RituxCIM in relapsed or refractory indolent B-cell non-Hodgkin lymphoma

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 114

Inclusion Criteria

1.Patients that fulfill diagnosis criteria
2.Age greater than or equal to 18 years, of any gender.
3.Performance status less than or equal to 2 (ECOG).
4.Able and willing to give written informed consent.
5.Patients could have received any previous specific therapy (Chemotherapy/radiotherapy), provided that such treatment had ended, at least, 4 weeks before being included in the study.
6.Patients comply with the requirements of the clinical laboratory:
Hemoglobin= 100 g/L
ALC = 3 x 10?9 cells/L
ANC = 1,5x10?9 /L
platelets =100 x 10?9/L,
TGO/TGP= 2.5 time upper normal limits creatinine and bilirubin = 1.5 time upper normal limits.

Exclusion Criteria

1.Presence of brain metastasis.
2.Diagnosis of follicular lymphoma III B (clasiffied by WHO).
3.Patients who have been previously treated with corticosteroids, two weeks before inclusion
4.Uncontrolled hypertension
5.History of demyelinated diseases or inflammatory perfiric or CNS.
6.Pregnancy or breastfeeding.
7.Human Immunodeficiency Virus (HIV) seropositivity
8.History of other cancer, except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix.
9.Acute allergy or history of severe allergic reactions or autoimmune disease.
10.Patients on any other experimental product.
11.Patients who have been previously treated with comercial Rituximab
12.History of allergy to chemical or biologicl compounds similar to the experimental product.
13.Patients who have any decompensated concomitant disease, including but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, aortic stenosis, endocarditis and psychiatric illnesses that may limit adherence to the requirements of the test.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Response (complete remission (CR), unconfirmed complete response (Rcu) or partial remission (PR)). Measuring Time: at 6 weeks after four doses.<br>

Secondary Outcome Measures