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

Aggressive Non-Hodgkin's Lymphoma in the Elderly. Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00244127
• Other study ID #: Myocet 018
• Secondary ID: The MYOCAN Study
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 24, 2005
• Last updated: October 26, 2005
• Start date: October 2002

Study information

• Verified date: October 2005
• Source: Zeneus Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyItaly: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Ministry of Health and ConsumptionGermany: Ethics Commission
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aggression
• Aggressive Non-Hodgkin's Lymphoma in the Elderly.
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Cyclophosphamide, oncovin, myocet, prednisone & rituximab (R-COMP)

Locations

Country	Name	City	State
Italy	Universita Degli Studi Di Modena AZ Ospedaliere Policlinico	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Zeneus Pharma

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate