Non Hodgkin Lymphoma Clinical Trial
Official title:
Prospective Non-randomized Multicenter Study to Assess the Efficacy Response Duration and Toxicity of RFC as First-line Treatment and R as Maintenance Treatment, in Patients Diagnosed of Follicular Non Hodgkin Lymphoma
The purpose of this study is to determine whether the rituximab administration with fludarabine and cyclophosphamide results, are better, than the ones obtained with conventional therapy such as CHOP (cyclophosphamide, adriamycin, vincristine, prednisone) and also to determine whether the rituximab administration as maintenance treatment during two years, increase the global clinical responses and the disease free time interval.
Status | Completed |
Enrollment | 75 |
Est. completion date | July 2008 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Previously untreated patients with grade I-III follicular lymphoma (grade B- D from the Working Formulation, centrofollicular lymphoma in the REAL classification), without evidence of histological transformation. - Clinical diagnose by histological and/or immunophenotypical evaluation with positive results for CD 20 Mo Ab (node, bone marrow). - Ann-Arbor stage II-IV. - Male and female patients from 18 to 75 years old. - Lack of related clinically uncontrolled diseases. - Lack of VIH infection. - Performance status (ECOG) of 0, 1, 2. - Patients who voluntarily gave informed consent for the study participation. - Life expectancy > 3 months. Exclusion Criteria: - Pregnant or breast-feeding women. - Women of childbearing age who do not accept to use an effective contraceptive method during the treatment and one year post-treatment. - Immunodeficiency condition and autoimmune diseases. - Patients with advanced clinically uncontrolled cardiac, hepatic or renal insufficiency, defined by the following criteria: total bilirubin, alkaline phosphatase or transaminases >2 x upper limit of normal, and serum creatinine value >2 x upper limit of normal. - Patients previously treated with chemotherapy or radiotherapy. - History of oncologic disease within the last 5 years, apart from non-melanoma cutaneous neoplasia or carcinoma in situ of uterine cervix. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Príncipe de Asturias | Alcalá de Henares | Madrid |
Spain | Fundación Hospital Alcorcón | Alcorcón | Madrid |
Spain | Hospital Infanta Cristina | Badajoz | Badajoz_Extremadura |
Spain | Hospital del Mar | Barcelona | Barcelona_ Cataluña |
Spain | Instituto Catalán de Oncología (ICO) | Barcelona | Barcelona_Cataluña |
Spain | Hospital San Pedro de Alcántara | Cáceres | Cáceres_Extremadura |
Spain | Hospital de Fuenlabrada | Fuenlabrada | Madrid |
Spain | Hospital Severo Ochoa | Leganés | Madrid |
Spain | Complejo Hospitalario Xeral_Calde | Lugo | Lugo_ Galicia |
Spain | Fundación Jiménez Díaz | Madrid | |
Spain | Hospital Clínico San Carlos | Madrid | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Universitario Ramón y Cajal | Madrid | |
Spain | MD Anderson Internacional España | Madrid | |
Spain | Hospital de Móstoles | Móstoles | Madrid |
Spain | Hospital de Puerto Real | Puerto Real | Cádiz_ Andalucía |
Spain | Hospital Clínico Universitario de Salamanca | Salamanca | Salamanca_Castilla León |
Spain | Hospital General de Segovia | Segovia | Segovia_ Castilla León |
Spain | Hospital Clínico del Río Hortega | Valladolid | Valladolid_Castilla León |
Lead Sponsor | Collaborator |
---|---|
Asociacion Espanola de Hematologia y Hemoterapia |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to progression disease | 42 months | Yes | |
Secondary | Free-disease period | 54 months | Yes | |
Secondary | Overall survival | 54 months | Yes | |
Secondary | Safety of RFC | Toxicity is detailed and tabulate following the WHO classification. The safety analysis includes the incidence of adverse events (AE),vital signs and laboratory parameters. Impact tables are made of AE following the classification of preferred term. Also include an analysis of the intensity of AE and their relation to the combiantion of study treatment. |
54 months | Yes |
Secondary | Molecular monitoring of clinical response | Study of t14:18 translocation with altered expression of BCL2. | 54 months | Yes |
Status | Clinical Trial | Phase | |
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