Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a single-center, single-arm, prospective, phase II clinical trial designed to evaluate the efficacy and safety of Cidabenamine combined with Azacitidine as maintenance therapy following allogeneic peripheral blood hematopoietic stem cell transplantation in patients with high-risk peripheral T-cell lymphoma.During the screening/baseline period, informed consent will be obtained, and inclusion/exclusion criteria will be verified. The study plans to enroll 40 patients in each group. Enrolled patients will undergo demographic and medical history data collection, along with assessments including vital signs, physical examination, PET-CT, bone marrow aspiration smear, flow cytometry, lymphoid gene rearrangement, and bone marrow pathology.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cidabenamine combined with Azacitidine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cidabenamine, Azacitidine | Drug | In the study, Cidabenamine combined with Azacitidine are used as maintenance therapy following allogeneic peripheral blood hematopoietic stem cell transplantation in patients with high-risk peripheral T-cell lymphoma. |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | The probability of survival at years, measured from the date of transplantation to death from any cause. Patients who are still alive at the time of analysis will be censored on the last follow-up date. | up to 1 years for the 1y-OS and up to 2 years for the 2y-OS |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival (PFS) | Progression-Free Survival (PFS) is defined as the time from transpalntation until the first occurrence of disease progression or death from any cause, whichever occurs earlier. | up to 1 years for the 1y-PFS and up to 2 years for the 2y-PFS |
| non-relapse mortality (NRM) |
Not provided
Inclusion Criteria:
Aged 18 to 70 years, male or female.
Diagnosis of peripheral T-cell lymphoma (PTCL) according to the 2022 WHO criteria, including pathological subtypes such as PTCL not otherwise specified (PTCL-NOS), anaplastic large cell lymphoma (ALCL), and angioimmunoblastic T-cell lymphoma (AITL), but excluding hepatosplenic T-cell lymphoma; and meeting at least one of the following high-risk criteria:
① Stable Disease (SD) at the time of transplantation;
② Relapse after autologous hematopoietic stem cell transplantation (any disease status);
③ ≥ Partial Response 1 (PR1).
Underwent allogeneic peripheral blood hematopoietic stem cell transplantation for PTCL, with no restriction on donor type.
Presence of complete donor chimerism in the bone marrow (T-cell chimerism >95%).
ECOG performance status of 0 or 1.
Hematological function meeting the following requirements:
① Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L;
② Platelet count (PLT) ≥ 50 × 10⁹/L.
Patients must have the ability to understand and be willing to participate in the study and must provide signed informed consent.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xianmin song, MD | Contact | +862163240090 | shongxm@139.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General hospital,Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200080 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Death occurring after transplantation due to causes other than disease relapse, such as infection, organ toxicity, or transplantation-related complications. Deaths from any cause in the absence of prior relapse are considered events for this endpoint. |
| up to 1 year |
| cumulative relapse rates (CIR) | The cumulative probability of disease progression (including relapse or progression of the primary disease) within 1 years after transplantation, with non-progression-related death treated as a competing event. | up to 1 years for the 1y-CIR and up to 2 years for the 2y-CIR |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
Not provided
Not provided