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

Sheba Medical Center

Status and phase: Completed; Phase 2

Conditions: Malignant Lymphoma

Treatments: Drug: Thiotepa

Study type: Interventional

Funder types: Other

Identifiers

NCT03346096

Sheba - 17 - 4053 - AN - CTIL

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with non-Hodgkin's and Hodgkin's lymphoma as confirmed by a pathological biopsy report.
2. 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.
3. Age less than physiologic 70 years.
4. 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.
5. 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

1. Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit
2. Creatinine > 2.0 mg/dl
3. Eastern Cooperative Oncology Group (ECOG) Performance status > 2
4. Uncontrolled infection
5. Pregnancy or lactation
6. Abnormal lung diffusion capacity (DLCO < 40% predicted)
7. Severe cardiovascular disease
8. CNS (central nervous system) disease involvement
9. Pleural effusion or ascites > 1 liter
10. Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Thiotepa

Experimental group

Description:

Thiotepa for reduce toxicity and improve outcome following transplantation

Treatment:

Drug: Thiotepa