Open Label, Single Arm, Phase II Study Using R-COMP in Elderly Patients With Aggressive NHL.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cyclophosphamide, Oncovin, Myocet, Prednisone and Rituximab (R-COMP) in the Treatment of Elderly Patients With Aggressive NHL.

Conditions
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Aggressive Non-Hodgkin's Lymphoma in the Elderly.

Intervention / Treatment
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* Drug: Cyclophosphamide, oncovin, myocet, prednisone & rituximab (R-COMP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; 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). Exclusion Criteria: 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; 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cyclophosphamide, oncovin, myocet, prednisone & rituximab (R-COMP)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  |