Phase 2
N=60
R-BMD in Refractory or Relapsed Lymphoma, GELTAMO Clinical Trial
Non-Hodgkin's Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01133158 ↗Enrolled (actual)
60
Serious AEs
36.7%
Results posted
Nov 2018
Primary outcome: Primary: Response Rate — 57; 35 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rituximab, Bendamustine, Mitoxantrone, Dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate |
57; 35 | — |
| SECONDARY Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response. |
56; 51; NA; 54 | — |
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
- Age ≥ 18 and ≤ 75 years.
- 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.
- 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).
- ECOG ≤ 2.
- Signed written informed consent.
Exclusion Criteria
- Clinical suspicion or documentation of histological transformation.
- Have received prior chemotherapy scheme, first line without Rituximab.
- Prior autologous or allogeneic.
- CNS infiltration by LF (primary CNS lymphoma or lymphomatous meningitis).
- Past or active Hepatitis B (at least one of the following markers HBsAg, HBe Ag, anti-HBc, HBV DNA)
- HCV infection. HIV infection or other conditions of serious immunosuppression.
- Previous neoplasms except non-melanoma skin cancer of the cervix or adequately treated.
- Cardiac function in cardiac patient known or prior treatment with anthracyclines with EF 1.5 x Upper Limit of Normal, LSN) or a creatinine clearance 2 x ULN) were not related to lymphoma.
- 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.
- Patients with heart disease, pulmonary, neurological, psychiatric or severe metabolic and not secondary to lymphoma.
- Severe acute or chronic infection in activity.
- Any other concurrent medical or psychological comorbidity that might interfere with participation in this study.
Data sourced from ClinicalTrials.gov (NCT01133158). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.