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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-09

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Malignant Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Thiotepa

Thiotepa for reduce toxicity and improve outcome following transplantation

Group Type EXPERIMENTAL

Thiotepa

Intervention Type DRUG

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

Interventions

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Thiotepa

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No