First line treatment with Rituximab asociated to CVP plus Interferon in Follicular Lymphoma. Phase II study.Asociación de Rituximab al esquema CVP + Interferón en el tratamiento de primera línea del linfoma folicular - R-CVP-IF

• Conditions: ntreated grade 1 and 2 Follicular Lymphoma

• Registration Number: EUCTR2005-004761-42-ES
• Lead Sponsor: Fundacion Leucemia y Linfoma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Age =18 and = 75 years.
- Grade 1 or 2 Follicular Lymphoma, Marginal Zone Lymphoma or Lymphocitic Lymphoma (with no CLL criteria) confirmed by nodal tissue. Patients with diagnosis made in bone marrow trephine will be accepted, if no adenopathy is detected and MCL or CLL are ruled out.
- Follicular Lymphoma International Prognostic Index (FLIPI) = 2.
- No prior chemotherapy of radiotherapy. Local radiation is accepted.
- Adequate hepatic and renal function (acceted if related to LNH infiltration)
- Correct Thyroid function
- ECOG performance status 0 to 3.
- Abscence of other malignancies or impariment to receive thge drugs in the study.
- Signed approved informed consent before any study specific procedures are performed.

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

- Prior chemotherapy of radiotherapy.
- Active second malignancy in the previous 5 years.
- Previous Psiquiatric disease, specially moderate to severe depression, psycosis, autolytic attempts.
- Uncontrolled current cardiopathy (myocardial infarction, angina, significant cardiac arrythmia or congestive heart failure)
- Diabetes mellitus insulin requirement.
- Uncontrolled hepatic or autoimmune disease.
- Female subjects who are breast-feeding
- Female subjects, who are not surgically sterile or post-menopausal, and do not use medically acceptable methods of birth control for the duration of the study and for one year after the last dose.
- Acute or ongoing chronic infectious disease.
- Immunocopromised subjects including subjects known to be HIV possitive or acute/chronic HCV or HBV positive.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified