T Cell LymphomaNCT05772728
Chidamide Combined With Azacitidine and Mitoxantrone Liposome in the Treatment of Relapsed/Refractory (nTFHL)
A study testing Cidapenem combined with azacitidine and mitoxantrone liposome (CAM) regimen in people with T Cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
Intranodal follicular adjuvant T-cell lymphoma (nTFHL) is a type of peripheral T-cell lymphoma (PTCL) that is a new subtype in WHO 2022, which includes 3 categories corresponding to previous angioimmunoblast T-cell lymphoma (AITL), follicular T-cell lymphoma, and PTCL with TFH phenotype, named nTFHL-angioblast type … Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- T Cell Lymphoma
- What is being tested?
- Cidapenem combined with azacitidine and mitoxantrone liposome (CAM) regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Dec 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- R/R nTFHL confirmed by pathological tissue, with diagnostic criteria referring to the 2022 WHO diagnostic criteria.
- Patients who have undergone at least one previous systemic treatment (including chemotherapy, HSCT, etc.) without remission or relapse after remission.
- Signed written informed consent and who are able to comply with the visits and related procedures specified in the protocol.
- whole-body PET/CT performed 28 days prior to study entry, which must have at least 1 evaluable or measurable lesion meeting Lugano 2014 criteria: lymph node lesions, measurable lymph nodes need to be >1.5 cm in length; non-lymphoid lesions, measurable extra-nodal lesions need to be >1.0 cm in length.
- with a PS score of 0 to 2 according to ECOG
- with adequate organ and bone marrow function, defined as follows: neutrophil count ≥ 1.5×109/L, platelet count ≥ 75×109/L, and hemoglobin ≥ 80 g/L (relaxed to ≥ 1.0×109/L for neutrophil count, ≥ 50×109/L for platelet count, and ≥ 75 g/L for hemoglobin in patients with bone marrow involvement);
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- Liver and kidney function: serum creatinine (Cr) ≤ 1.5 times the upper limit of normal value; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal value (≤ 5 times the upper limit of normal value for patients with liver invasion); total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (≤ 3 times the upper limit of normal value for patients with liver invasion);
- life expectancy of more than 3 months
- age 18 to 75 years.
Who cannot join
- Subjects with a history of prior antitumor therapy that is one of the following.
- Previous recipients of mitoxantrone or mitoxantrone liposomes.
- Prior treatment with doxorubicin or other anthracyclines with a total cumulative dose of doxorubicin > 360 mg/m2 (other anthracyclines converted to 1 mg doxorubicin equivalent to 2 mg epirubicin).
- Patients who have received autologous hematopoietic stem cell transplantation (ASCT) within 100 days of the first dose, or who have received allogeneic hematopoietic stem cell transplantation.
- have received antitumor therapy (including chemotherapy, targeted therapy, hormonal therapy, administration of herbal medicine with antitumor activity, etc.) or participated in other clinical trials and received clinical trial medication within 4 weeks prior to the first administration of this study drug.
- Hypersensitivity reaction to any investigational drug or its components.
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- Uncontrollable systemic disease (e.g., progressive infection, uncontrollable hypertension, diabetes mellitus, etc.).
- Cardiac function and disease consistent with one of the following.
- Long QTc syndrome or QTc interval >480 ms.
- Complete left bundle branch block, second or third degree atrioventricular block.
- Severe, uncontrolled arrhythmias requiring drug therapy.
- American New York Heart Association classification ≥ Class III.
- Cardiac ejection fraction (LVEF) less than 50%.
- History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or any other arrhythmia requiring treatment, history of clinically severe pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities within 6 months prior to recruitment.
- Active hepatitis B and C infection (positive hepatitis B virus surface antigen and hepatitis B virus DNA greater than 1 x 103 copies/mL; hepatitis C virus RNA greater than 1 x 103 copies/mL).
- Human immunodeficiency virus (HIV) infection (HIV antibody positive).
- previous or current concurrent other malignancies (in addition to effectively controlled non-melanoma basal cell carcinoma of the skin, breast/cervical carcinoma in situ and other malignancies that have not been treated and also effectively controlled within the last five years)
- Primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment.
- Pregnant and lactating women and patients of childbearing age who do not wish to use contraception
- Persons with mental disorders/unable to obtain informed consent.
- Those who are judged by the investigator to be unsuitable for participation in this trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Single-arm, Open Clinical Efficacy Observational Study of Cidapenem Combined With Azacitidine and Mitoxantrone Liposome (CAM) Regimen for Relapsed/Refractory Intra-nodal Follicular Adjuvant T-cell Lymphoma (nTFHL)
Intranodal follicular adjuvant T-cell lymphoma (nTFHL) is a type of peripheral T-cell lymphoma (PTCL) that is a new subtype in WHO 2022, which includes 3 categories corresponding to previous angioimmunoblast T-cell lymphoma (AITL), follicular T-cell lymphoma, and PTCL with TFH phenotype, named nTFHL-angioblast type ( nTFHL-AI), nTFHL-follicular (nTFHL-F), and nTFHL-non-specific (nTFH-NOS), respectively.1 nTFHL-AI has a relatively high incidence in PTCL, accounting for about 25-30% of cases, with an aggressive clinical presentation, often with multisystem involvement and with immune system abnormalities. nTFHL shares common immunophenotypic features, namely TFH cell phenotype: CD279/PD1, CD10, BCL6, CXCL13, ICOS, SAP, and CCR5, and at least 2 of the stated immune markers combined with CD4 positivity are required for the diagnosis of nTFHL.1, TFH cell and nTFHL cell also share similar reproducible genetic abnormalities, such as RHOA G17V, DNMT3A, IDH2, TET2, often involving epigenetic genetic abnormalities 2, especially abnormalities of DNMT3A, IDH2, and TET2 are more frequent in myeloid disorders.
Basic studies have shown that cidabenamide and anthracyclines have synergistic effects to promote apoptosis in PTCL cells; and the adverse events of the two do not completely overlap, suggesting that a mitoxantrone liposome-based regimen combined with cidabenamide for PTCL may have a better clinical benefit.
Based on the above findings, the investigators propose to further investigate the efficacy and safety of cidapenem combined with azacitidine and mitoxantrone liposome (CAM) regimen, i.e., cidapenem combined with azacitidine dual epigenetic modulation on the basis of mitoxantrone liposome, in the treatment of patients with R/R nTFHL using a randomized, prospective, multicenter phase II clinical trial, which is expected to further improve ORR, PFS and OS.
Read the detailed description
Induction treatment period. Cetapenem 20 mg orally twice a week Azacitidine 75 mg/m2 subcutaneously d1-7 Mitoxantrone liposomes 20 mg/m2 intravenous d6
1 treatment cycle every 21 days. Maintenance treatment period: cidabendiamide 20 mg orally twice weekly/28 days Cycle
- Conditions
- T Cell Lymphoma
- Being tested
- Cidapenem combined with azacitidine and mitoxantrone liposome (CAM) regimen
- Medical subject headings
- Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cidapenem combined with azacitidine and mitoxantrone liposome (CAM) regimenDrug
Also called CAM
CAM regimen (every 21 days as a treatment cycle). Cetapenem 20 mg orally twice weekly Azacitidine 75 mg/m2 subcutaneously d1-7 Mitoxantrone liposomes 20 mg/m2 intravenous d6
| Study group | Role | What they receive |
|---|---|---|
| CAG Group | Experimental | Cidapenem combined with azacitidine and mitoxantrone liposomes Receives: Drug: Cidapenem combined with azacitidine and mitoxantrone liposome (CAM) regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate
Measured: 6 months
Secondary outcomes (3)
2 year PFS rate
2 year PFS rate
Measured: 2 years
2 year OS rate
2 year OS rate
Measured: 2 years
DOR
Duration of remission
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 posted16 Mar 2023
- Study startApr 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 23 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WEI XU, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772728
- Sponsor's protocol ID
- 2022-SR-571
- Status last verified
- Mar 2023
- First submitted
- 29 Dec 2022
- Last updated
- 16 Mar 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 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm, Open Clinical Efficacy Observational Study of Cidapenem Combined With Azacitidine and Mitoxantrone Liposome (CAM) Regimen for Relapsed/Refractory Intra-nodal Follicular Adjuvant T-cell Lymphoma (nTFHL)
- ClinicalTrials.gov ID
- NCT05772728
- Acronym / sponsor ID
- 2022-SR-571
- Conditions
- T Cell Lymphoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Mar 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.
Intranodal follicular adjuvant T-cell lymphoma (nTFHL) is a type of peripheral T-cell lymphoma (PTCL) that is a new subtype in WHO 2022, which includes 3 categories corresponding to previous angioimmunoblast T-cell lymphoma (AITL), follicular T-cell lymphoma, and PTCL with TFH phenotype, named nTFHL-angioblast type ( nTFHL-AI), nTFHL-follicular (nTFHL-F), and nTFHL-non-specific (nTFH-NOS), respectively.1 nTFHL-AI has a relatively high incidence in PTCL, accounting for about 25-30% of cases, with an aggressive clinical presentation, often with multisystem involvement and with immune system abnormalities. nTFHL shares common immunophenotypic features, namely TFH cell phenotype: CD279/PD1, CD10, BCL6, CXCL13, ICOS, SAP, and CCR5, and at least 2 of the stated immune markers combined with CD4 positivity are required for the diagnosis of nTFHL.1, TFH cell and nTFHL cell also share similar reproducible genetic abnormalities, such as RHOA G17V, DNMT3A, IDH2, TET2, often involving epigenetic genetic abnormalities 2, especially abnormalities of DNMT3A, IDH2, and TET2 are more frequent in myeloid disorders.
Basic studies have shown that cidabenamide and anthracyclines have synergistic effects to promote apoptosis in PTCL cells; and the adverse events of the two do not completely overlap, suggesting that a mitoxantrone liposome-based regimen combined with cidabenamide for PTCL may have a better clinical benefit.
Based on the above findings, the investigators propose to further investigate the efficacy and safety of cidapenem combined with azacitidine and mitoxantrone liposome (CAM) regimen, i.e., cidapenem combined with azacitidine dual epigenetic modulation on the basis of mitoxantrone liposome, in the treatment of patients with R/R nTFHL using a randomized, prospective, multicenter phase II clinical trial, which is expected to further improve ORR, PFS and OS.
Detailed description
Induction treatment period. Cetapenem 20 mg orally twice a week Azacitidine 75 mg/m2 subcutaneously d1-7 Mitoxantrone liposomes 20 mg/m2 intravenous d6
1 treatment cycle every 21 days. Maintenance treatment period: cidabendiamide 20 mg orally twice weekly/28 days Cycle
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAG Group | Experimental | Drug: Cidapenem combined with azacitidine and mitoxantrone liposome (CAM) regimenCidapenem combined with azacitidine and mitoxantrone liposomes |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- R/R nTFHL confirmed by pathological tissue, with diagnostic criteria referring to the 2022 WHO diagnostic criteria.
- Patients who have undergone at least one previous systemic treatment (including chemotherapy, HSCT, etc.) without remission or relapse after remission.
- Signed written informed consent and who are able to comply with the visits and related procedures specified in the protocol.
- whole-body PET/CT performed 28 days prior to study entry, which must have at least 1 evaluable or measurable lesion meeting Lugano 2014 criteria: lymph node lesions, measurable lymph nodes need to be >1.5 cm in length; non-lymphoid lesions, measurable extra-nodal lesions need to be >1.0 cm in length.
- with a PS score of 0 to 2 according to ECOG
Key exclusion criteria (21 listed)
- Subjects with a history of prior antitumor therapy that is one of the following.
- Hypersensitivity reaction to any investigational drug or its components.
- Uncontrollable systemic disease (e.g., progressive infection, uncontrollable hypertension, diabetes mellitus, etc.).
- Cardiac function and disease consistent with one of the following.
- Active hepatitis B and C infection (positive hepatitis B virus surface antigen and hepatitis B virus DNA greater than 1 x 103 copies/mL; hepatitis C virus RNA greater than 1 x 103 copies/mL).
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 |
|---|---|---|
| Cidapenem combined with azacitidine and mitoxantrone liposome (CAM) regimenAlso: CAMCAM regimen (every 21 days as a treatment cycle). Cetapenem 20 mg orally twice weekly Azacitidine 75 mg/m2 subcutaneously d1-7 Mitoxantrone liposomes 20 mg/m2 intravenous d6 | Drug | CAG Group |
Primary outcome
ORR
Time frame: 6 months
Objective Response Rate
3 secondary outcomes
2 year PFS rate
Time frame: 2 years
2 year OS rate
Time frame: 2 years
DOR
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 16 Mar 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.
Questions about this trial
What is this clinical trial studying?
A study testing Cidapenem combined with azacitidine and mitoxantrone liposome (CAM) regimen in people with T Cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University.
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 21 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 16 Mar 2023. 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.
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 Wei XU, Doctor (025-68306034, 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: 6 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 16 Mar 2023.