Open Label, Single Arm, Phase II Study Using R-COMP in Elderly Patients With Aggressive NHL.
Phase 2
- Conditions
- Aggressive Non-Hodgkin's Lymphoma in the Elderly.
- Registration Number
- NCT00244127
- Lead Sponsor
- Zeneus Pharma
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 75
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Universita Degli Studi Di Modena AZ Ospedaliere Policlinico
🇮🇹Modena, Italy