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

Phase 2

Recruiting

• Conditions: Peripheral T Cell Lymphoma
• Interventions: Drug: Thiotepa

• Registration Number: NCT06468267
• Lead Sponsor: Xianmin Song, MD

Brief Summary

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....

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-16
• Study First Posted: 2024-06-21
• Status Verified: 2024-07
• Study Start: 2024-07-15
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01
• Primary Completion: 2026-07-15
• Study Completion: 2026-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intervention arm	Thiotepa	Participants will receive allogenetic hematopoietic stem cell transplantation (allo-HSCT) with the reduced intensity conditioning regimen including thiotepa(5mg / kg / d-7d ( 1d )), fludarabine (30mg / m2 / d, -6d--2d ( 5d )), Ara-C (1g / m2 / d, -6d--2d ( 5d )), and busulfan(3.2mg / kg / d, -4d-3d ( 2d )).

Primary Outcome Measures

Name	Time	Method
1y and 2y-progression-free survival (PFS)	up to 1 years for the 1y-PFS and up to 2 years for the 2y-PFS	1-year and 2-year progression-free survival (PFS) rates post-transplant

Secondary Outcome Measures

Name	Time	Method
1y and 2y-overall survival (OS)	up to 1 years for the 1y-OS and up to 2 years for the 2y-OS	overall survival (OS) at 1 year and 2 years post-transplant
acute graft-versus-host disease (aGVHD)	up to 180 days	acute graft-versus-host disease (aGVHD) within 180 days post-transplant
1y and 2y-cumulative relapse rates (CIR)	up to 1 years for the 1y-CIR and up to 2 years for the 2y-CIR	cumulative relapse rates (CIR) at 1 year and 2 years post-transplant
cumulative incidence of chronic GVHD	up to 2 years	cumulative incidence of chronic GVHD at 2 years post-transplant
CMV and EBV reactivation	up to 1 year	the incidence of CMV and EBV reactivation within 1 year
non-relapse mortality (NRM)	up to 2 years	non-relapse mortality (NRM) at 2 years post-transplant
graft-versus-host disease-free, relapse-free survival (GRFS)	up to 2 years	graft-versus-host disease-free, relapse-free survival (GRFS) at 2 years post-transplant

Trial Locations

Locations (1)

Shanghai General Hospital; 🇨🇳 Shanghai, Shanghai, China