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

Last updated: July 8, 2024
Sponsor: Sheba Medical Center
Overall Status: Completed

Phase

2

Condition

Lymphoma

Treatment

Thiotepa

Clinical Study ID

NCT03346096
Sheba - 17 - 4053 - AN - CTIL
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with non-Hodgkin's and Hodgkin's lymphoma as confirmed by a pathologicalbiopsy report.

  2. Patients who are candidates for Autologous stem-cell transplantation due torefractory or relapsing disease by standard institutional indications and complywith standard transplant eligibility criteria.

  3. Age less than physiologic 70 years.

  4. Patients with an adequate autologous stem cell collection for transplantation andbackup (>5 x 106 CD34(cluster of differentiation 34)+ cells/kg) .Patients must signwritten informed consent.

  5. No limitation on bulky disease or bone marrow involvement. No limitation on thenumber and response to prior therapy. Prior autologous transplantation and/ortreatment with rituximab allowed. All prior chemotherapy completed at least threeweeks before study treatment

Exclusion

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 orto adequately co-operate

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Thiotepa
Phase: 2
Study Start date:
October 09, 2018
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • Chaim Sheba Medical Center

    Ramat Gan, 57261
    Israel

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.