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

Sponsor

Sheba Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03346096

Collaborator

(none)

Enrollment

Location

Arm

49.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Lymphoma	Drug: Thiotepa	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Oct 9, 2018

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Thiotepa Thiotepa for reduce toxicity and improve outcome following transplantation	Drug: Thiotepa fixed dose 5mg/kg on days -7-6

Arm

Intervention/Treatment

Experimental: Thiotepa

Thiotepa for reduce toxicity and improve outcome following transplantation

Drug: Thiotepa

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

Outcome Measures

Primary Outcome Measures

Toxicities graded by Bearman's criteria and infectious complications [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chaim Sheba Medical Center	Ramat Gan		Israel	57261

Sponsors and Collaborators

Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT03346096

Other Study ID Numbers:

Sheba - 17 - 4053 - AN - CTIL

First Posted:

Nov 17, 2017

Last Update Posted:

Oct 22, 2020

Last Verified:

Oct 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sheba Medical Center

TEAM (Thiotepa, Etoposide, Cytosar, Melphalan )

autologous stem-cell transplantation (ASCT)

malignant lymphoma

Additional relevant MeSH terms:

Lymphoma

Thiotepa

Study Results

No Results Posted as of Oct 22, 2020