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NCT Number: NCT02504190

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

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mohamad Mohty

Paris, 75571, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: 1 year after autologous haematopoietic stem cells transplantation

Secondary outcomes

  1. Overall Survival

    Time frame: 100 days and at 1 year after autologous haematopoietic stem cells transplantation

  2. Overall and complete response rate

    Time frame: 100 days and 1 year after autologous haematopoietic stem cells transplantation

  3. Incidence of relapse

    Time frame: 100 days and 1 year after autologous haematopoietic stem cells transplantation

  4. Impact of transplant-related mortality

    Time frame: 100 days and 1 year after autologous haematopoietic stem cells transplantation

  5. Incidence of infections

    Time frame: during aplasia, 100 days and 1 year after autologous haematopoietic stem cells transplantation

  6. Incidence of grade 3-4 side effects

    Time frame: during aplasia, 100 days and 1 year after autologous haematopoietic stem cells transplantation

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Acronym: TEAM

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 21, 2015
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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