NCT00682305

Allogeneic Stem Cell Transplantation (SCT) With Treosulfan, VP-16 and Cyclophosphamid for Patients With Acute Lymphoblastic Leukemia (ALL)

Allogeneic Stem Cell Transplantation With Treosulfan, VP-16 and Cyclophosphamide for Patients With Acute Lymphoblastic Leukemia (ALL) Not Eligible for TBI-containing Conditioning Regimen: A Phase II-study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The present study is a multicenter, prospective phase II-study investigating the combination of treosulfan, etoposide, and cyclophosphamide as conditioning regimen for patients with acute lymphoblastic leukemia who are not eligible for a TBI-containing regimen.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
PROCEDURE	Hematopoietic stem cell transplantation	conditioning regimen: * day -7: 12g/m\^2 Treosulfan * day -6: 12g/m\^2 Treosulfan * day -5: 12g/m\^2 Treosulfan * day -4: 30mg/kg BW Etoposide * day -3: 20mg/kg ATG Fresenius (OPTIONAL), 60mg/kg BW Cyclophosphamide * day -2: 20mg/kg ATG Fresenius (OPTIONAL), 60mg/kg BW Cyclophosphamide * day -1: 20mg/kg ATG Fresenius (OPTIONAL) * day 0: SCT

Timeline

• Start date: 2007-03-01
• Primary completion: 2013-01-01
• Completion: 2013-08-01
• First posted: 2008-05-22
• Last updated: 2015-05-13

Locations

1 site across 1 country: Germany