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
18 Years
75 Years
Both
Non Hodgkin Lymphoma
Trial Information
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 use of monoclonal antibodies, specifically the chimerical humanized anti-CD20 monoclonal
antibody (Rituximab, MabThera®) represents one of the most innovative aspects in the
indolent lymphoma treatment. Preliminary data show from 40% to 50% of response with a median
response duration between 6 and 11 months in patients with relapsing FL. This response rate
increase when rituximab is administered as initial treatment.
Therefore, not only due to the clinical results but also to the tolerance, and based on an
innovative mechanism of action and in its minimal toxicity, it seems reasonable to raise
the possibility to incorporate the administration of the monoclonal antibody with
chemotherapeutic agents.
The development of a new treatment scheme that includes Rituximab administration within
treatment protocols that combine fludarabine and cyclophosphamide, whose results are better
than the ones obtained with conventional treatments such as CHOP, should increase the
molecular response rate and contribute therefore to increase the disease-free time interval
(time to progression), without adding any toxicity, in addition to achieve a higher
proportion of clinical responses (as global as complete responses). In order to increase the
time interval to progression, a maintenance treatment will be carried out for 2 years, which
has shown an evident benefit in the time to progression in preliminary studies.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to progression disease
Outcome Time Frame:
42 months
Safety Issue:
Yes
Principal Investigator
José F. Tomás, MD
Investigator Role:
Study Director
Investigator Affiliation:
Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon
Authority:
Spain: Spanish Agency of Medicines
Study ID:
LNHF-03.
NCT ID:
NCT01124526
Start Date:
September 2004
Completion Date:
July 2008
Related Keywords:
- Non Hodgkin Lymphoma
- R F C treatment in patients with Non Hodgkin Lymphoma
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Non-Hodgkin
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