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

NCT07276737 | Not Yet Recruiting Phase 2

• 1 other identifier: SHSYXY-NT/T-TCB-2025
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

NK T-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• progression free survival

  Two years after the transplantation

Secondary Outcomes (2)

• Cumulative recurrence rate

  One year and two years after transplantation

• Incidence of acute GVHD

  within 180 days post-transplantation

Study Arms (1)

treatment group

EXPERIMENTAL

Drug: Thiotepa

Interventions

Thiotepa DRUG

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);

treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

Thiotepa

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Phosphoramides; Organophosphorus Compounds; Organic Chemicals; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Xianming Song, M.D

CONTACT

+86 189 1802 9692; shongxm@139.com

Ruiqi Li, M.D

CONTACT

ricky_li13@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 29, 2025
• First Posted: December 11, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share