Preconditioning With a Combination of Thiotepa, Cyclophosphamide, and Busulfan for Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of NK/T-Cell Lymphoma

Evaluation of the efficacy and safety of Thiotepa combined with Cyclophosphamide and Busulfan as conditioning regimen before allo-HSCT for the treatment of NK/T cell lymphoma

Study Overview

• Status: Not yet recruiting
• Conditions: NK T-Cell Lymphoma
• Intervention / Treatment: Drug: Thiotepa

Detailed Description

Although allo-HSCT brings certain survival benefits to patients with NK/T cell lymphoma, post-transplantation relapse remains the main cause of treatment failure and death. Therefore, it is crucial to further optimize the pre-transplantation conditioning regimen. Thiotepa is a non-specific cell cycle drug with good anti-tumor effects; it also has the dual functions of myeloablative and immunosuppressive effects, which can increase the implantation success rate, reduce the incidence of GVHD and recurrence rate. Currently, Thiotepa has become one of the preferred drugs for pre-transplantation conditioning in patients with primary central nervous system lymphoma and acute lymphoblastic leukemia. This study aims to add Thiotepa to the commonly used RIC conditioning regimen in order to explore an efficient and low-toxicity pre-transplantation conditioning regimen for allo-HSCT in NK/T cell lymphoma patients.

• Study Type: Interventional
• Enrollment (Estimated): 37
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xianming Song, M.D; Phone Number: +86 189 1802 9692; Email: shongxm@139.com
• Study Contact Backup: Name: Ruiqi Li, M.D; Email: ricky_li13@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age range: 18-70 years old, gender not restricted. 2. Patients diagnosed with NK/T cell lymphoma through histopathology or flow cytometry, 1) with stage III/IV patients receiving first-line or salvage treatment and achieving remission, 2) stage II patients with relapsed/refractory disease after salvage treatment achieving remission, 3) patients with NK cell lymphoma/leukemia receiving first-line or salvage treatment and achieving remission, 4) patients with relapsed/refractory disease. 3. Patients must have a suitable hematopoietic stem cell donor. 1) The related donor must have at least 5/10 HLA-A, -B, -C, -DQB1, and -DRB1 matching. 2) The unrelated donor must have at least 8/10 HLA-A, -B, -C, -DQB1, and -DRB1 matching. 4. HCT-specific comorbidity index score (HCT-CI) <= 2. 5. ECOG: 0-2 points. 6. Liver and kidney functions, as well as heart and lung functions, must meet the following requirements: 1) Serum creatinine <= 1.5 × ULN; 2) Cardiac function: Ejection fraction >= 50%; 3) Basal oxygen saturation > 92%; 4) Total bilirubin <= 1.5 × ULN; ALT and AST <= 2.0 × ULN; 5) Pulmonary function: DLCO (hemoglobin corrected) >= 40% and FEV1 >= 50%. 7. Patients must be capable of understanding and willing to participate in this study, and sign the informed consent form.

Exclusion Criteria:

1. Patients allergic to stietap, cyclophosphamide or busulfan or its components. 2. Any unstable systemic diseases: including but not limited to unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 3 months before screening), myocardial infarction (within 3 months before screening), congestive heart failure (NYHA classification ≥ III), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;patients with pulmonary hypertension. 3. Active and uncontrolled infections: hemodynamic instability related to infection, or new symptoms or signs of infection worsening, or new infection lesions found on imaging, persistent fever without exclusion of infection without symptoms or signs; 4. Grade 2 or higher epilepsy, paralysis, aphasia, new cerebral infarction, severe brain trauma, dementia, Parkinson's disease, schizophrenia 5. HIV-infected patients; 6. Patients with active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviral treatment; 2.patients with a risk of HBV activation, referring to those with positive hepatitis B surface antigen or core antibody but not receiving anti-hepatitis virus treatment; 7. Pregnant or lactating women; 8. Male and female individuals with reproductive capacity who are unwilling to use contraceptive methods during treatment and within 12 months after treatment; 9. Patients whose study investigators assess have other inadvisable inclusion conditions.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: treatment group

Drug: Thiotepa; The enrolled patients began the pre-treatment on day d-9. The pre-treatment regimen was as follows: Thiotepa 5mg/kg/d, from -9d to -8d (2d); Cyclophosphamide: 40 - 50mg/kg/d, from -7d to -6d (2d); Busulfan injection: for patients under 55 years old with HCT-CI score of 2 or below, use 3.2mg/kg/d from -5d to -3d (3d), for those over 55 years old with HCT-CI score above 2, use 3.2mg/kg/d from -5d to -4d (2d);

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
progression free survival	Two years after the transplantation

Secondary Outcome Measures

Outcome Measure	Time Frame
Cumulative recurrence rate	One year and two years after transplantation
Incidence of acute GVHD	within 180 days post-transplantation

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2025
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: November 29, 2025
• First Submitted That Met QC Criteria: November 29, 2025
• First Posted (Actual): December 11, 2025

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: November 29, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, Extranodal NK-T-Cell; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphoramides; Organophosphorus Compounds; Triethylenephosphoramide; Aziridines; Azirines; Thiotepa
• Other Study ID Numbers: SHSYXY-NT/T-TCB-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No