Clinical trial NCT01127841: Trial of Rituximab, Bendamustine (RB) for Patients With Follicular Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line
Official title: Study Phase II Non-randomized Prospective Open to Assess the Combination of Rituximab, Bendamustine (RB) for Patients With Follicular Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Follicular Non-Hodgking´s Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line.
Lead sponsor: Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
Sponsor class: OTHER
First posted: 2010-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the effectiveness of rituximab, bendamustine (r) in terms of complete response and response complete not confirmed.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years.
2. Patients with follicular lymphoma grade 1, 2 or 3a, CD20 +, histologically confirmed lymph node biopsy or tissue.
3. Follicular lymphoma patients previously treated with the combination of rituximab and chemotherapy (R-CHOP, R-CVP, R-fludarabine), having received rituximab maintenance, refractory to a first line (excluding radiotherapy) or relapsed after having achieved any response to previous treatment.
4. ECOG ≤ 2.
5. Signed written informed consent

Exclusion Criteria:

1. Clinical suspicion or documentation of histological transformation.
2. Patients with hypersensitivity to rituximab.
3. Prior autologous or allogeneic transplant.
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 severe immunosuppression.
7. Previous neoplasms except non-melanoma skin cancer of the cervix or adequately treated.
8. Congestive heart failure\> NYHA grade 1.
9. Impaired renal function (creatinine\> 1.5 x Upper Limit of Normal, ULN) or 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.
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.

Primary outcomes:
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
timeFrame: Four years
Secondary outcomes:
measure: Secondary endpoint included an assessment of the following parameters:Global Survival,progression-Free survival,Disease-Free Survival,Duration of the Response.
timeFrame: Four years
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital de Elche
state: Alicante
city: Logroño
country: Spain
facility: Hospital San Pedro de La Rioja
state: La Rioja
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Malaga
city: Reus
country: Spain
facility: Hospital Sant Joan de Reus
state: Tarragona
city: Alicante
country: Spain
facility: Hospital G. U. de Alicante
city: Canarias
country: Spain
facility: Hospital Insular de Gran Canarias
city: Canarias
country: Spain
facility: Hospital U. de Gran Canarias Dr. Negrín
city: Huelva
country: Spain
facility: Hospital uan Ramón Jiménez
city: Mallorca
country: Spain
facility: Hospital Son Dureta
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
city: San Sebastian
country: Spain
facility: Instituto Oncologico de San Sebastian
city: Sevilla
country: Spain
facility: Hospital Virgen de la Macarena
city: Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital General de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
Study officials:
References: