NCT04861207

Total Body Irradiation and Cladribine Before Allogeneic Hematopoietic Cell Transplantation in Patients With AML (Acute Myeloid Leukemia) and Myelodysplastic Syndromes

Assessment of Tolerance and Effectiveness of Total Body Irradiation and Cladribine Before Allogeneic Hematopoietic Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A single center, prospective, one arm clinical study to assess the tolerance and effectiveness of total body irradiation and cladribine in adult patients diagnosed with AML( acute myeloid leukemia) and myelodysplastic syndromes.

Conditions

• Acute Myeloid Leukemia Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Cladribine	The conditioning regimen used will be cladribine-based at a dose of 5 mg / m2 for 5 days (iv.) and total body irradiation at a total dose of 12 Gy in three fractions.

Timeline

• Start date: 2021-10-07
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2021-04-27
• Last updated: 2025-04-24

Locations

1 site across 1 country: Poland