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

• Sponsor: Association for Training, Education, and Research in Hematology, Immunology, and Transplantation (Other)
• Overall Status: Completed
• CT.gov ID: NCT02504190
• Collaborator: (none)
• Enrollment: 95
• Location: 1
• Actual Duration (Months): 52.5
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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

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

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

3. 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).

Condition or Disease	Intervention/Treatment	Phase
Lymphoma

Study Design

• Study Type: Observational
• Actual Enrollment: 95 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Jul 16, 2015
• Actual Primary Completion Date: Nov 30, 2019
• Actual Study Completion Date: Nov 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Progression free survival (PFS) [1 year after autologous haematopoietic stem cells transplantation]

Secondary Outcome Measures

1. Overall Survival [100 days and at 1 year after autologous haematopoietic stem cells transplantation]

2. Overall and complete response rate [100 days and 1 year after autologous haematopoietic stem cells transplantation]

3. Incidence of relapse [100 days and 1 year after autologous haematopoietic stem cells transplantation]

4. Impact of transplant-related mortality [100 days and 1 year after autologous haematopoietic stem cells transplantation]

5. Incidence of infections [during aplasia, 100 days and 1 year after autologous haematopoietic stem cells transplantation]

6. Incidence of grade 3-4 side effects [during aplasia, 100 days and 1 year after autologous haematopoietic stem cells transplantation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mohamad Mohty	Paris		France	75571

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Association for Training, Education, and Research in Hematology, Immunology, and Transplantation
• ClinicalTrials.gov Identifier: NCT02504190
• Other Study ID Numbers: TEAM
• First Posted: Jul 21, 2015
• Last Update Posted: May 20, 2020
• Last Verified: May 1, 2020

• Keywords provided by Association for Training, Education, and Research in Hematology, Immunology, and Transplantation: Lymphoma; TEAM conditioning; autologous stem cells transplantation
• Additional relevant MeSH terms: Lymphoma

Study Results

No Results Posted as of May 20, 2020