Open Label, Single Arm, Phase II Study Using R-COMP in Elderly Patients With Aggressive NHL.
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
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
Outcome Measures
Primary Outcome Measures
- Response rate []
Eligibility Criteria
Criteria
Inclusion Criteria:
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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;
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Primary diffuse large B-cell lymphoma of MALT (incorrectly defined as high-grade MALT lymphoma);
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Marginal zone B-cell lymphoma with coexisting areas of DLBCL;
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Age of ≥60 years;
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Clinical stage at diagnosis: I A bulky - IV B;
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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;
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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);
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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)
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Left ventricular ejection fraction (LVEF) ≥50%;
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ECOG performance status 0-2;
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At least one measurable lesion is mandatory;
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Written informed consent given at time of registration;
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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).
Exclusion Criteria:
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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);
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Tumour involvement of CNS;
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Indolent lymphoma transformed in more aggressive histological type, even if never previously treated;
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Mantle Cell Lymphoma, Peripheral T cell Lymphoma and their variants;
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Aggressive non-Hodgkin's lymphoma in transplanted patient;
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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;
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Concurrent malignancy or history of other malignancy, except basal cell carcinoma of the skin (BCC) and in-situ cervical carcinoma (CIN) / Myelodysplastic syndrome;
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HbsAg, HIV-positive, or HCV-RNA-positive patients;
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Inability to comply with study procedures;
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Prior CNS lymphoma;
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Prior radiation to non-CNS lymphoma mass(es) as a treatment for lymphomas;
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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;
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Presence of other medication that may interfere with study treatment or the action of the investigational product or confuse the assessment of study results
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Pregnant women or nursing mothers;
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Participation in an investigational drug study within 4 weeks prior to study entry.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Paris | France | |||
2 | Berlin | Germany | |||
3 | Universita Degli Studi Di Modena AZ Ospedaliere Policlinico | Modena | Italy | 41100 | |
4 | Barcelona | Spain | |||
5 | Leicester | United Kingdom |
Sponsors and Collaborators
- Zeneus Pharma
Investigators
- Principal Investigator: Massimo Federico, Universita Degli Studi di Modena
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Myocet 018
- The MYOCAN Study