Diffuse Large B-Cell LymphomaPhase 2NCT01009970
Study With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet®), Vincristine, Prednisone, (R-COMP) to Treat Non-Hodgkin's Lymphoma
A Phase 2 study testing Rituximab, Cyclophosphamide and Vincristine in people with Diffuse Large B-Cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 32 sites in Italy.
Trial summary
This is a multicenter study phase II, open-label for cardiopathic patients affected by Non-Hodgkin's lymphoma diffuse large B cell CD20 + grade IIIb follicular. The purpose is to study the feasibility of R-COMP in this cohort of patients. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- Rituximab, Cyclophosphamide and Vincristine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 32 sitesItaly
- Study dates
- May 2010to May 2012
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- NHL histological diagnosis of diffuse large B cell CD20 + (de novo or shift from low-grade NHL if not pretreated), grade IIIb follicular NHL;
- Age >= 18 years;
- Presence of at least 1 factor that defines the cardiopathy;
- Life expectancy > 3 months;
- In the case of women of childbearing age absence of pregnancy at the beginning of the chemotherapy;
- Written informed consent.
Who cannot join
- Histology different from NHL diffuse large cell CD20 + or follicular IIIb
- Age < 18 years
- Inability to sign informed consent;
- HIV positivity;
- Patients HBsAg positive;
- AST/ALT > 2 times the standard;
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- Bilirubin > 2 times the standard;
- Creatinine > 2.5 mg / dl;
- Location of CNS disease;
- Pregnancy ongoing;
- Damage to that organ or medical problems that could interfere with the therapy;
- Current uncontrolled infection;
- Senile dementia
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Italy32 sites, 32 recruiting
- Recruiting
Ospedale SS Antonio Biagio e Cesare Arrigo
Alessandria
Alessandro Levis, MD
- Not yet recruiting
Università di Bari
Bari
Giorgina Specchia, MD
- Not yet recruiting
Ospedale degli Infermi
Biella
Anna Tonso, MD
- Not yet recruiting
Spedali Civili
Brescia
Giuseppe Rossi, MD
- Not yet recruiting
Ospedale Civitanova Marche
Civitanova Marche
Riccardo Centurioni, MD
- Not yet recruiting
AO Annunziata
Cosenza
- Not yet recruiting
Ospedale San Carlo
Cosenza
Attilio Olivieri, MD
- Not yet recruiting
Ospedale Vito Fazzi
Lecce
Nicola Di Renzo, MD
- Not yet recruiting
Istituto Scientifico Romagnolo per lo studio e la cura dei tumori (IRST)
Meldola (FC)
Dino Amadori, MD
- Not yet recruiting
A O Papardo
Messina
Maura Brugiatelli, MD
- Not yet recruiting
Ospedale Niguarda Cà Granda
Milan
Livio Gargantini, MD
- Not yet recruiting
Ospedale San Raffaele
Milan
Andres Ferreri, MD
- Recruiting
Centro oncologico modenese
Modena
Massimo Federico, MD
- Not yet recruiting
AO Universitaria Paolo Giaccone
Palermo
Salvatrice Mancuso, MD
- Not yet recruiting
Ospedale La Maddalena
Palermo
Maurizio Musso, MD
- Not yet recruiting
A O Universitaria di Parma
Parma
Vittorio Rizzoli, MD
- Not yet recruiting
Ospedale Santa Maria della Misericordia
Perugia
Leonardo Flenghi, MD
- Not yet recruiting
Ausl Ravenna
Ravenna
Alfonso Zaccaria, MD
- Not yet recruiting
Ospedale Bianchi Melacrino Morelli
Reggio Calabria
Caterina Stelitano, MD
- Not yet recruiting
AO Santa Maria Nuova
Reggio Emilia
Francesco Merli, MD
- Not yet recruiting
Ausl Rimini
Rimini
Pier Paolo Fattori, MD
- Not yet recruiting
Istituto Regina Elena
Roma
Antonio Spadea, MD
- Not yet recruiting
Ospedale Sant'Eugenio
Roma
Elisabetta Abruzzese, MD
- Not yet recruiting
Università La Sapienza
Roma
Maurizio Martelli, MD
- Not yet recruiting
Clinica Humanitas
Rozzano (MI)
Balzarotti Monica, MD
- Not yet recruiting
Casa sollievo della sofferenza
San Giovanni Rotondo
Nicola Cascavilla, MD
- Not yet recruiting
Università di Sassari
Sassari
Maurizio Longinotti, MD
- Not yet recruiting
Azienda Ospedaliera senese
Siena
Alberto Fabbri, MD
- Not yet recruiting
Ospedale San Giovanni Battista Molinette
Torino
Umberto Vitolo, MD
- Not yet recruiting
Ospedale Riuniti
Trieste
Gabriele Pozzato, MD
- Not yet recruiting
Santa Maria della Misericordia
Udine
Francesco Zaja, MD
- Not yet recruiting
Ospedale di circolo e Fondazione Macchi
Varese
Gabriella Pinotti, MD
About this study
Official title: Multicenter Study of Phase II With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet ®), Vincristine, Prednisone, (R-COMP) in Non-Hodgkin's Lymphoma Diffuse Large B Cell in Cardiopathic Patients
This is a multicenter study phase II, open-label for cardiopathic patients affected by Non-Hodgkin's lymphoma diffuse large B cell CD20 + grade IIIb follicular. The purpose is to study the feasibility of R-COMP in this cohort of patients.
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- Rituximab, Cyclophosphamide, Vincristine, Prednisone, Doxorubicin
- Keywords
- Diffuse Large B-Cell Lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
375 mg/m2 day 1
CyclophosphamideDrug
750 mg/m2 day 2
VincristineDrug
1,4 mg/m2 (max 2 mg) day 2
PrednisoneDrug
40 mg/m2 day 2-6
DoxorubicinDrug
50 mg/m2 day 2
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | R-COMP Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone; Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of R-COMP in cardiopathic patients
Measured: 2 years
Secondary outcomes (3)
Response rates
Measured: 1 year
Progression free survival
Measured: 2 years
Overall Survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2009 (estimated)
- Study startMay 2010
- Primary completionMay 2011
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michele Spina, MD, Study director, Centro di riferimento Oncologico di Aviano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009970
- Sponsor's protocol ID
- IIL-HEART01
- Other IDs
- 2009-012143-42, 2009
- Status last verified
- Oct 2011
- First submitted
- 6 Nov 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
- Multicenter Study of Phase II With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet ®), Vincristine, Prednisone, (R-COMP) in Non-Hodgkin's Lymphoma Diffuse Large B Cell in Cardiopathic Patients
- ClinicalTrials.gov ID
- NCT01009970
- Acronym / sponsor ID
- IIL-HEART01
- Conditions
- Diffuse Large B-Cell Lymphoma
- Keywords
- Diffuse Large B-Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2012 (estimated)
- First posted
- 9 Nov 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.
This is a multicenter study phase II, open-label for cardiopathic patients affected by Non-Hodgkin's lymphoma diffuse large B cell CD20 + grade IIIb follicular. The purpose is to study the feasibility of R-COMP in this cohort of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Rituximab, Drug: Cyclophosphamide, Drug: Vincristine, Drug: Prednisone, Drug: DoxorubicinR-COMP |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- NHL histological diagnosis of diffuse large B cell CD20 + (de novo or shift from low-grade NHL if not pretreated), grade IIIb follicular NHL;
- Age >= 18 years;
- Presence of at least 1 factor that defines the cardiopathy;
- Life expectancy > 3 months;
- In the case of women of childbearing age absence of pregnancy at the beginning of the chemotherapy;
Key exclusion criteria (13 listed)
- Histology different from NHL diffuse large cell CD20 + or follicular IIIb
- Age < 18 years
- Inability to sign informed consent;
- HIV positivity;
- Patients HBsAg positive;
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 |
|---|---|---|
| Rituximab375 mg/m2 day 1 | Drug | 1 |
| Cyclophosphamide750 mg/m2 day 2 | Drug | 1 |
| Vincristine1,4 mg/m2 (max 2 mg) day 2 | Drug | 1 |
| Prednisone40 mg/m2 day 2-6 | Drug | 1 |
| Doxorubicin50 mg/m2 day 2 | Drug | 1 |
Primary outcome
Feasibility of R-COMP in cardiopathic patients
Time frame: 2 years
3 secondary outcomes
Response rates
Time frame: 1 year
Progression free survival
Time frame: 2 years
Overall Survival
Time frame: 3 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.
Michele Spina, MD study director
Centro di riferimento Oncologico di Aviano
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab, Cyclophosphamide and Vincristine in people with Diffuse Large B-Cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 32 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 6 inclusion and 13 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 32 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Denaro (0039-0131-206129, ddenaro@ospedale.al.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of R-COMP in cardiopathic patients (time frame: 2 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.