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

Primary Purpose

Malignant Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Thiotepa
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Lymphoma focused on measuring TEAM (Thiotepa, Etoposide, Cytosar, Melphalan ), autologous stem-cell transplantation (ASCT), malignant lymphoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chaim Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Thiotepa

Arm Description

Thiotepa for reduce toxicity and improve outcome following transplantation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 15, 2017
Last Updated
October 21, 2020
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03346096
Brief Title
TEAM (Thiotepa, Etoposide, Cytosar, Melphalan ) for AutoSCT in Lymphoma
Acronym
TEAM
Official Title
TEAM (Thiotepa, Etoposide, Cytosar, Melphalan ) in Preparation for Autologous Hematopoietic Stem-Cell Transplantation in Patients With Non-Hodgkin's and Hodgkin's Lymphoma.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 9, 2018 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Lymphoma
Keywords
TEAM (Thiotepa, Etoposide, Cytosar, Melphalan ), autologous stem-cell transplantation (ASCT), malignant lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thiotepa
Arm Type
Experimental
Arm Description
Thiotepa for reduce toxicity and improve outcome following transplantation
Intervention Type
Drug
Intervention Name(s)
Thiotepa
Intervention Description
fixed dose 5mg/kg on days -7-6
Primary Outcome Measure Information:
Title
Toxicities graded by Bearman's criteria and infectious complications
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnon Nagler, MD
Phone
972-3-530 5830
Email
a.nagler@sheba.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Avichai Shimoni, MD
Phone
972-3-530 5830
Email
ashimoni@sheba.health.gov.il
Facility Information:
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
57261
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnon Nagler, M.D.
First Name & Middle Initial & Last Name & Degree
M.D.

12. IPD Sharing Statement

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

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