R-BMD in Refractory or Relapsed Lymphoma, GELTAMO Clinical Trial
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
Intervention description: Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv Dexamethasone 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv
Intervention MeSH terms: Dexamethasone; Rituximab; Bendamustine Hydrochloride; Mitoxantrone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Follicular non-Hodgkin's lymphoma relapse refractory

Summary:

      Assess the combination of efficacy of the combination of rituximab, bendamustine,
      mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 18 and ≤ 75 years.

          2. Patients with follicular lymphoma grade 1, 2 or 3a, CD20 +, histologically confirmed
             lymph node biopsy or tissue. Be accepted diagnosis in bone marrow if no accessible
             lymph nodes and whether it has discarded the mantle LLC, and NHL.

          3. Follicular lymphoma patients treated with the combination of rituximab and
             chemotherapy in first line, which have been refractory or relapsed after having
             achieved any responses to this first line of pretreatment (excluding radiotherapy).

          4. ECOG ≤ 2.

          5. Signed written informed consent.

        Exclusion Criteria:

          1. Clinical suspicion or documentation of histological transformation.

          2. Have received prior chemotherapy scheme, first line without Rituximab.

          3. Prior autologous or allogeneic.

          4. CNS infiltration by LF (primary CNS lymphoma or lymphomatous meningitis).

          5. Past or active Hepatitis B (at least one of the following markers HBsAg, HBe Ag,
             anti-HBc, HBV DNA)

          6. HCV infection. HIV infection or other conditions of serious immunosuppression.

          7. Previous neoplasms except non-melanoma skin cancer of the cervix or adequately
             treated.

          8. Cardiac function in cardiac patient known or prior treatment with anthracyclines with
             EF <50%.

          9. Impaired renal function (creatinine> 1.5 x Upper Limit of Normal, LSN) or a creatinine
             clearance <50 ml / h, not related to lymphoma.

         10. Impaired liver function (bilirubin, AST / ALT or GGT> 2 x ULN) were not related to
             lymphoma.

         11. Women who are nursing or pregnant. Women of childbearing potential will be included
             prior pregnancy test serum / urine negative. Use effective contraception to be kept
             for 1 year after cessation of rituximab.

         12. Patients with heart disease, pulmonary, neurological, psychiatric or severe metabolic
             and not secondary to lymphoma.

         13. Severe acute or chronic infection in activity.

         14. Any other concurrent medical or psychological comorbidity that might interfere with
             participation in this study.