposide and Cyclophosphamide in people with Peripheral T Cell Lymphoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of bortezomib combined with CHEP regimen in peripheral T cell lymphoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- Bortezomib, Etoposide and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2019to 5 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) volunteer to participate in the clinical study: fully understand and know the study, and sign the informed consent in person;Willing to follow and able to complete all test procedures.
- 2) age: 18~75 years old (including), male or female. 3) peripheral T cell lymphoma confirmed by histopathology: including peripheral T non-specific type, ALK positive interstitial enlarged cell lymphoma, ALK negative interstitial enlarged cell lymphoma, vascular immune maternal lymphoma, and enteropathy T lymphoma.
- 4) no previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor therapy.
- 5) the ECOG score is 0-2. 6) there must be at least one evaluable or measurable lesion meeting Lugano 2014 criteria (evaluable lesions: PET/CT examination showed increased uptake of lymph nodes or external nodes (higher than liver) and PET/CT and/or CT characteristics consistent with lymphoma manifestations; Measurable lesions: long diameter >15mm in nodular lesions or long diameter >10mm in external nodules, accompanied by increased FDG uptake).The absence of measurable lesions and increased diffuse FDG uptake in the liver should be excluded.
- 7) adequate organ and bone marrow function, no serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney function or immune deficiency (no blood transfusion, granulocyte colony stimulating factor or other relevant medical support was received within 14 days before the use of the study drugs) : A) blood routine: absolute count of neutrophils (ANC) ≥1.5 for 109/L (1500/mm3), platelet ≥75 for 109/L, hemoglobin ≥10 g/dL (for bone marrow involvement, platelet ≥50 for 109/L, ANC ≥1.0 for 109/L, hemoglobin ≥8 g/dL).
- liver function: serum bilirubin ≤1.5 times the upper limit of normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤1.5 times the upper limit of normal value (AST allowed if liver is involved, ALT≤5 times the upper limit of normal value).
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- renal function: the upper limit of serum creatinine ≤1.5 times normal value. D) coagulation function: INR≤1.5 times the upper limit of normal value;PT and APTT≤1.5 upper limit of normal (unless subject is receiving anticoagulant therapy and PT and APTT are within the expected range of anticoagulant therapy at time of screening).
- 8) in cardiac function examination, left ventricular ejection fraction (LVEF) ≥ 50%.
- 9) the serum pregnancy test was negative, and effective contraceptive measures were taken from the signing of informed consent until 6 months after the last chemotherapy.
Who cannot join
- 1) NK/T lymphoma or aggressive natural killer cell leukemia. 2) with hemophagocytic syndrome. 3) primary central nervous system lymphoma or secondary central nervous system involvement.
- 4) participating in other clinical studies or the first study drug administration is less than 4 weeks from the end of treatment in the previous clinical study.
- 5) other malignancies in the past 5 years, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast and carcinoma in situ of the cervix, which have been treated with radical therapy.
- 6) previous anti-tumor therapy, including chemotherapy, immunotherapy, radiotherapy, and biological therapy (tumor vaccines, cytokines, or growth factors that control cancer).
- 7) major surgery was performed within 28 days before the study began. 8) a patient with a known history of Human Immunodeficiency Virus infection and/or acquired Immunodeficiency syndrome.
- 9) patients with active chronic hepatitis b or active hepatitis c.Screening stage of hepatitis b surface antigen or hepatitis c virus antibody positive patients, must further by hepatitis b virus DNA (no more than 1000 iu/ml) and HCV RNA detection (shall not exceed the method detection limit), in the activity of the ruled out the need for treatment after hepatitis b or hepatitis c infection, before the experiment.Hepatitis b carriers, hepatitis b patients who are stable after drug treatment and hepatitis c patients who have been cured can be enrolled.
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- 10) active tuberculosis. 11) any active infections, including but not limited to bacterial, fungal or viral infections, that require systematic anti-infective therapy within 14 days prior to the initiation of the study.
- 12) pregnant or lactating women. 13) patients with uncontrolled concomitant diseases, including but not limited to symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, active peptic ulcer or hemorrhagic diseases.
- 14) having a history of mental illness;Having no capacity or limited capacity. 15) the underlying condition of the patient may increase the risk of receiving the study drug, or may cause confusion as to the toxicity and its judgment.
- 16) patients considered unsuitable to participate in this study by other researchers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Haiyan Yang, PhD, 0086-571-88122192, yanghy@zjcc.org.cn
Cong Li, MD, 0086-571-88122192, licong@zjcc.org.cn
About this study
Official title: A Prospective Study of Bortezomib Combined With CHEP Regimen in the Treatment of Primary Peripheral T Cell Lymphoma
To evaluate the efficacy and safety of bortezomib combined with CHEP regimen in peripheral T cell lymphoma
Read the detailed description
The purpose of this study was to evaluate the efficacy and safety of bortezomib combined with CHEP in patients with peripheral T cell lymphoma. Primary end point of this study were objective response rate including complete remission rate and partial remission rate.
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- Bortezomib, Etoposide, Cyclophosphamide, Pharmorubicin, Prednisone
- Keywords
- Bortezomib, CHEP
- 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.
BortezomibDrug
Bortezomib injection
EtoposideDrug
Etoposide injection
CyclophosphamideDrug
Cyclophosphamide injection
PharmorubicinDrug
Pharmorubicin injection
PrednisoneDrug
Prednisone tablet
| Study group | Role | What they receive |
|---|---|---|
| BCHEP | Experimental | Bortezomib：1.3mg/m2, intravenous drip, d1,d8, every 3 weeks； Etoposide：100mg/m2,intravenous drip, d1-3, every 3 weeks； Cyclophosphamide：750mg/m2,intravenous drip, d1, every 3 weeks； Pharmorubicin：75mg/m2,intravenous drip, d1,every 3 weeks； Prednisone：100mg,tablet by mouth, d1-5, every 3 weeks. Receives: Drug: Bortezomib; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Pharmorubicin; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
overall response rate including complete response and partial response
Measured: up to 18 weeks
Secondary outcomes (3)
adverse effects
adverse effects and serious adverse effects
Measured: through study completion, an average of 30 days
survival outcome
Progression Free Survival
Measured: through study completion, at least 1 year
survival outcome
overall survival
Measured: through study completion, at least 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start12 Aug 2019 (estimated)
- Primary completion5 Jul 2021 (estimated)
- Study completion5 Dec 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.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Chen, PhD, Study director, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061772
- Sponsor's protocol ID
- IRB-2019-96
- Status last verified
- Aug 2019
- First submitted
- 11 Aug 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The parimary and secondary end point of the study, the characteristics of patients are to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Bortezomib Combined With CHEP Regimen in the Treatment of Primary Peripheral T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT04061772
- Acronym / sponsor ID
- IRB-2019-96
- Conditions
- Peripheral T Cell Lymphoma
- Keywords
- Bortezomib, CHEP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 12 Aug 2019 (estimated)
- Primary completion
- 5 Jul 2021 (estimated)
- Study completion
- 5 Dec 2021 (estimated)
- First posted
- 20 Aug 2019 (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.
To evaluate the efficacy and safety of bortezomib combined with CHEP regimen in peripheral T cell lymphoma
Detailed description
The purpose of this study was to evaluate the efficacy and safety of bortezomib combined with CHEP in patients with peripheral T cell lymphoma. Primary end point of this study were objective response rate including complete remission rate and partial remission rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCHEP | Experimental | Drug: Bortezomib, Drug: Etoposide, Drug: Cyclophosphamide, Drug: Pharmorubicin, Drug: PrednisoneBortezomib：1.3mg/m2, intravenous drip, d1,d8, every 3 weeks； Etoposide：100mg/m2,intravenous drip, d1-3, every 3 weeks； Cyclophosphamide：750mg/m2,intravenous drip, d1, every 3 weeks； Pharmorubicin：75mg/m2,intravenous drip, d1,every 3 weeks； Prednisone：100mg,tablet by mouth, d1-5, every 3 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1) volunteer to participate in the clinical study: fully understand and know the study, and sign the informed consent in person;Willing to follow and able to complete all test procedures.
- 2) age: 18~75 years old (including), male or female. 3) peripheral T cell lymphoma confirmed by histopathology: including peripheral T non-specific type, ALK positive interstitial enlarged cell lymphoma, ALK negative interstitial enlarged cell lymphoma, vascular immune maternal lymphoma, and enteropathy T lymphoma.
- 4) no previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor therapy.
- 5) the ECOG score is 0-2. 6) there must be at least one evaluable or measurable lesion meeting Lugano 2014 criteria (evaluable lesions: PET/CT examination showed increased uptake of lymph nodes or external nodes (higher than liver) and PET/CT and/or CT characteristics consistent with lymphoma manifestations; Measurable lesions: long diameter >15mm in nodular lesions or long diameter >10mm in external nodules, accompanied by increased FDG uptake).The absence of measurable lesions and increased diffuse FDG uptake in the liver should be excluded.
- 7) adequate organ and bone marrow function, no serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney function or immune deficiency (no blood transfusion, granulocyte colony stimulating factor or other relevant medical support was received within 14 days before the use of the study drugs) : A) blood routine: absolute count of neutrophils (ANC) ≥1.5 for 109/L (1500/mm3), platelet ≥75 for 109/L, hemoglobin ≥10 g/dL (for bone marrow involvement, platelet ≥50 for 109/L, ANC ≥1.0 for 109/L, hemoglobin ≥8 g/dL).
Key exclusion criteria (10 listed)
- 1) NK/T lymphoma or aggressive natural killer cell leukemia. 2) with hemophagocytic syndrome. 3) primary central nervous system lymphoma or secondary central nervous system involvement.
- 4) participating in other clinical studies or the first study drug administration is less than 4 weeks from the end of treatment in the previous clinical study.
- 5) other malignancies in the past 5 years, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast and carcinoma in situ of the cervix, which have been treated with radical therapy.
- 6) previous anti-tumor therapy, including chemotherapy, immunotherapy, radiotherapy, and biological therapy (tumor vaccines, cytokines, or growth factors that control cancer).
- 7) major surgery was performed within 28 days before the study began. 8) a patient with a known history of Human Immunodeficiency Virus infection and/or acquired Immunodeficiency syndrome.
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 |
|---|---|---|
| BortezomibBortezomib injection | Drug | BCHEP |
| EtoposideEtoposide injection | Drug | BCHEP |
| CyclophosphamideCyclophosphamide injection | Drug | BCHEP |
| PharmorubicinPharmorubicin injection | Drug | BCHEP |
| PrednisonePrednisone tablet | Drug | BCHEP |
Primary outcome
response rate
Time frame: up to 18 weeks
overall response rate including complete response and partial response
3 secondary outcomes
adverse effects
Time frame: through study completion, an average of 30 days
survival outcome
Time frame: through study completion, at least 1 year
survival outcome
Time frame: through study completion, at least 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Individual participant dataSharing planned: Yes. The parimary and secondary end point of the study, the characteristics of patients are to be shared.
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Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
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Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma
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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.
Ming Chen, PhD study director
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bortezomib, Etoposide and Cyclophosphamide in people with Peripheral T Cell Lymphoma, run by Zhejiang Cancer Hospital at 1 site in China.
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 10 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 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Cong Li, MD (+8615267115611, licong@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: up to 18 weeks). 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 20 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.