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

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.

Study Overview

• Status: Unknown
• Conditions: Aggressive Non-Hodgkin's Lymphoma in the Elderly.
• Intervention / Treatment: Drug: Cyclophosphamide, oncovin, myocet, prednisone & rituximab (R-COMP)

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 Type: Interventional
• Enrollment: 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Paris, France
• Germany
  • Berlin, Germany
• Italy
  • Modena, Italy, 41100
    • Universita Degli Studi Di Modena AZ Ospedaliere Policlinico
• Spain
  • Barcelona, Spain
• United Kingdom
  • Leicester, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate

Collaborators and Investigators

• Sponsor: Zeneus Pharma
• Investigators: Principal Investigator: Massimo Federico, Università degli Studi di Modena

Study record dates

Study Major Dates

• Study Start: October 1, 2002

Study Registration Dates

• First Submitted: October 24, 2005
• First Submitted That Met QC Criteria: October 24, 2005
• First Posted (Estimate): October 25, 2005

Study Record Updates

• Last Update Posted (Estimate): October 28, 2005
• Last Update Submitted That Met QC Criteria: October 26, 2005
• Last Verified: October 1, 2005

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Aggression; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Cyclophosphamide; Rituximab; Prednisone; Vincristine
• Other Study ID Numbers: Myocet 018; The MYOCAN Study