LymphomaTEAMNCT02504190
Non-interventional Study on TEAM Conditioning in Patients With Lymphoma (TEAM)
An observational study of Lymphoma, run by Association for Training, Education, and Research in Hematology, Immunology, and Transplantation at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphoma
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jul 2015to 30 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lymphoma patients will be recruited in on the French site
Who may be able to join
- Patients aged between 18 and 65 years,
- lymphoma confirmed by biopsy
- first autologous haematopoietic stem cells transplantation after TEAM conditioning
Who cannot join
- VIH, HBV, and/or HCV seropositive
- Contraindication to autologous stem cell transplantation
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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:
- 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
- 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.
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).
- Conditions
- Lymphoma
- Keywords
- Lymphoma, TEAM conditioning, autologous stem cells transplantation
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Measured: 1 year after autologous haematopoietic stem cells transplantation
Secondary outcomes (6)
Overall Survival
Measured: 100 days and at 1 year after autologous haematopoietic stem cells transplantation
Overall and complete response rate
Measured: 100 days and 1 year after autologous haematopoietic stem cells transplantation
Incidence of relapse
Measured: 100 days and 1 year after autologous haematopoietic stem cells transplantation
Impact of transplant-related mortality
Measured: 100 days and 1 year after autologous haematopoietic stem cells transplantation
Incidence of infections
Measured: during aplasia, 100 days and 1 year after autologous haematopoietic stem cells transplantation
Incidence of grade 3-4 side effects
Measured: during aplasia, 100 days and 1 year after autologous haematopoietic stem cells transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study start16 Jul 2015
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association for Training, Education, and Research in Hematology, Immunology, and Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504190
- Sponsor's protocol ID
- TEAM
- Acronym
- TEAM
- Status last verified
- May 2020
- First submitted
- 20 Jul 2015
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study 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
- ClinicalTrials.gov ID
- NCT02504190
- Acronym / sponsor ID
- TEAM / TEAM
- Conditions
- Lymphoma
- Keywords
- Lymphoma, TEAM conditioning, autologous stem cells transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Association for Training, Education, and Research in Hematology, Immunology, and TransplantationUniversity, hospital or other
- Study start
- 16 Jul 2015 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lymphoma patients will be recruited in on the French site
Key inclusion criteria (3 listed)
- Patients aged between 18 and 65 years,
- lymphoma confirmed by biopsy
- first autologous haematopoietic stem cells transplantation after TEAM conditioning
Key exclusion criteria (2 listed)
- VIH, HBV, and/or HCV seropositive
- Contraindication to autologous stem cell transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression free survival (PFS)
Time frame: 1 year after autologous haematopoietic stem cells transplantation
6 secondary outcomes
Overall Survival
Time frame: 100 days and at 1 year after autologous haematopoietic stem cells transplantation
Overall and complete response rate
Time frame: 100 days and 1 year after autologous haematopoietic stem cells transplantation
Incidence of relapse
Time frame: 100 days and 1 year after autologous haematopoietic stem cells transplantation
Impact of transplant-related mortality
Time frame: 100 days and 1 year after autologous haematopoietic stem cells transplantation
Incidence of infections
Time frame: during aplasia, 100 days and 1 year after autologous haematopoietic stem cells transplantation
Incidence of grade 3-4 side effects
Time frame: during aplasia, 100 days and 1 year after autologous haematopoietic stem cells transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
Related trials for Lymphoma
RecruitingPhase 2/3
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
B-cell Acute Lymphoblastic Leukemia
Active, not recruitingPhase 1/2
Tafasitamab, Retifanlimab, and Rituximab in Combination With Standard Therapy for the Treatment of Diffuse Large B-cell Lymphoma
Diffuse Large B-Cell Lymphoma, Grade 3b Follicular Lymphoma
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
RecruitingPhase 1
225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Recruiting
More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
Acute Lymphatic Leukemia, Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, run by Association for Training, Education, and Research in Hematology, Immunology, and Transplantation at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: 1 year after autologous haematopoietic stem cells transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.