RecruitingPhase 2Phase 3NCT07389616

A Clinical Trial of Cidabenamine Plus Azacitidine to Prevent Post-Transplant Progression in High-Risk Peripheral T-Cell Lymphoma

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

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

40 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Peripheral T Cell Lymphoma

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a combination of two drugs — cidabenamine and azacitidine — can stop a type of blood cancer called peripheral T-cell lymphoma (PTCL) from coming back after a stem cell transplant. Researchers want to see if giving these drugs after transplant can keep the cancer in check for high-risk patients. **You may be eligible if...** - You are 18 to 70 years old - You have been diagnosed with peripheral T-cell lymphoma (PTCL), including subtypes like PTCL-NOS, ALCL, or AITL - You are considered high-risk (e.g., your cancer was only stable at transplant time, or you relapsed after a previous transplant) - You have already received an allogeneic (donor) stem cell transplant - Your bone marrow shows full donor cell replacement (complete chimerism) **You may NOT be eligible if...** - You have hepatosplenic T-cell lymphoma - You have active graft-versus-host disease (GVHD) that is not controlled - You have significant organ problems (liver, kidneys, heart, lungs) - You have an active serious infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCidabenamine, Azacitidine

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.