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

NCT03346096 | Completed Phase 2

• 1 other identifier: Sheba - 17 - 4053 - AN - CTIL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Lymphoma

Keywords

TEAM (Thiotepa, Etoposide, Cytosar, Melphalan ); autologous stem-cell transplantation (ASCT); malignant lymphoma

Outcome Measures

Primary Outcomes (1)

• Toxicities graded by Bearman's criteria and infectious complications

  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

  15 month

Study Arms (1)

Thiotepa

EXPERIMENTAL

Thiotepa for reduce toxicity and improve outcome following transplantation

Drug: Thiotepa

Interventions

Thiotepa DRUG

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

Thiotepa

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Chaim Sheba Medical Center

Ramat Gan, 57261, Israel

Location

MeSH Terms

Conditions

Lymphoma

Interventions

Thiotepa

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramides; Organophosphorus Compounds; Organic Chemicals; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: TEAM conditioning 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 followed by autologous hematopoietic stem-cell transplantation as per standard institutional protocols.

Study Record Dates

• First Submitted: October 15, 2017
• First Posted: November 17, 2017
• Study Start: October 9, 2018
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

IL (1)