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

NCT00244127 | Unknown Phase 2

• 2 other identifiers: Myocet 018The MYOCAN Study
• Study Type: interventional
• Target: 75
• Locations: 5 countries
• Sites: 5

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.

Conditions

Aggressive Non-Hodgkin's Lymphoma in the Elderly.

Outcome Measures

Primary Outcomes (1)

• Response rate

Interventions

Cyclophosphamide, oncovin, myocet, prednisone & rituximab (R-COMP) DRUG

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zeneus Pharma: lead

Study Sites (5)

Unknown Facility

Paris, France

Location

Unknown Facility

Berlin, Germany

Location

Universita Degli Studi Di Modena AZ Ospedaliere Policlinico

Modena, 41100, Italy

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Leicester, United Kingdom

Location

MeSH Terms

Interventions

Cyclophosphamide; Vincristine; Doxorubicin; Prednisone; Rituximab

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Massimo Federico

  Universita Degli Studi di Modena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 24, 2005
• First Posted: October 25, 2005
• Study Start: October 1, 2002
• Last Updated: October 28, 2005

Record last verified: 2005-10

Locations

IT (1); FR (1); ES (1); DE (1); GB (1)