Malignant LymphomaPhase 2TEAMNCT03346096
TEAM (Thiotepa, Etoposide, Cytosar, Melphalan ) for AutoSCT in Lymphoma
A Phase 2 study testing Thiotepa in people with Malignant Lymphoma, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Study is designed to explore whether the introduction of Thiotepa, to the pre autologous stem-cell transplantation (ASCT) conditioning will reduce toxicity and thus improve outcome following transplantation in up to 24 patients with malignant lymphoma including both non-Hodgkin's lymphoma (NHL) and Hodgkin's lymphoma… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignant Lymphoma
- What is being tested?
- Thiotepa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Oct 2018to 30 Jun 2024
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with non-Hodgkin's and Hodgkin's lymphoma as confirmed by a pathological biopsy report.
- Patients who are candidates for Autologous stem-cell transplantation due to refractory or relapsing disease by standard institutional indications and comply with standard transplant eligibility criteria.
- Age less than physiologic 70 years.
- Patients with an adequate autologous stem cell collection for transplantation and backup (>5 x 106 CD34(cluster of differentiation 34)+ cells/kg) .Patients must sign written informed consent.
- No limitation on bulky disease or bone marrow involvement. No limitation on the number and response to prior therapy. Prior autologous transplantation and/or treatment with rituximab allowed. All prior chemotherapy completed at least three weeks before study treatment
Who cannot join
- Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit
- Creatinine > 2.0 mg/dl
- Eastern Cooperative Oncology Group (ECOG) Performance status > 2
- Uncontrolled infection
- Pregnancy or lactation
- Abnormal lung diffusion capacity (DLCO < 40% predicted)
Show all 10Show fewer
- Severe cardiovascular disease
- CNS (central nervous system) disease involvement
- Pleural effusion or ascites > 1 liter
- Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TEAM (Thiotepa, Etoposide, Cytosar, Melphalan ) in Preparation for Autologous Hematopoietic Stem-Cell Transplantation in Patients With Non-Hodgkin's and Hodgkin's Lymphoma.
Study is designed to explore whether the introduction of Thiotepa, to the pre autologous stem-cell transplantation (ASCT) conditioning will reduce toxicity and thus improve outcome following transplantation in up to 24 patients with malignant lymphoma including both non-Hodgkin's lymphoma (NHL) and Hodgkin's lymphoma ( HL) improving toxicity profile , reducing side effects while potentially improving the antitumor response. Specifically,we speculate that using the novel Thiotepa based TEAM consisted of THIOTEPA 5mg/kg on days -7-6, etoposide 200 mg/m2 , Cytosar (ARA-C) 200 mg/m2 on days -5,-4, -3, -2 and melphalan 140 mg/m2 on day -1, pre transplantation conditioning regimen may allow transplantation with lower transplant related toxicity and thus improve outcome in this setting. Toward this aim the impact on toxicity profile ,engraftment and disease control will be assessed.
- Conditions
- Malignant Lymphoma
- Being tested
- Thiotepa
- Keywords
- TEAM (Thiotepa, Etoposide, Cytosar, Melphalan ), autologous stem-cell transplantation (ASCT), malignant lymphoma
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThiotepaDrug
fixed dose 5mg/kg on days -7-6
| Study group | Role | What they receive |
|---|---|---|
| Thiotepa | Experimental | Thiotepa for reduce toxicity and improve outcome following transplantation Receives: Drug: Thiotepa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicities graded by Bearman's criteria and infectious complications
To determine the relative toxicity and response rate of TEAM preparative regimen pre- Autologous stem cell transplantation in patients with non-Hodgkin's and Hodgkin's Lymphoma
Measured: 15 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start9 Oct 2018
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant LymphomaStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- TEAM conditioning consisted of THIOTEPA 5mg/kg on days -7-6, etoposide 200 mg/m2 , Cytosar (ARA-C) 200 mg/m2 on days -5,-4, -3, -2 and melphalan 140 mg/m2 on day -1 followed by autologous hematopoietic stem-cell transplantation as per standard institutional protocols.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346096
- Sponsor's protocol ID
- Sheba - 17 - 4053 - AN - CTIL
- Acronym
- TEAM
- Status last verified
- Jul 2024
- First submitted
- 15 Oct 2017
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEAM (Thiotepa, Etoposide, Cytosar, Melphalan ) in Preparation for Autologous Hematopoietic Stem-Cell Transplantation in Patients With Non-Hodgkin's and Hodgkin's Lymphoma.
- ClinicalTrials.gov ID
- NCT03346096
- Acronym / sponsor ID
- TEAM / Sheba - 17 - 4053 - AN - CTIL
- Conditions
- Malignant Lymphoma
- Keywords
- TEAM (Thiotepa, Etoposide, Cytosar, Melphalan ), autologous stem-cell transplantation (ASCT), malignant lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 17 Nov 2017 (actual)
- 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.
Study is designed to explore whether the introduction of Thiotepa, to the pre autologous stem-cell transplantation (ASCT) conditioning will reduce toxicity and thus improve outcome following transplantation in up to 24 patients with malignant lymphoma including both non-Hodgkin's lymphoma (NHL) and Hodgkin's lymphoma ( HL) improving toxicity profile , reducing side effects while potentially improving the antitumor response. Specifically,we speculate that using the novel Thiotepa based TEAM consisted of THIOTEPA 5mg/kg on days -7-6, etoposide 200 mg/m2 , Cytosar (ARA-C) 200 mg/m2 on days -5,-4, -3, -2 and melphalan 140 mg/m2 on day -1, pre transplantation conditioning regimen may allow transplantation with lower transplant related toxicity and thus improve outcome in this setting. Toward this aim the impact on toxicity profile ,engraftment and disease control will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- TEAM conditioning consisted of THIOTEPA 5mg/kg on days -7-6, etoposide 200 mg/m2 , Cytosar (ARA-C) 200 mg/m2 on days -5,-4, -3, -2 and melphalan 140 mg/m2 on day -1 followed by autologous hematopoietic stem-cell transplantation as per standard institutional protocols.
| Arm | Type | Receives |
|---|---|---|
| Thiotepa | Experimental | Drug: ThiotepaThiotepa for reduce toxicity and improve outcome following transplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with non-Hodgkin's and Hodgkin's lymphoma as confirmed by a pathological biopsy report.
- Patients who are candidates for Autologous stem-cell transplantation due to refractory or relapsing disease by standard institutional indications and comply with standard transplant eligibility criteria.
- Age less than physiologic 70 years.
- Patients with an adequate autologous stem cell collection for transplantation and backup (>5 x 106 CD34(cluster of differentiation 34)+ cells/kg) .Patients must sign written informed consent.
- No limitation on bulky disease or bone marrow involvement. No limitation on the number and response to prior therapy. Prior autologous transplantation and/or treatment with rituximab allowed. All prior chemotherapy completed at least three weeks before study treatment
Key exclusion criteria (10 listed)
- Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit
- Creatinine > 2.0 mg/dl
- Eastern Cooperative Oncology Group (ECOG) Performance status > 2
- Uncontrolled infection
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thiotepafixed dose 5mg/kg on days -7-6 | Drug | Thiotepa |
Primary outcome
Toxicities graded by Bearman's criteria and infectious complications
Time frame: 15 month
To determine the relative toxicity and response rate of TEAM preparative regimen pre- Autologous stem cell transplantation in patients with non-Hodgkin's and Hodgkin's Lymphoma
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 9 Jul 2024.
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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?
A Phase 2 study testing Thiotepa in people with Malignant Lymphoma, run by Sheba Medical Center at 1 site in Israel.
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 5 inclusion and 10 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 9 Jul 2024. 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 Israel. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Toxicities graded by Bearman's criteria and infectious complications (time frame: 15 month). 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 9 Jul 2024.