Lymphoblastic LymphomaNCT00882011
Observational Controlled Clinical Trials, on Adult Patients With T-lymphoblastic Lymphoma Treated With Intensive Chemo/Radiotherapy or Intensive Chemotherapy Followed by Transplant. Evaluation of Clinical, Anatomy -Pathological Parameters
An observational study of Lymphoblastic Lymphoma, run by Fondazione Italiana Linfomi - ETS at 17 sites in Italy.
Trial summary
The purpose of the study is to create a prospective database of T-Lymphoblastic Lymphoma (T-LBL) cases in order to conduct an appropriate statistical study as well as to monitor diagnosis and minimal residual disease (MRD), to detect specific genetic profile useful to give advices on therapies, to assess if PET has a… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Lymphoblastic Lymphoma
- What is being tested?
- Latest generation chemotherapies for T-LBL + transplant
- How many people
- 100 participants
- Where
- 17 sitesItaly
- Study dates
- Apr 2009to Apr 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients with T-lymphoblastic lymphoma treated with intensive chemo/radiotherapy or intensive chemotherapy followed by transplant.
Who may be able to join
- no previous therapy, except for treatments to face up to clinical presentation of emergency;
- medical history initially characterized by nodal mass/masses;
- histological and immunophenotypic diagnosis that documents the diagnosis of T-LBL; in cases of bone marrow involvement and difficulties in obtaining nodal material, diagnosis could be based on bone marrow;
- availability of biological material for the study of TCR and gene-profile;
- age ≥ 15 years;
- all stages;
Show all 10Show fewer
- infiltrated bone marrow <25%;
- normal liver, renal and cardiac functions, except for alterations directly related to lymphoma;
- estimates of treatment according to one of the last generation schedules;
- written informed consent.
Who cannot join
- patients with previous HCV, HBsAg+ or suffering from HIV;
- patients with organic pathology not related to lymphoma.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Italy17 sites, 17 recruiting
- Not yet recruiting
Casa Sollievo della Sofferenza
Foggia
Nicola Cascavilla, MD
- Recruiting
Ospedale San Martino
Genova
Michele Carella, MD
- Not yet recruiting
Ospedale Vito Fazzi
Lecce
Nicola Di Renzo, MD
- Recruiting
Azienda Ospedaliera Papardo
Messina
Maura Brugiatelli, MD
- Not yet recruiting
Ospedale dell'Angelo
Mestre, VE
Teodoro Chisesi, MD
- Recruiting
Università degli studi di Modena
Modena
Massimo Federico, MD
- Recruiting
Policlinico San Matteo
Pavia
Ercole Brusamolino
- Recruiting
Ospedale Civile Santo Spirito
Pescara
Simona Falorio, MD
- Not yet recruiting
Ospedale San Carlo
Potenza
Attilio Olivieri, MD
- Not yet recruiting
Ospedale Bianche Melacrino Morelli
Reggio Calabria
Caterina Stelitano, MD
- Recruiting
Ospedale Sant'Eugenio
Roma
Elisabetta Abruzzese, MD
- Recruiting
Università La Sapienza
Roma
Maurizio Martelli, MD
- Recruiting
Azienda Ospedaliera Sassari
Sassari
Maurizio Longinotti, MD
- Not yet recruiting
Ospedale San Giovanni Battista Molinette
Torino
Umberto Vitolo, MD
- Recruiting
Ospedale San Giovanni Battista Molinette
Torino
Umberto Vitolo, MD
- Not yet recruiting
San Giovanni Battista Molinette - Biologia Molecolare
Torino
Marco Ladetto, MD
- Not yet recruiting
Policlinico GB Rossi
Verona
Giovanni Pizzolo, PhD
About this study
Official title: Observational Controlled Clinical Trials, on Adult Patients With T-lymphoblastic Lymphoma Treated With Intensive Chemo/Radiotherapy or Intensive Chemotherapy Followed by Transplant. Evaluation of Clinical, Anatomy-pathological Parameters
The purpose of the study is to create a prospective database of T-Lymphoblastic Lymphoma (T-LBL) cases in order to conduct an appropriate statistical study as well as to monitor diagnosis and minimal residual disease (MRD), to detect specific genetic profile useful to give advices on therapies, to assess if PET has a prognostic validity on T-Lymphoblastic Lymphoma (T-LBL).
Read the detailed description
Observational prospective Clinical Trial designed to:
- record all patients treated with a latest generation ALL-like therapy (e.g.: Holzer, LSA2-L2 modified, GIMEMA LAL094), an enhanced therapy (hyper-CVAD or Stanford), autologous or allogeneic transplant or reduced intensity conditioning allotransplant after induction/consolidation and also expected cases treated with high dose sequential therapy or intensified minimal residual disease (MRD) oriented therapy;
- enter classic T-LBL patients (bone marrow infiltrate <25%) treated as long as previous section;
- monitor therapy response/phenotype ratio by the study of phenotype;
- monitor therapy response/residual disease/patients outcome ratio by the study of T-cell receptor gene rearrangement;
- evaluate any gene-profile difference between T-LBL pre-thymic phenotype and T-LBL thymic phenotype so as to correlate it to outcome;
- monitor the stage of the disease at diagnosis, during the therapy and during the follow-up by means of TAC, so to value if PET (in association with TAC) is an additional and/or outcome predicting element compared to TAC.
- Conditions
- Lymphoblastic Lymphoma
- Being tested
- Latest generation chemotherapies for T-LBL + transplant
- Keywords
- T-lymphoblastic lymphoma, Intensive chemo/radiotherapy, Intensive chemotherapy, Transplant, Adult patients
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latest generation chemotherapies for T-LBL + transplantOther
- Standard doses of one of the following chemotherapies:
- Holzer
- LSA2-L2 modified
- Stanford regimen
- Hyper CVAD
- Sequential treatments analogous to the ones above mentioned (e.g.: GIMEMA LAL094, others)
- Intensive chemotherapy, ALL-type, MRD oriented (NILG-TLL Clinical Trial)
- Autologous transplant or allogeneic transplant or mini-allogeneic transplant
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Adult patients with T-lymphoblastic lymphoma treated with intensive chemo/radiotherapy or intensive chemotherapy followed by transplant. Receives: Other: Latest generation chemotherapies for T-LBL + transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
To create a prospective database of T-lymphoblastic lymphoma cases on adult patients in order to conduct an appropriate statistical study.
Measured: 5 years
Secondary outcomes (4)
To monitor histological and immunophenotypical diagnosis and to make a minimal residual disease (MRD) molecular study in order to verify if minimal residual disease (MRD) prognostic value observed in children is confirmed in adult patients.
Measured: 5 years
To make a gene expression analysis on T-Lymphoblastic Lymphoma patients to detect specific genetic profiles useful to give prognostic and therapy response advices.
Measured: 5 years
To validated the prognostic systems already identified in T-Acute Lymphoblastic Leukemia cases that can be useful to label the high-risk for Lymphoblastic Lymphoma patients.
Measured: 5 years
To evaluate if PET has a prognostic value in T-Lymphoblastic Lymphoma cases.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2014 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoblastic 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimo Federico, MD, Study director, Azienda Ospedaliero-Universitaria di Modena (MO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882011
- Sponsor's protocol ID
- IIL-LY_01
- Status last verified
- Oct 2011
- First submitted
- 15 Apr 2009
- Last updated
- 13 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Controlled Clinical Trials, on Adult Patients With T-lymphoblastic Lymphoma Treated With Intensive Chemo/Radiotherapy or Intensive Chemotherapy Followed by Transplant. Evaluation of Clinical, Anatomy-pathological Parameters
- ClinicalTrials.gov ID
- NCT00882011
- Acronym / sponsor ID
- IIL-LY_01
- Conditions
- Lymphoblastic Lymphoma
- Keywords
- T-lymphoblastic lymphoma, Intensive chemo/radiotherapy, Intensive chemotherapy, Transplant, Adult patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 16 Apr 2009 (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.
The purpose of the study is to create a prospective database of T-Lymphoblastic Lymphoma (T-LBL) cases in order to conduct an appropriate statistical study as well as to monitor diagnosis and minimal residual disease (MRD), to detect specific genetic profile useful to give advices on therapies, to assess if PET has a prognostic validity on T-Lymphoblastic Lymphoma (T-LBL).
Detailed description
Observational prospective Clinical Trial designed to:
- record all patients treated with a latest generation ALL-like therapy (e.g.: Holzer, LSA2-L2 modified, GIMEMA LAL094), an enhanced therapy (hyper-CVAD or Stanford), autologous or allogeneic transplant or reduced intensity conditioning allotransplant after induction/consolidation and also expected cases treated with high dose sequential therapy or intensified minimal residual disease (MRD) oriented therapy;
- enter classic T-LBL patients (bone marrow infiltrate <25%) treated as long as previous section;
- monitor therapy response/phenotype ratio by the study of phenotype;
- monitor therapy response/residual disease/patients outcome ratio by the study of T-cell receptor gene rearrangement;
- evaluate any gene-profile difference between T-LBL pre-thymic phenotype and T-LBL thymic phenotype so as to correlate it to outcome;
- monitor the stage of the disease at diagnosis, during the therapy and during the follow-up by means of TAC, so to value if PET (in association with TAC) is an additional and/or outcome predicting element compared to TAC.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Other: Latest generation chemotherapies for T-LBL + transplantAdult patients with T-lymphoblastic lymphoma treated with intensive chemo/radiotherapy or intensive chemotherapy followed by transplant. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients with T-lymphoblastic lymphoma treated with intensive chemo/radiotherapy or intensive chemotherapy followed by transplant.
Key inclusion criteria (10 listed)
- no previous therapy, except for treatments to face up to clinical presentation of emergency;
- medical history initially characterized by nodal mass/masses;
- histological and immunophenotypic diagnosis that documents the diagnosis of T-LBL; in cases of bone marrow involvement and difficulties in obtaining nodal material, diagnosis could be based on bone marrow;
- availability of biological material for the study of TCR and gene-profile;
- age ≥ 15 years;
Key exclusion criteria (2 listed)
- patients with previous HCV, HBsAg+ or suffering from HIV;
- patients with organic pathology not related to lymphoma.
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 |
|---|---|---|
| Latest generation chemotherapies for T-LBL + transplant1. Standard doses of one of the following chemotherapies: * Holzer * LSA2-L2 modified * Stanford regimen * Hyper CVAD * Sequential treatments analogous to the ones above mentioned (e.g.: GIMEMA LAL094, others) * Intensive chemotherapy, ALL-type, MRD oriented (NILG-TLL Clinical Trial) 2. Autologous transplant or allogeneic transplant or mini-allogeneic transplant | Other | Arm 1 |
Primary outcome
To create a prospective database of T-lymphoblastic lymphoma cases on adult patients in order to conduct an appropriate statistical study.
Time frame: 5 years
4 secondary outcomes
To monitor histological and immunophenotypical diagnosis and to make a minimal residual disease (MRD) molecular study in order to verify if minimal residual disease (MRD) prognostic value observed in children is confirmed in adult patients.
Time frame: 5 years
To make a gene expression analysis on T-Lymphoblastic Lymphoma patients to detect specific genetic profiles useful to give prognostic and therapy response advices.
Time frame: 5 years
To validated the prognostic systems already identified in T-Acute Lymphoblastic Leukemia cases that can be useful to label the high-risk for Lymphoblastic Lymphoma patients.
Time frame: 5 years
To evaluate if PET has a prognostic value in T-Lymphoblastic Lymphoma cases.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2011.
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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.
Massimo Federico, MD study director
Azienda Ospedaliero-Universitaria di Modena (MO)
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoblastic Lymphoma, run by Fondazione Italiana Linfomi - ETS at 17 sites in Italy.
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 10 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: status not confirmed, as of the sponsor's last update on 13 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sonia Perticone, PhD (+390131206071, segreteria@filinf.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To create a prospective database of T-lymphoblastic lymphoma cases on adult patients in order to conduct an appropriate statistical study. (time frame: 5 years). 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 13 Oct 2011.