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

Phase 2

Completed

• Conditions: Malignant Lymphoma
• Interventions: Drug: Thiotepa

• Registration Number: NCT03346096
• Lead Sponsor: Sheba Medical Center

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-15
• Study First Submitted QC: 2017-11-14
• Study First Posted: 2017-11-17
• Study Start: 2018-10-09
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thiotepa	Thiotepa	Thiotepa for reduce toxicity and improve outcome following transplantation

Primary Outcome Measures

Name	Time	Method
Toxicities graded by Bearman's criteria and infectious complications	15 month	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

Trial Locations

Locations (1)

Chaim Sheba Medical Center; 🇮🇱 Ramat Gan, Israel