R-BMD in Refractory or Relapsed Lymphoma, GELTAMO Clinical Trial

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Status and phase: Completed; Phase 2

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: Rituximab, Bendamustine, Mitoxantrone, Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01133158

R-BMD GELTAMO 08

Details and patient eligibility

About

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

Full description

Assess the combination of efficacy and safety of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma who are refractory or in relapse.

Enrollment: 61 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

61 participants in 1 patient group

R-BMD

Experimental group

Description:

Rituximab, Bendamustine, Mitoxantrone, Dexamethasone Induction: 6 Rituximab, Bendamustine, Mitoxantrone, Dexamethasone cycles Maintenance: Rituximab every 3 months for 2 years

Treatment:

Drug: Rituximab, Bendamustine, Mitoxantrone, Dexamethasone