Dose-dense modified R-CHOP regimen (R-COMP) in patients with aggressive NHL.
Conditions
Interventions
Trade Name: Myocet
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Doxorrubicina Clorhidrato (HCl)
CAS Number: 25316-40-9
Current Sponsor code: CN 919183
Other d
Sponsors
(GOTEL) Grupo Oncológico para el tratamiento y estudio de los linfomas
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. To evaluate the safety and tolerability of R-COMP-14 regimen as first line of treatment for patients with aggressive NHL. ;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. | — |
Countries
Spain
Outcome results
None listed