Allo-HSCT vs ASCT in Adult T-LBL

NCT06741813 | Not Yet Recruiting

• 1 other identifier: Peking University People's Hos
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

Brief Summary

Autologous hematopoietic stem cell transplantation (ASCT) is the important consolidation for adult T-LBL. Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is also the important consolidation for adult T-LBL. So ASCT vs allo-HSCT: which is better consolidation for adult T-LBL?

Conditions

T Lymphoblastic Lymphoma

Keywords

allogeneic hematopoietic stem cell transplantation; Autologous hematopoietic stem cell transplantation; T Lymphoblastic Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression-free survival (PFS), defined as the time from the date of randomization to the date of disease progression/relapse, or death due to any cause.

  Probability of PFS at months 1, 2, 6, 12, 18 & 24 will be estimated from the Kaplan-Meier curves for each arm.

Secondary Outcomes (3)

• Relapse

  Cumulative incidence of disease progression/relapse at months 1, 2, 6, 12, 18 & 24 will be estimated, considering non-relapse mortality as competing events.

• Non-relapse mortality (NRM)

  Cumulative incidence of NRM at months 1, 2, 6, 12, 18 & 24 will be estimated, considering disease progression/relapse as competing events.

• Overall survival (OS)

  Probability of overall survival at months 1, 2, 6, 12, 18 & 24 will be estimated from the Kaplan-Meier curves for each arm.

Study Arms (2)

ASCT group

ACTIVE COMPARATOR

T-LBL patients achieving CR after induction chemotherapy and then received ASCT as first line consolidation

Procedure: ASCT

Allo-HSCT

EXPERIMENTAL

T-LBL patients achieving CR after induction chemotherapy and received allo-HSCT as first line consolidation

Procedure: Allo-HSCT

Interventions

ASCT PROCEDURE

The chemotherapy-based preconditioning regimen was BeEAM, which consisted of bendamustine (120-180 mg·m-2·day-1，days -8 to -7), etoposide (200 mg·m-2·day-1，days -6 to -3), cytarabine (400 mg·m-2·day-1，days -6 to -3), and melphalan (140 mg·m-2·day-1，days -2).

ASCT group

Allo-HSCT PROCEDURE

Chemotherapy-based preconditioning regimen consisted of cytarabine 4 g·m-2·day-1 (days -9), busulfan (3.2 mg·kg-1·day-1 administered intravenously on days -8 to -6) (day 0 being the first day of donor cell infusion), cyclophosphamide (1.8 g·m-2·day-1, days -5 to -4), and semustine (250 mg.m-2, day -3). For the patients older than 55 years old or with HCT-CI score of 3 or more, cyclophosphamide can be decreased to 1.0 g·m-2·day-1, days -5 to -4, and added fludarabine (30mg·m-2·day-1, days -6 to -2). Rabbit antithymocyte globulin (thymoglobulin, 1.5 to 2.5 mg/kg, days -5 to -2; Sanofi, France) was administered to the HID and URD groups or MSD HSCT recipients who older than 40 years old (1.5 mg/kg, days -4 to -2). All MSD, HID, and URD HSCT recipinets received cyclosporine A (CsA), mycophenolate mofetil (MMF), and short-term methotrexate (MTX) for GVHD prophylaxis. CsA (2.5 mg/kg, q12h, intravenous \[i.v.\]) was used from day -9, of which the trough concentration was adjusted to 150-250 ng

Allo-HSCT

Eligibility Criteria

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

You may qualify if:

• \) Newly diagnosed T-LBL; 2) 18-65 years of age at the time of diagnosis; 3) Categorized into Ann-Arbor stage III or IV; 4) Achieving complete response (CR) after 3 courses of induction chemotherapies; 5) ECOG PS score 0 or 1; 6) It needs consent from the patients or/and legal guardian, and signature on the Informed Consent.

You may not qualify if:

• \) Newly diagnosed T-LBL, but categorized into Ann-Arbor stage I or II; 2) \< 18 years, or older than 65 years at the time of diagnosis; 3) Achieving CR after 4 or more courses of induction chemotherapies, or could not achieve at least CR after induction chemotherapies; 4) with \> 25% BM involvement or \> 5% lymphoma cells in the peripheral blood; 5) ECOG PS score of 2 or more; 6) Patients with other comorbidities or mental diseases that influence the life safety and compliance of patients as well as affect informed consent, enrollment in the research, follow-up visit or result interpretation.

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Xiao-Dong Mo None

CONTACT

13810096698; moxiaodong@pkuph.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: For the adult patients (≥ 18 years) with Ann-Arbor stage III or IV T-LBL and achieving CR after 3 courses of induction chemotherapy, all the patients who fulfilled inclusion/exclusion criteria were randomly assigned in a 1:1 ratio to receive ASCT (ASCT group) or receive allo-HSCT (Allo-HSCT group). Patients would receive additional 1 course of chemotherapy after randomization and then received HSCT. Then we compared the clinical outcomes between the two groups.

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 19, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share