Actively Recruiting
A Clinical Trial of Cidabenamine Plus Azacitidine to Prevent Post-Transplant Progression in High-Risk Peripheral T-Cell Lymphoma
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-02-05
40
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Age between 18 and 70 years, male or female
- Diagnosis of peripheral T-cell lymphoma (PTCL) based on 2022 WHO criteria, including subtypes PTCL-NOS, ALCL, and AITL, excluding hepatosplenic T-cell lymphoma
- Meets at least one high-risk criterion: Stable Disease at transplantation, relapse after autologous stem cell transplant, or partial response 1 or greater
- Underwent allogeneic peripheral blood hematopoietic stem cell transplantation for PTCL
- Complete donor chimerism in bone marrow with T-cell chimerism >95%
- ECOG performance status of 0 or 1
- Hematological function with absolute neutrophil count ≥1.0 × 10⁹/L and platelet count ≥50 × 10⁹/L
- Ability to understand and willing to participate with 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 such as unstable angina, recent stroke or heart attack (within 3 months), severe heart failure, pacemaker implantation, severe arrhythmia, liver, kidney, or metabolic diseases, or pulmonary hypertension
- Active, uncontrolled infection with signs like hemodynamic instability, worsening symptoms, new infectious focus, or persistent unexplained fever
- Known HIV infection
- Active Hepatitis B or C requiring antiviral treatment
- History of autoimmune disease
- Pregnant or breastfeeding women
- Participation in another interventional clinical trial with investigational drugs
AI-Screening
AI-Powered Screening
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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
CONTACT
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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