A Phase II, Single Arm, Open label Study of Cyclophosphamide, Vincristine, Liposomal Doxorubicine (Myocet™) and Prednisone plus Rituximab in Fortnightly Regimen (R-COMP-14), as First Line of therapy for Patients with Aggressive Non Hodgkin’s Lymphoma (NHL).
- Conditions
- Dose-dense modified R-CHOP regimen (R-COMP) in patients with aggressive NHL.
- Registration Number
- EUCTR2004-001199-37-ES
- Lead Sponsor
- (GOTEL) Grupo Oncológico para el tratamiento y estudio de los linfomas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 75
•New diagnosticated patients with diffuse Large B-Cell Lymphoma (DLBCL), and their morphologic variants according to OMS classification
•At least one measurable lesion is mandatory
•CD20 + Lymphoma
•Age of = 18 and = 70 years
•Clinical stage at diagnosis: I or II (IPI = 1), III or IV.
•ECOG performance status 0-2
•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 = 2mg/dlL; serum bilirubin =2 mg /dl; (AST/GOT)/(ALT/GPT)/AP =5xULN, (unless the increase is attributed directly to the presence of tumour by the Investigator)
•Normal ECG; Left ventricular ejection fraction (LVEF) =50%
•Written informed consent given
•Patients of childbearing potential must agree to use adequate contraception for the duration, and for 3 months after the completion of the treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Clinical stage I or II if IPI = 0.
•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, uncontrolled multifocal cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure NYHA class III-IV
•Evidence of any severe active acute or chronic infection (including VIH, HbsAg or HCV)
•Concurrent malignancy or history of other malignancy, except properly tretated carcinoma of the skin non-melanoma, in-situ cervical carcinoma or Myelodysplastic syndrome
•Inability to comply with study procedures or to understand the study significance.
•Prior CNS lymphoma
•History of allergic reaction to anthracyclines, eggs (or derivatives) or known sensitivities, or history of unusual reaction, to other components of, or treatments similar to, the investigational treatment regimen
•Pregnant women or breast feeding womens
•Participation in a study with an investigational drug within 30 days prior to study entry.
•Previous treatment with anthracyclines and/or thoracic radiotherapy for any neoplasia.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the overall response rate of R-COMP regimen as first line of treatment for patients with aggressive NHL.;Secondary Objective: To evaluate the duration of response, disease free survival and overall survival of R-COMP-14 as first line of therapy for patients with aggressive NHL.<br><br>To evaluate the safety and tolerability of R-COMP-14 regimen as first line of treatment for patients with aggressive NHL.<br>;Primary end point(s): To evaluate antitumoral activity expressed as overall response rate in patients with agressive non-Hodgkin's lymphoma treated with R-COMP and bone marrow support every 14 days.
- Secondary Outcome Measures
Name Time Method