Status:
COMPLETED
TEAM (Thiotepa, Etoposide, Cytosar, Melphalan ) for AutoSCT in Lymphoma
Lead Sponsor:
Sheba Medical Center
Conditions:
Malignant Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 transplan...
Eligibility Criteria
Inclusion
- Patients with non-Hodgkin's and Hodgkin's lymphoma as confirmed by a pathological biopsy report.
- Patients who are candidates for Autologous stem-cell transplantation due to refractory or relapsing disease by standard institutional indications and comply with standard transplant eligibility criteria.
- Age less than physiologic 70 years.
- Patients with an adequate autologous stem cell collection for transplantation and backup (\>5 x 106 CD34(cluster of differentiation 34)+ cells/kg) .Patients must sign written informed consent.
- No limitation on bulky disease or bone marrow involvement. No limitation on the number and response to prior therapy. Prior autologous transplantation and/or treatment with rituximab allowed. All prior chemotherapy completed at least three weeks before study treatment
Exclusion
- Bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit
- Creatinine \> 2.0 mg/dl
- Eastern Cooperative Oncology Group (ECOG) Performance status \> 2
- Uncontrolled infection
- Pregnancy or lactation
- Abnormal lung diffusion capacity (DLCO \< 40% predicted)
- Severe cardiovascular disease
- CNS (central nervous system) disease involvement
- Pleural effusion or ascites \> 1 liter
- Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
Key Trial Info
Start Date :
October 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03346096
Start Date
October 9 2018
End Date
June 30 2024
Last Update
July 9 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chaim Sheba Medical Center
Ramat Gan, Israel, 57261