NCT01991457

Fludarabine / Total Body Irradiation Regimen for ALLO HCT in Acute Lymphoblastic Leukemia

Single Arm Phase II Study of Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Acute Lymphoblastic Leukemia (ALL) in Older Patients Using Fludarabine and Total Body Irradiation (FluTBI) Regimen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this research is to test if the conditioning regimen, fludarabine and total body irradiation (FluTBI), can lead to a safer and more effective stem cell transplant treatment regimen for ALL patients older than 40 years of age and/or younger patients with high risk medical conditions. The primary objective is to establish the efficacy of allo HCT in older ALL patients using myeloablative FluTBI conditioning regimen. The investigators are also assessing the safety and toxicity of allo HCT in older ALL patients using myeloablative FluTBI conditioning regimen.

Conditions

• Adult Lymphoblastic Lymphoma

Interventions

Type	Name	Description
DRUG	Fludarabine
PROCEDURE	Total Body Irradiation

Timeline

• Start date: 2013-08-27
• Primary completion: 2020-01-30
• Completion: 2022-08-23
• First posted: 2013-11-25
• Last updated: 2024-01-12
• Results posted: 2022-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study