BuCy Vs. TBICy for Allo-HSCT in T-ALL Patients

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-55
SponsorThe First Affiliated Hospital of Soochow University

About this trial

T-cell acute lymphoblastic leukemia (T-ALL), a hematological malignant neoplasm of immature T cells, accounting for a morbidity of 10-15% among pediatric and 20-25% among adult patients of ALL. Despite the application of improved intensive therapies, the overall survival (OS) of T-ALL patients is still unsatisfactory, with a 5-year OS rate of less than 60% in adults and 85% in children. Over the past few decades, allogeneic hematopoietic stem-cell transplantation (allo-HSCT) has emerged as a potential and the most likely curative treatment for patients with high-risk hematological malignant neoplasms, and it has been proven that allo-HSCT could hold the potential to improve the prognosis of T-ALL patients and may even cure T-ALL.

The two most common myeloablative conditioning regimens for T-ALL patients with allo-HSCT were total body irradiation (TBI) plus cyclophosphamide (TBI-Cy) and busulfan (Bu) plus cyclophosphamide (BuCy). The most common use conditioning regimen for ALL patients is the TBI-Cy conditioning regimen over other hematological malignancy patients because TBI possess potent and distinct anti-leukemic effects, particularly in organs not easily affected by systemic chemotherapy and intense immunosuppressive effects. However, TBI-based conditioning regimens may cause a high risk of cataracts, interstitial pneumonitis (IP), engraftment failure and even subsequent malignant neoplasms (SMNs). To avoid these disadvantages, intravenous Bu replaced TBI as a part of conditioning.

Extensive studies have shown that allo-HSCT with conditioning regimens based on TBI could benefit survival compared with conditioning regimens based on chemotheraphy in treating ALL. We retrospectively analyzed post-10-year data from T-ALL patients from two transplant centers, and all the databases were used to eliminate confounding factors via PSM. We demonstrated that the TBI-Cy conditioning regimen had inferior efficacy to the BuCy conditioning regimen, especially for T-ALL patients who were children, refractory, had extramedullary disease before transplantation, had active disease or an MRD-positive status at allo-HSCT, or who received haplo-HSCT.

Eligibility criteria

Qualifiers

T-ALL patients aged > 2 years and ≤55 years;

For the first time accept allo-HSCT;

With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3; 4. Signing an informed consent form, having the ability to comply with study and follow-up procedures.

Disqualifiers

With other malignancies;

With a previous history of autologous hematopoietic cell transplantation, allogeneic hematopoietic cell transplantation or chimeric antigen receptor T cell therapy;

With uncontrolled infection intolerant to haploidentical hematopoietic cell transplantation;

With severe organ dysfunction;

Trial design

Treatments tested in this trial

  • TBICy
  • BuCy

Treatment groups

430 Participants
are divided into 2 treatment groups

Sponsors and collaborators

The First Affiliated Hospital of Soochow University

Lead sponsor

Children's Hospital of Soochow University

Collaborator

Ruijin Hospital

Collaborator

Nanfang Hospital, Southern Medical University

Collaborator

Fujian Medical University Union Hospital

Collaborator

First Affiliated Hospital Xi'an Jiaotong University

Collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Collaborator

Zhejiang University

Collaborator

Anhui Provincial Hospital

Collaborator