Clinical trial NCT02504190: Non-interventional Study on TEAM Conditioning in Patients With Lymphoma (TEAM)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: Lymphoma
TEAM conditioning
autologous stem cells transplantation
Lead sponsor: Association for Training, Education, and Research in Hematology, Immunology, and Transplantation
Sponsor class: OTHER
First posted: 2015-07-21
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lymphoma patients will be recruited in on the French site

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).


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

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 1 year after autologous haematopoietic stem cells transplantation
Secondary outcomes:
measure: Overall Survival
timeFrame: 100 days and at 1 year after autologous haematopoietic stem cells transplantation
measure: Overall and complete response rate
timeFrame: 100 days and 1 year after autologous haematopoietic stem cells transplantation
measure: Incidence of relapse
timeFrame: 100 days and 1 year after autologous haematopoietic stem cells transplantation
measure: Impact of transplant-related mortality
timeFrame: 100 days and 1 year after autologous haematopoietic stem cells transplantation
measure: Incidence of infections
timeFrame: during aplasia, 100 days and 1 year after autologous haematopoietic stem cells transplantation
measure: Incidence of grade 3-4 side effects
timeFrame: during aplasia, 100 days and 1 year after autologous haematopoietic stem cells transplantation
Other outcomes:
Locations:
city: Paris
country: France
facility: Mohamad Mohty
Study officials:
References: