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

NCT02504190 | Completed

• 1 other identifier: TEAM
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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:

• 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
• Transfusion graft: the day D0 with autologous peripheral stem cell transplant
• Care supports: Patients will be treated according to the usual procedures of centers participating in the study at the discretion of the investigator.
• Follow-up of patients will not be changed by the study.
• 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

Keywords

Lymphoma; TEAM conditioning; autologous stem cells transplantation

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  1 year after autologous haematopoietic stem cells transplantation

Secondary Outcomes (6)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lymphoma patients will be recruited in on the French site

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Mohamad Mohty

Paris, 75571, France

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 21, 2015
• Study Start: July 16, 2015
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: May 20, 2020

Record last verified: 2020-05

Locations

FR (1)