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

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.

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Key information

Conditions

Malignant Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chaim Sheba Medical Center

Ramat Gan, 57261, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thiotepa

Drug

fixed dose 5mg/kg on days -7-6

Primary outcomes

Toxicities graded by Bearman's criteria and infectious complications

Time frame: 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

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

TEAM (Thiotepa, Etoposide, Cytosar, Melphalan ) in Preparation for Autologous Hematopoietic Stem-Cell Transplantation in Patients With Non-Hodgkin's and Hodgkin's Lymphoma.

Acronym: TEAM

Important dates

Study start: 2018
Primary completion: 2024
Study completion: 2024
First posted: Nov 17, 2017
Registry last updated: Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed