NCT03346096

TEAM (Thiotepa, Etoposide, Cytosar, Melphalan ) for AutoSCT in Lymphoma

TEAM (Thiotepa, Etoposide, Cytosar, Melphalan ) in Preparation for Autologous Hematopoietic Stem-Cell Transplantation in Patients With Non-Hodgkin's and Hodgkin's Lymphoma.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Study is designed to explore whether the introduction of Thiotepa, to the pre autologous stem-cell transplantation (ASCT) conditioning will reduce toxicity and thus improve outcome following transplantation in up to 24 patients with malignant lymphoma including both non-Hodgkin's lymphoma (NHL) and Hodgkin's lymphoma ( HL) improving toxicity profile , reducing side effects while potentially improving the antitumor response. Specifically,we speculate that using the novel Thiotepa based TEAM consisted of THIOTEPA 5mg/kg on days -7-6, etoposide 200 mg/m2 , Cytosar (ARA-C) 200 mg/m2 on days -5,-4, -3, -2 and melphalan 140 mg/m2 on day -1, pre transplantation conditioning regimen may allow transplantation with lower transplant related toxicity and thus improve outcome in this setting. Toward this aim the impact on toxicity profile ,engraftment and disease control will be assessed.

Conditions

• Malignant Lymphoma

Interventions

Type	Name	Description
DRUG	Thiotepa	fixed dose 5mg/kg on days -7-6

Timeline

• Start date: 2018-10-09
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2017-11-17
• Last updated: 2024-07-09

Locations

1 site across 1 country: Israel