No Hodgkin B LymphomaPhase 2NCT00849355
Ciclophosphamide, Vincristine, Myocet and Prednisone, With Rituximab in 1st-Line Treatment for Patients With No-Hodgkin B Lymphoma and Cardiovascular (CV) Risk
A Phase 2 study testing RCOMP-14 + rituximab in people with No Hodgkin B Lymphoma, run by Asociacion Doctor Peset Para el Estudio de la Hematología at 12 sites in Spain.
Trial summary
The purpose of this study is to evaluate the efficacy (and safety) of the following treatment squeme:Ciclophosphamide, Vincristine, lyposomal Doxorrubicine (Myocet) and Prednisone,combined with Rituximab in first line treatment for patients with aggresive No Hodgkin B lymphoma and cardiovascular risk Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- No Hodgkin B Lymphoma
- What is being tested?
- RCOMP-14 + rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 12 sitesSpain
- Study dates
- Aug 2008to Nov 2010
- 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 histological diagnosis of Lymphoma no Hodgkin B CD20+ high degree of mailgnancy
- Patients no previously treated
- stage III o IV
- Informed consent
- At least one measurable injury
- Age >18
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- ECOG 0-2
- Life expectancy >6 months
- Cardiovascular risk defined as:Mild-moderate systolic dysfunction,isquemic cardiopathy, diabetes mellitus, hypertension,left ventricular hypertrophy, cardiac arrhythmia, moderate pulmonar hypertension
- adequate organic functionallity (creatinine<2mg/dl;bilirubin<2mg/dl; ALT-AST-FA<5 FSN; neutrphyls total count >1.5x 109/l and platellet count >100x1097l)
- Use of a contraceptive method during study + 3 months -
Who cannot join
- stage I or II with IPI=0
- Symptomatic tumoral affection of Nervous central system
- Lymphoma no hodgkin B indolent
- Lymphoma no hodgkin B mantle-cell
- Lymphoma no hodgkin T
- lymphoprolifertaive syndrome post-transplantation or immunosuppression associated
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- cardiovacualr disease symptomatic
- Cronic infection or acute serious
- history of neoplasia in past 5 years
- not able to understand the study or poor protocol adherence
- Known Hypersensivity to any atudy drug
- pregnant/lactant women
- Previous participation in clinicla study in past 30 days
- Previous treatment with antraciclines or any drug used in this study
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites, 4 recruiting
- Active, not recruiting
hospital del Mar
Barcelona, 08003
- Active, not recruiting
Hospital Vall D'Hebrón
Barcelona, 08035
- Active, not recruiting
Hospital de Castellon
Castellon, 12004
- Not yet recruiting
Hospital Severo Ochoa
Madrid, 28211
Pedro Sanchez, +34914818000, psanchez.hsvo@salud.madrid.org
- Active, not recruiting
Hospital Universitario Puerta de Hierro
Madrid, 28220
- Recruiting
Hospital de Getafe
Madrid
Jose García, +34916839360, garciavela.joseantonio@gmail.com
- Active, not recruiting
Hospital son Llatzer
Mallorca, 07198
- Not yet recruiting
Hospital Morales Messeguer
Murcia, 30008
Jose Sanchez, +34606388315, josej.sanchezz3@carm.es
- Not yet recruiting
Hospital Santa Mª del Rosell
Murcia, 30203
Antonio Martinez, +34968504800, amartifran@ono.com
- Active, not recruiting
Hospital general universitario de Valencia
Valencia, 46014
- Active, not recruiting
H. Arnau de Vilanova
Valencia, 46015
- Active, not recruiting
Hospital Universitario Dr. Peset
Valencia, 46017
About this study
Official title: Phase II, Multicenter Trial to Evaluate the Efficacy and Safety of the Following Treatment Squeme:Ciclophosphamide, Vincristine, Lyposomal Doxorrubicine, Myocet and Prednisone,Combined With Rituximab in First Line Treatment for Patients With Aggresive No Hodgkin B Lymphoma and Cardiovascular Risk
The purpose of this study is to evaluate the efficacy (and safety) of the following treatment squeme:Ciclophosphamide, Vincristine, lyposomal Doxorrubicine (Myocet) and Prednisone,combined with Rituximab in first line treatment for patients with aggresive No Hodgkin B lymphoma and cardiovascular risk
Read the detailed description
Phase II, multicenter, open , 1-arm study.
- Conditions
- No Hodgkin B Lymphoma
- Being tested
- RCOMP-14 + rituximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RCOMP-14 + rituximabDrug
Pretreatment: vincristine 1mg at day -6 and Methylprednisolone 100 mg from -6 to day 0.
Treatment: rituximab 375m/m2 + ciclophosphamide 750 mg/m2 + Vincristine 1.4 mg/m2 + Doxorrubicine 50 mg/m2 at day 1 and every 14d. Prednisone 100 mg/d from day 1 to 5 and every 14 d.
| Study group | Role | What they receive |
|---|---|---|
| unique | Experimental | RCOMP-14 with Rituximab Receives: Drug: RCOMP-14 + rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate treatment efficacy by measuring response to treatment
Measured: at the end of study
Secondary outcomes (9)
evaluate cardiotoxicity and tolerability
Measured: At the end of study
Evaluate progression free survival
Measured: At the end of study
Evaluate event free survival
Measured: At the end of study
Evaluate tumor free survival
Measured: At the end of study
Evaluate overall survival
Measured: At the end of study
Evaluate response duration
Measured: At the end of study
treatment adherence
Measured: At the end of study
time to progression
Measured: At the end of the study
dose intensity and relative dose intensity
Measured: At the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startAug 2008
- Primary completionNov 2009 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Hodgkin B 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asociacion Doctor Peset Para el Estudio de la Hematología
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon, Pivotal S.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849355
- Sponsor's protocol ID
- ADOPEH-LINFMYO-2007
- Status last verified
- Feb 2009
- First submitted
- 20 Feb 2009
- Last updated
- 23 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Multicenter Trial to Evaluate the Efficacy and Safety of the Following Treatment Squeme:Ciclophosphamide, Vincristine, Lyposomal Doxorrubicine, Myocet and Prednisone,Combined With Rituximab in First Line Treatment for Patients With Aggresive No Hodgkin B Lymphoma and Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT00849355
- Acronym / sponsor ID
- ADOPEH-LINFMYO-2007
- Conditions
- No Hodgkin B Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Asociacion Doctor Peset Para el Estudio de la HematologíaUniversity, hospital or other
- Collaborators
- Cephalon, Pivotal S.L.
- Study start
- Aug 2008
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 23 Feb 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 this study is to evaluate the efficacy (and safety) of the following treatment squeme:Ciclophosphamide, Vincristine, lyposomal Doxorrubicine (Myocet) and Prednisone,combined with Rituximab in first line treatment for patients with aggresive No Hodgkin B lymphoma and cardiovascular risk
Detailed description
Phase II, multicenter, open , 1-arm study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| unique | Experimental | Drug: RCOMP-14 + rituximabRCOMP-14 with Rituximab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with histological diagnosis of Lymphoma no Hodgkin B CD20+ high degree of mailgnancy
- Patients no previously treated
- stage III o IV
- Informed consent
- At least one measurable injury
Key exclusion criteria (14 listed)
- stage I or II with IPI=0
- Symptomatic tumoral affection of Nervous central system
- Lymphoma no hodgkin B indolent
- Lymphoma no hodgkin B mantle-cell
- Lymphoma no hodgkin T
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 |
|---|---|---|
| RCOMP-14 + rituximabPretreatment: vincristine 1mg at day -6 and Methylprednisolone 100 mg from -6 to day 0. Treatment: rituximab 375m/m2 + ciclophosphamide 750 mg/m2 + Vincristine 1.4 mg/m2 + Doxorrubicine 50 mg/m2 at day 1 and every 14d. Prednisone 100 mg/d from day 1 to 5 and every 14 d. | Drug | unique |
Primary outcome
Evaluate treatment efficacy by measuring response to treatment
Time frame: at the end of study
9 secondary outcomes
evaluate cardiotoxicity and tolerability
Time frame: At the end of study
Evaluate progression free survival
Time frame: At the end of study
Evaluate event free survival
Time frame: At the end of study
Evaluate tumor free survival
Time frame: At the end of study
Evaluate overall survival
Time frame: At the end of study
Evaluate response duration
Time frame: At the end of study
treatment adherence
Time frame: At the end of study
time to progression
Time frame: At the end of the study
dose intensity and relative dose intensity
Time frame: At the end of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2009.
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.
12 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 RCOMP-14 + rituximab in people with No Hodgkin B Lymphoma, run by Asociacion Doctor Peset Para el Estudio de la Hematología at 12 sites in Spain.
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 11 inclusion and 14 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 23 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. 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 Secundino Ferrer (+34961622536, ferrer_sec@gva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate treatment efficacy by measuring response to treatment (time frame: at the end of study). 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 23 Feb 2009.