RIC With Thiotepa Combined With Bu/Flu/Ara-C in Allo-HSCT for Relapsed or Refractory PTCL.

Launched by XIANMIN SONG, MD · Jun 16, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with relapsed or refractory Peripheral T-Cell Lymphoma (PTCL), a type of cancer that affects a specific group of white blood cells. The study is testing a combination of medications given before a stem cell transplant to see how effective and safe this treatment is. Patients will receive a specific regimen of drugs starting a week before the transplant, and the main goal is to see how many people are still free of cancer one and two years after the procedure.

To participate in this trial, patients must be between 18 and 70 years old, have been diagnosed with PTCL, and need to have a suitable donor for the stem cell transplant. They should also be in good overall health, meaning their other organs like the liver and kidneys are functioning well. Throughout the study, participants can expect regular check-ups, including blood tests and imaging, to monitor their health and how well the treatment is working. It's important to know that this study is currently recruiting participants, so those who meet the criteria can consider joining to help advance treatment options for this challenging cancer.

Gender

ALL

Eligibility criteria

• Inclusion 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 chemotherapy but disease progressed，and relapse after hematopoietic stem cell transplantation;Refractory: Except ALK+ anaplastic large cell lymphoma （ALCL), the tumor shrank \< 50% or progressive disease after 4 courses of standard chemotherapy, or not achieve CR after 6 courses of standard chemotherapy;Not suitable for or refusing autologous hematopoietic stem cell transplantation.
• • 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, and -DRB1
• • 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 \> 92%;Total bilirubin ≤ 2.0 x ULN; ALT and AST ≤ 2.0 x ULN，AKP ≤ 2.0 x ULN;Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40% and FEV1 (Forced Expiratory Volume in 1 second) ≥ 50%
• • Patients must have the ability to understand and be willing to participate in this study and sign an informed consent form
• Exclusion Criteria:
• • 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 treated localized prostate cancer or ductal carcinoma in situ
• • 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 months prior to screening, congestive heart failure (New York Heart Association \[NYHA\] class ≥ III), severe arrhythmias requiring drug treatment after pacemaker implantation, significant liver, kidney, or metabolic diseases, and pulmonary arterial hypertension.
• • 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 symptoms of infection.
• • 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.