TEAM (Thiotepa Etoposide Cytosar Melphalan ) for AutoSCT in Lymphoma

  • STATUS
    Recruiting
  • End date
    Dec 25, 2022
  • participants needed
    50
  • sponsor
    Sheba Medical Center
Updated on 25 January 2021
hodgkin's disease
melphalan
cell transplantation
thiotepa
etoposide

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.

Details
Condition Lymphoma, Lymphoma, Non-Hodgkin's Lymphoma, lymphomas
Treatment thiotepa
Clinical Study IdentifierNCT03346096
SponsorSheba Medical Center
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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