Newly Diagnosed Peripheral T-cell LymphomaNCT05896813
CMOP Regimen and Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma
A study testing CMOP+Chidamide in people with Newly Diagnosed Peripheral T-cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Peripheral T-cell lymphoma (PTCL) is a highly heterogeneous and aggressive non-Hodgkin's lymphoma. The incidence rate of PTCL in China is much higher than the global average, and there is no unified standard treatment for initial PTCL. Currently, the CHOP regimen is widely used as first-line treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Newly Diagnosed Peripheral T-cell Lymphoma
- What is being tested?
- CMOP+Chidamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Jan 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient understands the content of this study, voluntarily participates in the study, and signs the informed consent form (ICF);
- Age: 18-80 years;
- Expected survival time ≥ 3 months;
- Histologically confirmed PTCL, one of the following subtypes:
- PTCL not otherwise specified (PTCL-NOS)
- Nodal T follicular helper (Tfh) cell lymphoma
Show all 11Show fewer
- Other subtypes of PTCL that the researcher deems eligible for inclusion in the study;
- At least one measurable or evaluable lesion that meets the Lugano2014 criteria: for lymph node lesions, the longest diameter should be >1.5 cm, and for extranodal lesions, the longest diameter should be >1.0 cm;
- ECOG score 0-2 points;
- Bone marrow function: neutrophil count ≥ 1.5×109/L, platelet count ≥ 75×109/L, hemoglobin ≥ 80 g/L (for patients with bone marrow involvement, the neutrophil count can be relaxed to ≥ 1.0×109/L, platelet count can be relaxed to ≥ 50×109/L, hemoglobin can be relaxed to ≥ 75 g/L);
- Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal, AST and ALT ≤ 2.5 times the upper limit of normal (≤ 5 times the upper limit of normal for patients with liver involvement), and total bilirubin ≤ 1.5 times the upper limit of normal (≤ 3 times the upper limit of normal for patients with liver involvement).
Who cannot join
- 1. Hypersensitivity to any study drug or its components; 2. Uncontrollable systemic diseases (such as advanced infection, uncontrolled hypertension, diabetes, etc.); 3. One of the following applies to cardiac function and disease:
- Long QT syndrome or QTc interval >480 ms;
- Complete left bundle branch block, II or III degree atrioventricular block;
- Severe, uncontrolled arrhythmia requiring medication;
- New York Heart Association (NYHA) grade ≥ III;
- Left ventricular ejection fraction (LVEF) <50%;
- A history of acute myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or other arrhythmias or clinically significant pericardial disease requiring treatment within the six months prior to recruitment or evidence of acute ischemic or active conduction system abnormalities on the electrocardiogram; 4. Active hepatitis B or C infection (hepatitis B surface antigen positive and hepatitis B virus DNA > 1x104 copies/mL; hepatitis C virus RNA > 1x104 copies/mL); 5. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 6. Previously or currently diagnosed with other malignant tumors (except for non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have not been treated and effectively controlled within the past five years); 7. Central nervous system (CNS) lymphoma or a history of CNS lymphoma; 8. Pregnant or lactating women and childbearing patients who do not want to take contraceptive measures; 9. Other situations judged by the researcher to be unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hematological Department, People's Hospital of Jiangsu Province
Nanjing, Jiangsu, 210029
Wei Xu, PhD, +86-2568302182, xuwei10000@hotmail.com
About this study
Official title: A Prospective, Single-arm, Multicenter Clinical Study of the Combination of CMOP Regimen and Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma
Peripheral T-cell lymphoma (PTCL) is a highly heterogeneous and aggressive non-Hodgkin's lymphoma. The incidence rate of PTCL in China is much higher than the global average, and there is no unified standard treatment for initial PTCL. Currently, the CHOP regimen is widely used as first-line treatment. However, the overall response rate is still low, and effective therapies need to be explored. Epigenetics and genetics jointly determine critical features of tumors, and exploring new treatment strategies and developing targeted drugs based on deep understanding of the pathogenesis is of significant importance. The combined application of DNMT inhibitors and HDAC inhibitors has strong scientific support. The Phase II clinical study of Mitoxantrone Hydrochloride Liposome in treating relapsed or refractory PTCL achieved positive results and regulatory approval. The CMOP regimen combining Mitoxantrone Hydrochloride Liposome with Chidamide is worth exploring for initial PTCL treatment.
Read the detailed description
Peripheral T-cell lymphoma (PTCL) originates from mature thymic T-cells and is a highly heterogeneous and aggressive non-Hodgkin's lymphoma (NHL). The 2016 revised WHO classification divides PTCL into 4 major categories with over 30 subtypes, including common subtypes such as anaplastic large-cell lymphoma (ALCL), ALK-positive/+ and ALK-negative/-, angioimmunoblastic T-cell lymphoma (AITL), and PTCL, not otherwise specified (PTCL-NOS) . In 2020, the estimated global incidence of new NHL patients was over 540,000, with over 90,000 cases in China. Compared with B-cell lymphomas, PTCL has a lower incidence rate, but PTCL patients' proportion in China is significantly higher than in Western countries at approximately 21% . The incidence rate of PTCL in China accounts for nearly 21% of NHL, much higher than the global average .
Currently, there is no unified standard treatment for initial PTCL. The National Comprehensive Cancer Network (NCCN) guidelines in the US and the Chinese Society of Clinical Oncology (CSCO) recommend using the CHOP regimen (cyclophosphamide, doxorubicin, vincristine, and prednisone) as first-line treatment . However, the CHOP regimen is mainly based on treatment experience with B-cell lymphomas, and more effective therapies need to be explored. Over the past few decades, research progress in both basic and clinical aspects of PTCL has been slow, with poor treatment outcomes. The overall response rate of first-line treatment is 50%-70%. Except for ALCL, ALK(+), PTCL patients receiving induction therapy are suggested to undergo autologous hematopoietic stem cell transplantation (ASCT) treatment, yet even so, the overall response rate is still low, with a poor prognosis. Except for ALCL, ALK+ patients, the five-year overall survival (OS) rate of other subtypes is less than 50% , and PTCL patients are prone to relapse , with a three-year OS probability of about 20% .
The overall treatment effect for PTCL patients is still not ideal, and their prognosis has not improved over the past few decades. Patients often relapse early, with a shorter progression-free survival (PFS) and OS. Genetic mutations, variations, and tumor occurrence and development are closely related, and the same is true for epigenetic regulation. Epigenetics and genetics jointly determine critical features of a tumor: heterogeneity, plasticity, stem cell-like properties, and immune escape. As lymphomas often have epigenetic mutations, exploring new treatment strategies and developing targeted drugs based on a deep understanding of the pathogenesis is of significant importance in improving the efficacy of PTCL treatment.
Since both highly methylated DNA and low acetylated histones can lead to a closed chromatin state by independent mechanisms, resulting in the silencing of tumor suppressor genes , the combined application of DNMT inhibitors and HDAC inhibitors has strong scientific support. Both DNMT inhibitors and HDAC inhibitors have a chemosensitizing effect. Acetylation changes the chromatin structure, plays a role in regulating epigenetics as well as in chemotherapy sensitization, while DNMT inhibitors can enhance the sensitivity of lymphoma resistant to chemotherapy. Currently, the combination of AZA+HDACi in epigenetic treatments has been explored for lymphoma treatment.
In the Phase II clinical study of Mitoxantrone Hydrochloride Liposome, 108 patients with relapsed or refractory PTCL were treated with Mitoxantrone Hydrochloride Liposome alone, achieving an objective response rate (ORR) of 41.7% (32.3%, 51.5%) and a complete response rate (CRR) of 23.1% (25/108). The median PFS was 8.5 months, and the median OS was 22.8 months. The treatment was well-tolerated and efficacious, resulting in regulatory approval for Mitoxantrone Hydrochloride Liposome in treating relapsed or refractory PTCL adult patients . Based on this, the CMOP regimen, which is based on Mitoxantrone Hydrochloride Liposome combined with Chidamide, is worth exploring for initial PTCL treatment.
- Being tested
- CMOP+Chidamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMOP+ChidamideDrug
Cyclophosphamide: 750 mg/m2, d1; Mitoxantrone Hydrochloride Liposome: 20 mg/m2, d1; Vincristine: 1.4 g/m2, d1 (maximum dose of 2 mg), or vindesine 3 mg/m2, d1; Prednisone: 60 mg/m2, d1-d5; Chidamide:20 mg, biw. The treatment is administered every 3 weeks as a cycle and lasts for a total of 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| CMOP+Chi | Experimental | Cyclophosphamide: 750 mg/m2, d1; Mitoxantrone Hydrochloride Liposome: 20 mg/m2, d1; Vincristine: 1.4 g/m2, d1 (maximum dose of 2 mg), or vindesine 3 mg/m2, d1; Prednisone: 60 mg/m2, d1-d5; Chidamide:20 mg, biw. The treatment is administered every 3 weeks as a cycle and lasts for a total of 6 cycles. Receives: Drug: CMOP+Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
overall response rate
Measured: 1 year
Secondary outcomes (4)
CRR
Complete remission rate
Measured: 1 year
2-year PFS
2-year progression-free survival
Measured: 2 years
2-year OS
2-year overall survival
Measured: 2 years
SAE
The frequency of serious adverse events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Mar 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896813
- Sponsor's protocol ID
- CSPC-DED-PTCL-K
- Status last verified
- May 2023
- First submitted
- 1 Jun 2023
- Last updated
- 9 Jun 2023
- 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 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multicenter Clinical Study of the Combination of CMOP Regimen and Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05896813
- Acronym / sponsor ID
- CSPC-DED-PTCL-K
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 9 Jun 2023 (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.
Peripheral T-cell lymphoma (PTCL) is a highly heterogeneous and aggressive non-Hodgkin's lymphoma. The incidence rate of PTCL in China is much higher than the global average, and there is no unified standard treatment for initial PTCL. Currently, the CHOP regimen is widely used as first-line treatment. However, the overall response rate is still low, and effective therapies need to be explored. Epigenetics and genetics jointly determine critical features of tumors, and exploring new treatment strategies and developing targeted drugs based on deep understanding of the pathogenesis is of significant importance. The combined application of DNMT inhibitors and HDAC inhibitors has strong scientific support. The Phase II clinical study of Mitoxantrone Hydrochloride Liposome in treating relapsed or refractory PTCL achieved positive results and regulatory approval. The CMOP regimen combining Mitoxantrone Hydrochloride Liposome with Chidamide is worth exploring for initial PTCL treatment.
Detailed description
Peripheral T-cell lymphoma (PTCL) originates from mature thymic T-cells and is a highly heterogeneous and aggressive non-Hodgkin's lymphoma (NHL). The 2016 revised WHO classification divides PTCL into 4 major categories with over 30 subtypes, including common subtypes such as anaplastic large-cell lymphoma (ALCL), ALK-positive/+ and ALK-negative/-, angioimmunoblastic T-cell lymphoma (AITL), and PTCL, not otherwise specified (PTCL-NOS) . In 2020, the estimated global incidence of new NHL patients was over 540,000, with over 90,000 cases in China. Compared with B-cell lymphomas, PTCL has a lower incidence rate, but PTCL patients' proportion in China is significantly higher than in Western countries at approximately 21% . The incidence rate of PTCL in China accounts for nearly 21% of NHL, much higher than the global average .
Currently, there is no unified standard treatment for initial PTCL. The National Comprehensive Cancer Network (NCCN) guidelines in the US and the Chinese Society of Clinical Oncology (CSCO) recommend using the CHOP regimen (cyclophosphamide, doxorubicin, vincristine, and prednisone) as first-line treatment . However, the CHOP regimen is mainly based on treatment experience with B-cell lymphomas, and more effective therapies need to be explored. Over the past few decades, research progress in both basic and clinical aspects of PTCL has been slow, with poor treatment outcomes. The overall response rate of first-line treatment is 50%-70%. Except for ALCL, ALK(+), PTCL patients receiving induction therapy are suggested to undergo autologous hematopoietic stem cell transplantation (ASCT) treatment, yet even so, the overall response rate is still low, with a poor prognosis. Except for ALCL, ALK+ patients, the five-year overall survival (OS) rate of other subtypes is less than 50% , and PTCL patients are prone to relapse , with a three-year OS probability of about 20% .
The overall treatment effect for PTCL patients is still not ideal, and their prognosis has not improved over the past few decades. Patients often relapse early, with a shorter progression-free survival (PFS) and OS. Genetic mutations, variations, and tumor occurrence and development are closely related, and the same is true for epigenetic regulation. Epigenetics and genetics jointly determine critical features of a tumor: heterogeneity, plasticity, stem cell-like properties, and immune escape. As lymphomas often have epigenetic mutations, exploring new treatment strategies and developing targeted drugs based on a deep understanding of the pathogenesis is of significant importance in improving the efficacy of PTCL treatment.
Since both highly methylated DNA and low acetylated histones can lead to a closed chromatin state by independent mechanisms, resulting in the silencing of tumor suppressor genes , the combined application of DNMT inhibitors and HDAC inhibitors has strong scientific support. Both DNMT inhibitors and HDAC inhibitors have a chemosensitizing effect. Acetylation changes the chromatin structure, plays a role in regulating epigenetics as well as in chemotherapy sensitization, while DNMT inhibitors can enhance the sensitivity of lymphoma resistant to chemotherapy. Currently, the combination of AZA+HDACi in epigenetic treatments has been explored for lymphoma treatment.
In the Phase II clinical study of Mitoxantrone Hydrochloride Liposome, 108 patients with relapsed or refractory PTCL were treated with Mitoxantrone Hydrochloride Liposome alone, achieving an objective response rate (ORR) of 41.7% (32.3%, 51.5%) and a complete response rate (CRR) of 23.1% (25/108). The median PFS was 8.5 months, and the median OS was 22.8 months. The treatment was well-tolerated and efficacious, resulting in regulatory approval for Mitoxantrone Hydrochloride Liposome in treating relapsed or refractory PTCL adult patients . Based on this, the CMOP regimen, which is based on Mitoxantrone Hydrochloride Liposome combined with Chidamide, is worth exploring for initial PTCL treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMOP+Chi | Experimental | Drug: CMOP+ChidamideCyclophosphamide: 750 mg/m2, d1; Mitoxantrone Hydrochloride Liposome: 20 mg/m2, d1; Vincristine: 1.4 g/m2, d1 (maximum dose of 2 mg), or vindesine 3 mg/m2, d1; Prednisone: 60 mg/m2, d1-d5; Chidamide:20 mg, biw. The treatment is administered every 3 weeks as a cycle and lasts for a total of 6 cycles. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The patient understands the content of this study, voluntarily participates in the study, and signs the informed consent form (ICF);
- Age: 18-80 years;
- Expected survival time ≥ 3 months;
- Histologically confirmed PTCL, one of the following subtypes:
- At least one measurable or evaluable lesion that meets the Lugano2014 criteria: for lymph node lesions, the longest diameter should be >1.5 cm, and for extranodal lesions, the longest diameter should be >1.0 cm;
Key exclusion criteria (7 listed)
- 1. Hypersensitivity to any study drug or its components; 2. Uncontrollable systemic diseases (such as advanced infection, uncontrolled hypertension, diabetes, etc.); 3. One of the following applies to cardiac function and disease:
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 |
|---|---|---|
| CMOP+ChidamideCyclophosphamide: 750 mg/m2, d1; Mitoxantrone Hydrochloride Liposome: 20 mg/m2, d1; Vincristine: 1.4 g/m2, d1 (maximum dose of 2 mg), or vindesine 3 mg/m2, d1; Prednisone: 60 mg/m2, d1-d5; Chidamide:20 mg, biw. The treatment is administered every 3 weeks as a cycle and lasts for a total of 6 cycles. | Drug | CMOP+Chi |
Primary outcome
ORR
Time frame: 1 year
overall response rate
4 secondary outcomes
CRR
Time frame: 1 year
2-year PFS
Time frame: 2 years
2-year OS
Time frame: 2 years
SAE
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMOP+Chidamide in people with Newly Diagnosed Peripheral T-cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University 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 11 inclusion and 7 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 9 Jun 2023. 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.
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 Jinhua Liang (15952032421, 1151525490@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 1 year). 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 9 Jun 2023.