Actively Recruiting
A Clinical Study of Cidabenamine Combined With Azacitidine for Preventing Progression in High-Risk Peripheral T-Cell Lymphoma After Allogeneic Peripheral Blood Hematopoietic Stem Cell Transplantation
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-02-05
40
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining Cidabenamine with Azacitidine as maintenance therapy after allogeneic peripheral blood hematopoietic stem cell transplantation in patients with high-risk peripheral T-cell lymphoma. This phase II clinical trial aims to prevent disease progression in this group of patients. The study is conducted at a single center and plans to enroll 40 patients, focusing on those meeting specific high-risk criteria and transplant conditions. Participants will receive the combination of Cidabenamine and Azacitidine following their transplant. Before treatment, patients will undergo screening including consent, eligibility verification, and collection of demographic and medical history data. Assessments such as vital signs, physical exams, PET-CT scans, bone marrow tests, flow cytometry, lymphoid gene rearrangement analysis, and bone marrow pathology will be performed to monitor health and disease status. Throughout the study, researchers will track overall survival up to 2 years as the primary outcome. Secondary outcomes include progression-free survival, non-relapse mortality, and relapse rates within 1 to 2 years. Patients will be closely monitored for treatment responses and safety. The total participation duration spans from screening through follow-up assessments, allowing comprehensive evaluation of the maintenance therapy's impact.
CONDITIONS
Brief Title
A Clinical Trial of Cidabenamine Plus Azacitidine to Prevent Post-Transplant Progression in High-Risk Peripheral T-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years, male or female
- Diagnosed with peripheral T-cell lymphoma (PTCL) per 2022 WHO criteria, including PTCL-NOS, ALCL, or AITL, excluding hepatosplenic T-cell lymphoma
- Meets at least one high-risk criterion: Stable Disease at transplant, relapse after autologous transplant, or partial response 1
- Underwent allogeneic peripheral blood hematopoietic stem cell transplantation for PTCL
- Complete donor chimerism in bone marrow (T-cell chimerism >95%)
- ECOG performance status of 0 or 1
- Adequate hematological function: ANC ≥ 1.0 × 10⁹/L, Platelets ≥ 50 × 10⁹/L
- Able to understand and willing to provide signed informed consent
You will not qualify if you...
- Known hypersensitivity to hypomethylating agents or Cidabenamine
- Grade II or higher active acute Graft-versus-Host Disease (GVHD)
- Moderate or more severe chronic GVHD
- Unstable systemic diseases, including unstable angina, recent stroke or heart attack, severe heart failure, pacemaker status, severe arrhythmia, liver, kidney, metabolic diseases, or pulmonary hypertension
- Active, uncontrolled infections with hemodynamic instability or persistent fever without clear cause
- Known HIV infection
- Active Hepatitis B or C requiring antiviral therapy
- History of autoimmune disease
- Pregnant or lactating women
- Concurrent participation in another interventional clinical trial receiving investigational drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive maintenance therapy with Cidabenamine combined with Azacitidine following allogeneic peripheral blood hematopoietic stem cell transplantation to prevent progression of high-risk peripheral T-cell lymphoma.
Regular visits during treatment as per protocol
Trial Site Locations
Total: 1 location
1
Shanghai General hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
Research Team
X
xianmin song, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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