Aggressive Non-Hodgkin's Lymphoma in the Elderly.Phase 2NCT00244127
Open Label, Single Arm, Phase II Study Using R-COMP in Elderly Patients With Aggressive NHL.
A Phase 2 study testing Cyclophosphamide, oncovin, myocet, prednisone & rituximab (R-COMP) in people with Aggressive Non-Hodgkin's Lymphoma in the Elderly., run by Zeneus Pharma at 5 sites in 5 countries.
Trial summary
To evaluate the safety and efficacy of R-COMP in elderly patients with advanced aggressive NHL. Myocet (non-pegylated liposomal doxorubicin) replaces conventional doxorubicin in the R-CHOP regimen. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aggressive Non-Hodgkin's Lymphoma in the Elderly.
- What is being tested?
- Cyclophosphamide, oncovin, myocet, prednisone & rituximab (R-COMP)
- How many people
- 75 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Oct 2002to not given
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diffuse Large B-Cell Lymphoma (DLBCL), and their morphologic variants and subtypes, i.e. Centroblastic lymphoma, Immunoblastic lymphoma, T-cell rich/B-cell lymphoma, anaplastic large B-cell lymphoma, mediastinal (thymic) large B-cell lymphoma;
- Primary diffuse large B-cell lymphoma of MALT (incorrectly defined as high-grade MALT lymphoma);
- Marginal zone B-cell lymphoma with coexisting areas of DLBCL;
- Age of ≥60 years;
- Clinical stage at diagnosis: I A bulky - IV B;
- CD20 positivity;
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- Serum negativity for HbsAg and HCV except for those with no sign of active viral replication, assessed by HCV-RNA copies;
- Absolute neutrophil count (ANC) ≥1.5x109/L, and platelet count ≥100x109/L (unless both are attributed directly to bone marrow involvement by lymphoma or auto-immune disease secondary to lymphoma);
- Serum creatinine ≤130μM/L, serum bilirubin ≤2.5xULN aspartate amino-transferase (AST/GOT), ≤2.5xULN alanine amino-transferase (ALT/GPT) ≤2.5xULN, and alkaline phosphatase ≤4 times the upper limit of normal (unless the increase is attributed directly to the presence of tumour by the Investigator)
- Left ventricular ejection fraction (LVEF) ≥50%;
- ECOG performance status 0-2;
- At least one measurable lesion is mandatory;
- Written informed consent given at time of registration;
- Males and females (both males and females of childbearing potential must agree to use adequate contraception for the duration, and for 3 months after the completion, of the treatment).
Who cannot join
- Clinical stage I non-bulky, or CS IIA with less than three sites of disease involved (patients with stage IIB are eligible, regardless of the number of sites involved);
- Tumour involvement of CNS;
- Indolent lymphoma transformed in more aggressive histological type, even if never previously treated;
- Mantle Cell Lymphoma, Peripheral T cell Lymphoma and their variants;
- Aggressive non-Hodgkin's lymphoma in transplanted patient;
- Clinically significant secondary cardiovascular disease, e.g. uncontrolled hypertension, (resting diastolic blood pressure >115 mmHg), uncontrolled multifocal cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure NYHA class III-IV;
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- Evidence of any severe active acute or chronic infection;
- Concurrent malignancy or history of other malignancy, except basal cell carcinoma of the skin (BCC) and in-situ cervical carcinoma (CIN) / Myelodysplastic syndrome;
- HbsAg, HIV-positive, or HCV-RNA-positive patients;
- Inability to comply with study procedures;
- Prior CNS lymphoma;
- Prior radiation to non-CNS lymphoma mass(es) as a treatment for lymphomas;
- History of allergic reaction to anthracyclines, eggs, and egg products or known sensitivities, or history of unusual reaction, to other components of, or treatments similar to, the investigational treatment regimen;
- Presence of other medication that may interfere with study treatment or the action of the investigational product or confuse the assessment of study results
- Pregnant women or nursing mothers;
- Participation in an investigational drug study within 4 weeks prior to study entry.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Italy1 site
Universita Degli Studi Di Modena AZ Ospedaliere Policlinico
Modena, 41100
About this study
Official title: Cyclophosphamide, Oncovin, Myocet, Prednisone and Rituximab (R-COMP) in the Treatment of Elderly Patients With Aggressive NHL.
To evaluate the safety and efficacy of R-COMP in elderly patients with advanced aggressive NHL. Myocet (non-pegylated liposomal doxorubicin) replaces conventional doxorubicin in the R-CHOP regimen.
Read the detailed description
To evaluate the duration of remission, disease free survival and 2-year survival of R-COMP in first line therapy of elderly patients with advanced aggressive NHL.
To evaluate the tolerability of R-COMP in first line therapy of elderly patients with advanced aggressive NHL.
- Being tested
- Cyclophosphamide, oncovin, myocet, prednisone & rituximab (R-COMP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclophosphamide, oncovin, myocet, prednisone & rituximab (R-COMP)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2005 (estimated)
- Study startOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aggressive Non-Hodgkin's Lymphoma in the Elderly.Studies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- Zeneus Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Massimo Federico, Principal investigator, Universita Degli Studi di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244127
- Sponsor's protocol ID
- Myocet 018
- Other IDs
- The MYOCAN Study
- Status last verified
- Oct 2005
- First submitted
- 24 Oct 2005
- Last updated
- 28 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclophosphamide, Oncovin, Myocet, Prednisone and Rituximab (R-COMP) in the Treatment of Elderly Patients With Aggressive NHL.
- ClinicalTrials.gov ID
- NCT00244127
- Acronym / sponsor ID
- Myocet 018
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants
- Lead sponsor
- Zeneus PharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- First posted
- 25 Oct 2005 (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.
To evaluate the safety and efficacy of R-COMP in elderly patients with advanced aggressive NHL. Myocet (non-pegylated liposomal doxorubicin) replaces conventional doxorubicin in the R-CHOP regimen.
Detailed description
To evaluate the duration of remission, disease free survival and 2-year survival of R-COMP in first line therapy of elderly patients with advanced aggressive NHL.
To evaluate the tolerability of R-COMP in first line therapy of elderly patients with advanced aggressive NHL.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- Diffuse Large B-Cell Lymphoma (DLBCL), and their morphologic variants and subtypes, i.e. Centroblastic lymphoma, Immunoblastic lymphoma, T-cell rich/B-cell lymphoma, anaplastic large B-cell lymphoma, mediastinal (thymic) large B-cell lymphoma;
- Primary diffuse large B-cell lymphoma of MALT (incorrectly defined as high-grade MALT lymphoma);
- Marginal zone B-cell lymphoma with coexisting areas of DLBCL;
- Age of ≥60 years;
- Clinical stage at diagnosis: I A bulky - IV B;
Key exclusion criteria (16 listed)
- Clinical stage I non-bulky, or CS IIA with less than three sites of disease involved (patients with stage IIB are eligible, regardless of the number of sites involved);
- Tumour involvement of CNS;
- Indolent lymphoma transformed in more aggressive histological type, even if never previously treated;
- Mantle Cell Lymphoma, Peripheral T cell Lymphoma and their variants;
- Aggressive non-Hodgkin's lymphoma in transplanted patient;
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 |
|---|---|---|
| Cyclophosphamide, oncovin, myocet, prednisone & rituximab (R-COMP) | Drug | – |
Primary outcome
Response rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2005.
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 principal investigator
Universita Degli Studi di Modena
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide, oncovin, myocet, prednisone & rituximab (R-COMP) in people with Aggressive Non-Hodgkin's Lymphoma in the Elderly., run by Zeneus Pharma at 5 sites in 5 countries.
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 14 inclusion and 16 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 28 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Germany, Italy, Spain, United Kingdom. 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?
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?
Response rate. 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 28 Oct 2005.