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CompletedNCT03346096TEAMUpdated Jul 9, 2024

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

A Phase 2 interventional study of Thiotepa in Malignant Lymphoma, sponsored by Sheba Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-09.

Sponsored by Sheba Medical Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

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.

02

Conditions studied

  • Malignant Lymphoma

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Keywords

  • TEAM (Thiotepa, Etoposide, Cytosar, Melphalan )
  • autologous stem-cell transplantation (ASCT)
  • malignant lymphoma
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Thiotepa

    Thiotepa for reduce toxicity and improve outcome following transplantation

    Drug: Thiotepa

Interventions

  • DrugThiotepa

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

05

What researchers measure

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

    Time frame: 15 month

06

Study locations

1 site
  • Chaim Sheba Medical Center
    Ramat Gan, 57261, Israel
07

Registry details

Key details

Study ID
NCT03346096
Lead sponsor
Sheba Medical Center
Responsible party
Sponsor
First posted
Nov 17, 2017
Start date
Oct 9, 2018
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024
Last update
Jul 9, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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