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New treatment option for Peripheral T Cell Lymphoma
Official title A Clinical Trial of Cidabenamine Plus Azacitidine to Prevent Post-Transplant Progression in High-Risk Peripheral T-Cell Lymphoma
ClinicalTrials.gov ID: NCT07389616
What this study is testing
What is Cidabenamine, Azacitidine?
Cidabenamine, Azacitidine is an investigational medicine, being studied as a potential treatment for peripheral t cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- 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.
You likely can't join if
- Known hypersensitivity to hypomethylating agents or Cidabenamine.
- Presence of grade II or higher active acute Graft-versus-Host Disease (GVHD).
- Presence of moderate or more severe chronic GVHD.
- Any unstable systemic disease, including but not limited to: unstable angina, cerebrovascular accident or transient ischemic attack (within 3 months...
- Active, uncontrolled infection, evidenced by any of the following: infection-related hemodynamic instability, worsening or new-onset infectious...
- Known HIV infection.
See the full eligibility 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...
- 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.
- Known hypersensitivity to hypomethylating agents or Cidabenamine.
- Presence of grade II or higher active acute Graft-versus-Host Disease (GVHD).
- Presence of moderate or more severe chronic GVHD.
- Any unstable systemic disease, including but not limited to: unstable angina, cerebrovascular accident or transient ischemic attack (within 3 months prior to screening), myocardial infarction (within 3 months prior to...
- Active, uncontrolled infection, evidenced by any of the following: infection-related hemodynamic instability, worsening or new-onset infectious symptoms/signs, radiologic evidence of a new infectious focus, or...
- Known HIV infection.
- Active Hepatitis B (HBV) or active Hepatitis C (HCV) requiring antiviral therapy.
- History of an autoimmune disease.
- Pregnant or lactating women.
- Concurrent participation in another treatment clinical trial and receiving other investigational drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.