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

Non-interventional Study Evaluating Efficacy and Tolerance on TEAM Conditioning (Thiotepa/Etoposide/Aracytin/Melphalan) Followed by Autologous Haematopoietic Stem Cells Transplantation in Patients With Lymphoma

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).

Study Overview

• Status: Completed
• Conditions: Lymphoma

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• France
  • Paris, France, 75571
    • Mohamad Mohty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Lymphoma patients will be recruited in on the French site

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival (PFS)	1 year after autologous haematopoietic stem cells transplantation

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	100 days and at 1 year after autologous haematopoietic stem cells transplantation
Overall and complete response rate	100 days and 1 year after autologous haematopoietic stem cells transplantation
Incidence of relapse	100 days and 1 year after autologous haematopoietic stem cells transplantation
Impact of transplant-related mortality	100 days and 1 year after autologous haematopoietic stem cells transplantation
Incidence of infections	during aplasia, 100 days and 1 year after autologous haematopoietic stem cells transplantation
Incidence of grade 3-4 side effects	during aplasia, 100 days and 1 year after autologous haematopoietic stem cells transplantation

Collaborators and Investigators

• Sponsor: Association for Training, Education, and Research in Hematology, Immunology, and Transplantation

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2015
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: July 20, 2015
• First Submitted That Met QC Criteria: July 20, 2015
• First Posted (Estimate): July 21, 2015

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Lymphoma; TEAM conditioning; autologous stem cells transplantation
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: TEAM