Non-interventional Study on TEAM Conditioning in Patients With Lymphoma (TEAM)

NCT ID: NCT02504190

Last Updated: 2020-05-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 95 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-16
• Study Completion Date: 2019-11-30

Brief Summary

Lymphoma is a malignant blood disease sensitive to chemotherapy. In case of relapse after first-line treatment, high-dose chemotherapy conditioning followed by autologous hematopoietic stem cell transplantation (auto-HSCT) improves patient survival and reduces the risk of relapse. Auto-HSCT may also be indicated in the first line in case of aggressive lymphoma at high risk of relapse. BEAM (Carmustine, Etoposide, Aracytine and Melphalan) is the more frequently used high-dose conditioning regimen. Nevertheless, Carmustine is no longer available in Europe.

The investigators have therefore chosen to replace Carmustine by Thiotepa and use the TEAM regimen as the new conditioning. Indeed, Thiotepa is approved by french national agency for the security of drugs (ANSM) for use as part of auto-HSCT conditioning regimen. The results of TEAM regimen in terms of efficacy and toxicity appear similar to those of BEAM. However, no study have been performed prospectively. Only small series and case reports have been reported.

If the study confirms the results of retrospective studies, conditioning by TEAM could become a new standard in auto-HSCT for the treatment of lymphoma.

This study is non-interventional, prospective with 3 centers.

All included patients will receive, according to standard practice and drug label in France, the following diagram:

1. Conditioning:

• Thiotepa 8 mg / kg to J-6
• Etoposide 100 mg / m² / 12 h for 4 days (J-5 to D-2)
• Aracytine 200 mg / m² / 12 h for 4 days (J-5 to D-2)
• Melphalan 140 mg / m² on day-1

2. Transfusion graft: the day D0 with autologous peripheral stem cell transplant

3. Care supports: Patients will be treated according to the usual procedures of centers participating in the study at the discretion of the investigator.

4. Follow-up of patients will not be changed by the study.

The main objective of the study is to evaluate the progression-free survival (PFS) of lymphoma patients treated with autologous stem cells after conditioning by TEAM

Secondary objectives are:

• To evaluate overall survival;
• To assess the response to treatment;
• to evaluate the incidence of relapse;
• to assess the toxic transplant related mortality;
• to study transplant-related morbidity (infections, nutritional and gastrointestinal toxicity, immune reconstitution).

Conditions

Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

lymphoma patients eligible for TEAM conditioning

Lymphoma Patients who are eligible will be included. Patients will undergo TEAM conditioning regimen followed by autologous haematopoietic stem cells transplantation according to standard practice of the centre and drugs label in France.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients aged between 18 and 65 years,
• lymphoma confirmed by biopsy
• first autologous haematopoietic stem cells transplantation after TEAM conditioning

Exclusion Criteria

• VIH, HBV, and/or HCV seropositive
• Contraindication to autologous stem cell transplantation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Association for Training, Education, and Research in Hematology, Immunology, and Transplantation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mohamad Mohty

Paris, , France

Countries

France

Other Identifiers

TEAM

Identifier Type: -

Identifier Source: org_study_id