BridgeMD
New treatment option for Peripheral T Cell Lymphoma
Official title RIC With Thiotepa Combined With Bu/Flu/Ara-C in Allo-HSCT for Relapsed or Refractory PTCL.
ClinicalTrials.gov ID: NCT06468267
What this study is testing
What is Thiotepa?
Thiotepa is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for peripheral t cell lymphoma.
Also referred to as fludarabine, busulfan.
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 that evaluates the efficacy and safety of an reduced-intensity conditioning (RIC) regimen with thiotepa combined with busulfan, fludarabine, and cytarabine for allogeneic hematopoietic stem cell transplantation in the treatment of relapse and refratory peripheral T-cells lymphoma. The conditioning regimen includes thiotepa at a dose of 5mg/kg/d at d -7 (1 day), fludarabine at 30mg/m2/d from d -6 to d -2 (5 days), cytarabine at 1g/m2/d from d -6 to d -2 (5 days), and busulfan at 3.2mg/kg/d from d -4 to d -3 (2 days).
- Phase 2: a mid-size study of how well it works
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
- Age between 18 and less than 70 years, regardless of gender
- Peripheral T-cell lymphoma (PTCL) was diagnosed according to the 2016 WHO criteria and met any of the following criteria: Relapse: Except ALK+...
- Patients must have a suitable hematopoietic stem cell donor:Related donors must have at least 5/10 matches for HLA-A, -B, -C, -DQB1, and -...
- Hematopoietic cell transplantation comorbidity index (HCT-CI) score ≤ 2
- ECOG (Eastern Cooperative Oncology Group) performance status: 0-2
You likely can't join if
- PTCL patients did not meet the criteria of relapse / refractory.
- Refuse to adopt allegeneic hematopoietic stem cell transplantation.
- History of malignancies other than lymphoid tumors within the 5 years prior to screening, except for adequately treated in situ cervical cancer...
- ECOG ≥ 3.
- HCT-CI score ≥ 3.
- Any unstable systemic diseases, including but not limited to unstable angina, recent cerebrovascular accidents or transient ischemic attacks within...
See the full eligibility criteria
- Age between 18 and less than 70 years, regardless of gender
- Peripheral T-cell lymphoma (PTCL) was diagnosed according to the 2016 WHO criteria and met any of the following criteria: Relapse: Except ALK+ anaplastic large cell lymphoma （ALCL), CR was achieved by standard...
- Patients must have a suitable hematopoietic stem cell donor:Related donors must have at least 5/10 matches for HLA-A, -B, -C, -DQB1, and - DRB1;Unrelated donors must have at least 8/10 matches for HLA-A, -B, -C, -DQB1...
- Hematopoietic cell transplantation comorbidity index (HCT-CI) score ≤ 2
- ECOG (Eastern Cooperative Oncology Group) performance status: 0-2
- Adequate liver, kidney, and cardiopulmonary function, meeting the following requirements:Serum creatinine ≤ 1.5x ULN (the upper limit of normal);Cardiac function: Ejection fraction ≥ 50%;Baseline oxygen saturation \>...
- Patients must have the ability to understand and be willing to participate in this study and sign an informed consent form
- PTCL patients did not meet the criteria of relapse / refractory.
- Refuse to adopt allegeneic hematopoietic stem cell transplantation.
- History of malignancies other than lymphoid tumors within the 5 years prior to screening, except for adequately treated in situ cervical cancer, basal cell carcinoma, squamous cell carcinoma of the skin, and curatively...
- ECOG ≥ 3.
- HCT-CI score ≥ 3.
- Any unstable systemic diseases, including but not limited to unstable angina, recent cerebrovascular accidents or transient ischemic attacks within the 3 months prior to screening, myocardial infarction within the 3...
- Active, uncontrolled infections, including those associated with hemodynamic instability, new or worsening infection symptoms or signs, new infectious lesions on imaging, or persistent unexplained fever without signs or...
- HIV-infected individuals.
- Active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviral therapy.
- History of autoimmune diseases
- Pregnant or breastfeeding women.
- Fertile males and females unwilling to use contraception during the treatment period and for 12 months after treatment.
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.