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

Phase 3

Not yet recruiting

• Conditions: T-Cell Lymphocytic Leukemia; ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; Total Body Irradiation; Chemotherapy
• Interventions: Biological: TBICy; Biological: BuCy

• Registration Number: NCT06673459
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-11-02
• Study First Submitted QC: 2024-11-02
• Last Update Submitted: 2024-11-02
• Study First Posted: 2024-11-05
• Last Update Posted: 2024-11-05
• Study Start: 2024-12-01
• Primary Completion: 2029-11-30
• Study Completion: 2029-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

1. T-ALL patients aged > 2 years and ≤55 years;
2. For the first time accept allo-HSCT;
3. 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.

Exclusion Criteria

1. With other malignancies;
2. With a previous history of autologous hematopoietic cell transplantation, allogeneic hematopoietic cell transplantation or chimeric antigen receptor T cell therapy;
3. With uncontrolled infection intolerant to haploidentical hematopoietic cell transplantation;
4. With severe organ dysfunction;
5. In pregnancy or lactation period;
6. With any conditions not suitable for the trial (investigators' decision).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TBICy	TBICy	Patients enrolled in this arm will receive total body irradiation plus cyclophosphamide as conditioning regimen.
BuCy	BuCy	Patients enrolled in this arm will receive busulfan plus cyclophosphamide as conditioning regimen.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	2 years after randomization	estimated progression-free survival at 2 year

Secondary Outcome Measures

Name	Time	Method
Overall survival	2 years after randomization	estimated overall survival at 2 year
Cumulative incidence of relapse	2 years after randomization	estimated cumulative incidence of relapse at 2 year
Non-relapse mortality	2 years after randomization	estimated non-relapse mortality at 2 year
Adverse events	2 years after randomization	Number of participants with adverse events. Frequencies of toxicities based on Common Terminology Criteria for Adverse Events (CTCAE) will be tabulated.

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China