A Phase 2 interventional study of Thiotepa in Malignant Lymphoma, sponsored by Sheba Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by Sheba Medical Center · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
Thiotepa for reduce toxicity and improve outcome following transplantation
Drug: Thiotepa
fixed dose 5mg/kg on days -7-6
Toxicities graded by Bearman's criteria and infectious complications
To determine the relative toxicity and response rate of TEAM preparative regimen pre- Autologous stem cell transplantation in patients with non-Hodgkin's and Hodgkin's Lymphoma
Time frame: 15 month
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Sheba Medical Center