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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 groups

37 Participants
are divided into 1 treatment group
Group A: treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

progression free survival

Time frame
Two years after the transplantation

Secondary outcomes

1

Cumulative recurrence rate

Time frame
One year and two years after transplantation
2

Incidence of acute GVHD

Time frame
within 180 days post-transplantation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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