Relapsed/Refractory Peripheral T-cell LymphomaNCT06211881
Chi-GVM Regimen for the Treatment of R/R PTCL
A study testing Chi-GVM in people with Relapsed/Refractory 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 heterogeneous group of lymphoproliferative diseases caused by mature T cells, accounting for approximately 10% of non-Hodgkin lymphomas (NHL). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed/Refractory Peripheral T-cell Lymphoma
- What is being tested?
- Chi-GVM
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2023to 30 Sep 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. R/R PTCL confirmed by pathological tissue [including peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and ALK+ anaplastic large cell lymphoma (ALCL) , ALK-ALCL, monotypic epithelial intestinal T-cell lymphoma (MEITL), etc.], the diagnostic criteria refer to the 2022 WHO diagnostic criteria; 2. Have had at least one previous systemic treatment [including chemotherapy, autologous hematopoietic stem cell transplantation (ASCT) ), etc.] Patients who have no remission or relapse after remission; 3. Sign written informed consent and be able to comply with the visits and related procedures specified in the protocol; 4. Whole-body PET/CT performed 28 days before study enrollment must be At least 1 evaluable or measurable lesion that meets the Lugano2014 criteria: lymph node lesions, measurable lymph nodes must have a long diameter >1.5 cm; non-lymph node lesions, measurable extranodal lesions must have a long diameter >1.0 cm; 5. ECOG PS score: 0~2; 6. Have adequate organ and bone marrow function, defined as follows: neutrophil count ≥1.5×109/L, platelet count ≥75×109/L, hemoglobin ≥80 g/L (neutrophil count in patients with bone marrow involvement) The granulocyte count can be relaxed to ≥1.0×109/L, the platelet count can be relaxed to ≥50×109/L, and the hemoglobin can be relaxed to ≥75 g/L); 7. Liver and renal function: Serum creatinine (Cr) ≤1.5 times the upper limit of normal values; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal values (≤5 times the upper limit of normal values for patients with liver invasion); total bilirubin (TBIL) ) ≤ 1.5 times the upper limit of normal value (for patients with liver invasion ≤ 3 times the upper limit of normal value); 8. Expected survival time more than 3 months; 9. Age 18~75 years old.
Who cannot join
- 1. The subject's previous anti-tumor treatment history meets one of the following conditions:
- Those who have received mitoxantrone or Mitoxantrone Hydrochloride Liposome in the past;
- Previously received treatment with doxorubicin or other anthracyclines, with a total cumulative dose of doxorubicin >360 mg/m2 (converted from other anthracyclines, 1 mg of doxorubicin is equivalent to 2 mg of epirubicin );
- Patients who have received ASCT within 100 days of first medication, or have received allogeneic hematopoietic stem cell transplantation (Allo-SCT);
- Within 4 weeks before using this study drug for the first time, you have received anti-tumor treatment (including chemotherapy, targeted therapy, hormone therapy, taking traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received clinical trial drugs.
- 2. Have a hypersensitivity reaction to any study drug or its ingredients; 3. Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.); 4. Heart function and disease meet one of the following conditions:
Show all 13Show fewer
- Long QTc syndrome or QTc interval >480 ms;
- Complete left bundle branch block, II or III degree atrioventricular block;
- Severe, uncontrolled arrhythmia requiring drug treatment;
- New York Heart Association classification ≥ III;
- The cardiac left ventricular ejection fraction (LVEF) is less than 50%;
- Have a history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, clinically severe pericardial disease, or acute ischemic or active disease within 6 months before recruitment Electrocardiographic evidence of sexual conduction system abnormalities.
- 5. Active infection of hepatitis B and hepatitis C (hepatitis B virus surface antigen is positive and hepatitis B virus DNA exceeds 1×103 copies/mL; hepatitis C virus RNA exceeds 1×103 copies/mL); 6. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 7. Have suffered from other malignant tumors in the past or at the same time (except for non-melanoma basal cell carcinoma of the skin, breast/cervical carcinoma in situ and other malignant tumors that have been effectively controlled without treatment in the past 5 years); 8. Suffer from primary or secondary central nervous system (CNS) lymphoma or have a history of CNS lymphoma at the time of recruitment; 9. Pregnant, lactating women and patients of childbearing age who are unwilling to take contraceptive measures; 10. People with mental disorders/people unable to obtain informed consent; 11.Those who are judged by the researcher to be unsuitable to participate in this trial
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: Chidamide Combined With Gemcitabine, Vinorelbine, and Mitoxantrone Hydrochloride Liposome (Chi-GVM) Regimen for the Treatment of Relapsed/Refractory (R/R) Peripheral T-cell Lymphoma (PTCL) :A Multicenter, Open-label, Single-arm Study
Peripheral T-cell lymphoma (PTCL) is a heterogeneous group of lymphoproliferative diseases caused by mature T cells, accounting for approximately 10% of non-Hodgkin lymphomas (NHL). PTCLs have a worse prognosis than aggressive B-cell lymphomas; they are less responsive to standard anthracycline-based chemotherapy regimens and responses are less durable. In an analysis of 341 patients with newly diagnosed PTCL who received anthracycline chemotherapy, 3-year PFS and OS rates were 32% and 52%, respectively, significantly inferior to matched patients with diffuse large B-cell lymphoma (DLBCL).And patients who received consolidative hematopoietic cell transplantation (HCT) had no significant benefit. The prognosis of relapsed/refractory (R/R) patients is even worse. Among the 420 evaluable R/R PTCL patients in the COMPLETE registration study, the median OS of R/R patients were 29 months and 12 months respectively . There is still no effective second-line regimen that can improve patient survival, so treatment options urgently need to be optimized.We designed a randomized, prospective, multi-center phase II clinical trial to explore the efficacy of chidamide combined with gemcitabine, vinorelbine and Mitoxantrone Hydrochloride Liposome (Chi-GVM) in the treatment of patients with R/R PTCL. We expected to further improve ORR, PFS and OS.
Read the detailed description
Peripheral T-cell lymphoma (PTCL) is a heterogeneous group of lymphoproliferative diseases caused by mature T cells, accounting for approximately 10% of non-Hodgkin lymphomas (NHL). Peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) is the most common subtype, accounting for approximately 26%. This was followed by angioimmunoblastic T-cell lymphoma (AITL; 19%), anaplastic large cell lymphoma (ALCL, ALK)-positive (7%), ALK-negative (6%), and enteropathy-associated T-cell lymphoma ( EATL) .
PTCLs have a worse prognosis than aggressive B-cell lymphomas; they are less responsive to standard anthracycline-based chemotherapy regimens and responses are less durable. In an analysis of 341 patients with newly diagnosed PTCL who received anthracycline chemotherapy, 3-year PFS and OS rates were 32% and 52%, respectively, significantly inferior to matched patients with diffuse large B-cell lymphoma (DLBCL).And patients who received consolidative hematopoietic cell transplantation (HCT) had no significant benefit. The prognosis of relapsed/refractory (R/R) patients is even worse. Among the 420 evaluable R/R PTCL patients in the COMPLETE registration study, the median OS of R/R patients were 29 months and 12 months respectively . There is still no effective second-line regimen that can improve patient survival, so treatment options urgently need to be optimized.
Histone deacetylase (HDAC) inhibitors such as belinostat, romidepsin, etc. have been confirmed to show good efficacy in R/R AITL;Chinise original drug Chidamide is mainly targeted at Class I HDAC inhibitors (HDACi) of HDAC subtypes 1, 2, and 3 and class IIb subtype 10 have the regulatory effect on abnormal epigenetic functions of tumors. It triggers chromatin remodeling by inhibiting related HDAC isoforms to increase the acetylation level of chromatin histones, resulting in changes in gene expression (ie, epigenetic changes) targeting multiple signaling pathways, thereby inhibiting tumor cells cycle, induce apoptosis of tumor cells, and at the same time have overall regulatory activity on cellular immunity, inducing and enhancing the tumor killing effect mediated by natural killer cells (NK) and antigen-specific cytotoxic T cells (CTL). Chidamide also induces tumor stem cell differentiation and reverses the epithelial-mesenchymal phenotypic transition (EMT) of tumor cells through epigenetic regulation mechanisms, thereby restoring the sensitivity of drug-resistant tumor cells to drugs and inhibiting tumor metastasis. play a potential role in recurrence and other aspects. The above unique mechanism of action characteristics lay the foundation for the combined application of chidamide and other chemotherapy drugs in tumor treatment. Its phase II clinical study explored the effectiveness and safety of chidamide monotherapy in patients with R/R PTCL. The objective response rate (ORR) assessed by the investigators was 29.1%, and the median duration of response (DOR) was 9.9 months, and is well tolerated.Chidamide has been included in the medical insurance indications for patients with relapsed or refractory PTCL who have received at least one systemic chemotherapy in the past. However, single drug is still not effective in patients with nTFHL and needs to be combined with other drugs.
Gemcitabine, dexamethasone, and cisplatin (GDP) combined with autologous hematopoietic stem cell transplantation (ASCT) can effectively treat patients with R/R PTCL, with an ORR of 72% to 80% and a CR of 47% to 48%. Among patients who subsequently underwent ASCT, 2-year post-transplant OS was 53%. A retrospective analysis showed that the gemcitabine, vinorelbine, and doxorubicin (GND) regimen was effective and well tolerated in patients with R/RT cell lymphoma (n=49; 28 patients with PTCL-NOS), with ORR was 65%, the median OS was 36 months, and the 5-year estimated OS rate was 32%.
- Being tested
- Chi-GVM
- 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.
Chi-GVMDrug
Also called Chidamide Combined With Gemcitabine, Vinorelbine, and Mitoxantrone Hydrochloride Liposome
Chi-GVM regimen (every 21 days is a treatment cycle):
Chidamide 20 mg orally;gemcitabine 1g/m2, twice a week, intravenous infusion on day 1, vinorelbine 20 mg/m2, infusion on day 1; Mitoxantrone Hydrochloride Liposome12 mg/m2, intravenous infusion on day 1; Chidamide maintenance therapy: 20 mg orally twice a week/28 days/cycle.
| Study group | Role | What they receive |
|---|---|---|
| Chi-GVM | Experimental | Chi-GVM regimen (every 21 days is a treatment cycle):
Chidamide 20 mg orally;gemcitabine 1g/m2, twice a week, intravenous infusion on day 1, vinorelbine 20 mg/m2, infusion on day 1; Mitoxantrone Hydrochloride Liposome12 mg/m2, intravenous infusion on day 1; Chidamide maintenance therapy: 20 mg orally twice a week/28 days/cycle. Receives: Drug: Chi-GVM |
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 (3)
DoR
Duration of Response
Measured: 2 years
2-years OS
2-year overall survival
Measured: 2 years
2-years PFS
2-year progression-free survival
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 posted18 Jan 2024
- Study start25 Oct 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory 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
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- wei Xu, Doctor, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211881
- Sponsor's protocol ID
- 2023-SR-519
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 18 Jan 2024
- 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 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chidamide Combined With Gemcitabine, Vinorelbine, and Mitoxantrone Hydrochloride Liposome (Chi-GVM) Regimen for the Treatment of Relapsed/Refractory (R/R) Peripheral T-cell Lymphoma (PTCL) :A Multicenter, Open-label, Single-arm Study
- ClinicalTrials.gov ID
- NCT06211881
- Acronym / sponsor ID
- 2023-SR-519
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 18 Jan 2024 (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 heterogeneous group of lymphoproliferative diseases caused by mature T cells, accounting for approximately 10% of non-Hodgkin lymphomas (NHL). PTCLs have a worse prognosis than aggressive B-cell lymphomas; they are less responsive to standard anthracycline-based chemotherapy regimens and responses are less durable. In an analysis of 341 patients with newly diagnosed PTCL who received anthracycline chemotherapy, 3-year PFS and OS rates were 32% and 52%, respectively, significantly inferior to matched patients with diffuse large B-cell lymphoma (DLBCL).And patients who received consolidative hematopoietic cell transplantation (HCT) had no significant benefit. The prognosis of relapsed/refractory (R/R) patients is even worse. Among the 420 evaluable R/R PTCL patients in the COMPLETE registration study, the median OS of R/R patients were 29 months and 12 months respectively . There is still no effective second-line regimen that can improve patient survival, so treatment options urgently need to be optimized.We designed a randomized, prospective, multi-center phase II clinical trial to explore the efficacy of chidamide combined with gemcitabine, vinorelbine and Mitoxantrone Hydrochloride Liposome (Chi-GVM) in the treatment of patients with R/R PTCL. We expected to further improve ORR, PFS and OS.
Detailed description
Peripheral T-cell lymphoma (PTCL) is a heterogeneous group of lymphoproliferative diseases caused by mature T cells, accounting for approximately 10% of non-Hodgkin lymphomas (NHL). Peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) is the most common subtype, accounting for approximately 26%. This was followed by angioimmunoblastic T-cell lymphoma (AITL; 19%), anaplastic large cell lymphoma (ALCL, ALK)-positive (7%), ALK-negative (6%), and enteropathy-associated T-cell lymphoma ( EATL) .
PTCLs have a worse prognosis than aggressive B-cell lymphomas; they are less responsive to standard anthracycline-based chemotherapy regimens and responses are less durable. In an analysis of 341 patients with newly diagnosed PTCL who received anthracycline chemotherapy, 3-year PFS and OS rates were 32% and 52%, respectively, significantly inferior to matched patients with diffuse large B-cell lymphoma (DLBCL).And patients who received consolidative hematopoietic cell transplantation (HCT) had no significant benefit. The prognosis of relapsed/refractory (R/R) patients is even worse. Among the 420 evaluable R/R PTCL patients in the COMPLETE registration study, the median OS of R/R patients were 29 months and 12 months respectively . There is still no effective second-line regimen that can improve patient survival, so treatment options urgently need to be optimized.
Histone deacetylase (HDAC) inhibitors such as belinostat, romidepsin, etc. have been confirmed to show good efficacy in R/R AITL;Chinise original drug Chidamide is mainly targeted at Class I HDAC inhibitors (HDACi) of HDAC subtypes 1, 2, and 3 and class IIb subtype 10 have the regulatory effect on abnormal epigenetic functions of tumors. It triggers chromatin remodeling by inhibiting related HDAC isoforms to increase the acetylation level of chromatin histones, resulting in changes in gene expression (ie, epigenetic changes) targeting multiple signaling pathways, thereby inhibiting tumor cells cycle, induce apoptosis of tumor cells, and at the same time have overall regulatory activity on cellular immunity, inducing and enhancing the tumor killing effect mediated by natural killer cells (NK) and antigen-specific cytotoxic T cells (CTL). Chidamide also induces tumor stem cell differentiation and reverses the epithelial-mesenchymal phenotypic transition (EMT) of tumor cells through epigenetic regulation mechanisms, thereby restoring the sensitivity of drug-resistant tumor cells to drugs and inhibiting tumor metastasis. play a potential role in recurrence and other aspects. The above unique mechanism of action characteristics lay the foundation for the combined application of chidamide and other chemotherapy drugs in tumor treatment. Its phase II clinical study explored the effectiveness and safety of chidamide monotherapy in patients with R/R PTCL. The objective response rate (ORR) assessed by the investigators was 29.1%, and the median duration of response (DOR) was 9.9 months, and is well tolerated.Chidamide has been included in the medical insurance indications for patients with relapsed or refractory PTCL who have received at least one systemic chemotherapy in the past. However, single drug is still not effective in patients with nTFHL and needs to be combined with other drugs.
Gemcitabine, dexamethasone, and cisplatin (GDP) combined with autologous hematopoietic stem cell transplantation (ASCT) can effectively treat patients with R/R PTCL, with an ORR of 72% to 80% and a CR of 47% to 48%. Among patients who subsequently underwent ASCT, 2-year post-transplant OS was 53%. A retrospective analysis showed that the gemcitabine, vinorelbine, and doxorubicin (GND) regimen was effective and well tolerated in patients with R/RT cell lymphoma (n=49; 28 patients with PTCL-NOS), with ORR was 65%, the median OS was 36 months, and the 5-year estimated OS rate was 32%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chi-GVM | Experimental | Drug: Chi-GVMChi-GVM regimen (every 21 days is a treatment cycle): Chidamide 20 mg orally;gemcitabine 1g/m2, twice a week, intravenous infusion on day 1, vinorelbine 20 mg/m2, infusion on day 1; Mitoxantrone Hydrochloride Liposome12 mg/m2, intravenous infusion on day 1; Chidamide maintenance therapy: 20 mg orally twice a week/28 days/cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. R/R PTCL confirmed by pathological tissue [including peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and ALK+ anaplastic large cell lymphoma (ALCL) , ALK-ALCL, monotypic epithelial intestinal T-cell lymphoma (MEITL), etc.], the diagnostic criteria refer to the 2022 WHO diagnostic criteria; 2. Have had at least one previous systemic treatment [including chemotherapy, autologous hematopoietic stem cell transplantation (ASCT) ), etc.] Patients who have no remission or relapse after remission; 3. Sign written informed consent and be able to comply with the visits and related procedures specified in the protocol; 4. Whole-body PET/CT performed 28 days before study enrollment must be At least 1 evaluable or measurable lesion that meets the Lugano2014 criteria: lymph node lesions, measurable lymph nodes must have a long diameter >1.5 cm; non-lymph node lesions, measurable extranodal lesions must have a long diameter >1.0 cm; 5. ECOG PS score: 0~2; 6. Have adequate organ and bone marrow function, defined as follows: neutrophil count ≥1.5×109/L, platelet count ≥75×109/L, hemoglobin ≥80 g/L (neutrophil count in patients with bone marrow involvement) The granulocyte count can be relaxed to ≥1.0×109/L, the platelet count can be relaxed to ≥50×109/L, and the hemoglobin can be relaxed to ≥75 g/L); 7. Liver and renal function: Serum creatinine (Cr) ≤1.5 times the upper limit of normal values; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal values (≤5 times the upper limit of normal values for patients with liver invasion); total bilirubin (TBIL) ) ≤ 1.5 times the upper limit of normal value (for patients with liver invasion ≤ 3 times the upper limit of normal value); 8. Expected survival time more than 3 months; 9. Age 18~75 years old.
Key exclusion criteria (13 listed)
- 1. The subject's previous anti-tumor treatment history meets one of the following conditions:
- 2. Have a hypersensitivity reaction to any study drug or its ingredients; 3. Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.); 4. Heart function and disease meet one of the following conditions:
- 5. Active infection of hepatitis B and hepatitis C (hepatitis B virus surface antigen is positive and hepatitis B virus DNA exceeds 1×103 copies/mL; hepatitis C virus RNA exceeds 1×103 copies/mL); 6. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 7. Have suffered from other malignant tumors in the past or at the same time (except for non-melanoma basal cell carcinoma of the skin, breast/cervical carcinoma in situ and other malignant tumors that have been effectively controlled without treatment in the past 5 years); 8. Suffer from primary or secondary central nervous system (CNS) lymphoma or have a history of CNS lymphoma at the time of recruitment; 9. Pregnant, lactating women and patients of childbearing age who are unwilling to take contraceptive measures; 10. People with mental disorders/people unable to obtain informed consent; 11.Those who are judged by the researcher to be unsuitable to participate in this trial
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 |
|---|---|---|
| Chi-GVMAlso: Chidamide Combined With Gemcitabine, Vinorelbine, and Mitoxantrone Hydrochloride LiposomeChi-GVM regimen (every 21 days is a treatment cycle): Chidamide 20 mg orally;gemcitabine 1g/m2, twice a week, intravenous infusion on day 1, vinorelbine 20 mg/m2, infusion on day 1; Mitoxantrone Hydrochloride Liposome12 mg/m2, intravenous infusion on day 1; Chidamide maintenance therapy: 20 mg orally twice a week/28 days/cycle. | Drug | Chi-GVM |
Primary outcome
ORR
Time frame: 1 year
overall response rate
3 secondary outcomes
DoR
Time frame: 2 years
2-years OS
Time frame: 2 years
2-years PFS
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 18 Jan 2024.
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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.
wei Xu, Doctor principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chi-GVM in people with Relapsed/Refractory 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 1 inclusion and 13 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 18 Jan 2024. 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, Doctor (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 18 Jan 2024.