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Study Phase II Non-randomized Prospective Open to Assess the Combination of Rituximab, Bendamustine, Mitoxantrone, Dexamethasone (R-BMD) in Patients With Follicular Lymphoma Refractory or Relapsed


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

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Trial Information

Study Phase II Non-randomized Prospective Open to Assess the Combination of Rituximab, Bendamustine, Mitoxantrone, Dexamethasone (R-BMD) in Patients With Follicular Lymphoma Refractory or Relapsed


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.


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.

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:

The primary endpoint is the complete response and unconfirmed complete response according to the criteria of the International Workshop to Standardize Response Criteria for NHL

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

Francisco Javier Peñalver Párraga, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Fundación de Alcorcon

Authority:

Spain: Spanish Agency of Medicines

Study ID:

R-BMD GELTAMO 08

NCT ID:

NCT01133158

Start Date:

July 2009

Completion Date:

December 2015

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Follicular non-Hodgkin's lymphoma in relapse or refractory to standard first-line immunochemotherapy
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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