A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Aggressive B-cell Lymphoma: NHL-13

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 9

Inclusion Criteria

1. Have received eight infusions of rituximab plus 4-8 cycles of chemotherapy similar to CHOP as first-line therapy for NHL.
2. The induction treatment will conclude with the application of the final cycle of chemotherapy or immunotherapy of no more than 12 weeks and not less than 4 weeks before starting the therapeutic trial.
3. Patients will have achieved complete remission (CR) or unconfirmed CR (RCu) after induction treatment for remission.
4. Histological diagnosis of diffuse large B-cell lymphoma (DLBCL) or grade 3b follicular lymphoma.
5. Confirmed positivity to GD20 of the lymphoma at the time of diagnosis.
6. ECOG performance status of 0, 1 or 2 at the time of being included.
7. IPI known at the time of diagnosis.
8. 18 years of age or older.
9. Life expectancy of at least 3 months.
10. Disposition and capacity to comply with the study protocol.
11. Women of reproductive age should have a negative pregnancy test and accept the use of effective contraceptives throughout the treatment period and 12 months later.
12. Have informed consent of patients.

Exclusion Criteria

1. Therapy for first-line NHL other than that specified in the inclusion criteria.
2. More than one previous chemotherapy regimen.
3. Histology other than DLBCL and grade 3b follicular lymphoma.
4. Presence of transformed lymphoma.
5. History of tumor other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix in the last 5 years.
6. Major surgery, different from diagnostic surgery, in the last 4 weeks.
7. Evidence of CNS affection. Patients with a history of uncontrollable seizures, central nervous system disorders or psychiatric disorders that the researcher deems clinically significant and that may adversely affect compliance with the administration of the drugs under study.
8. Presence of clinically significant heart disease or myocardial infarction in the last 6 months.
9. Hematological alterations in the baseline studies requested at the start of the study with values below normal in any of the following parameters: leukocytes, absolute neutrophil count and platelets.
10 Abnormalities in liver function tests.
11. Renal insufficiency.
12. Patients with active opportunistic infections.
13. HIV-positive patients.
14. Intolerance to rituximab.
15. Active viral hepatitis, specifically HBV or HCV infection.
16. Severe underlying conditions that may impair the patient´s ability to participate in the trial.
17. Life expectancy <6 months.
18. Sensitivity or known allergy to products of murine origin.
19. Treatment in a clinical trial in the 30 days prior to entering this study.
20. The transformed form.
21. Women in the lactation stage, who do not use effective contraception, are pregnant or refuse not to get pregnant during the therapeutic trial phase and for 12 months thereafter. Men who refuse not to father a child during the treatment phase and 2 months thereafter.
22. Patients under guardianship.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical evaluation, in which the time from the beginning of the therapy to the appearance of an event will be determined. An event is defined as: progression, relapse (according to the criteria of Cheson et al.), Death from any cause, initiation of a new antilinfoma treatment, secondary malignancy or unacceptable toxicity.<br>Measure:Event free survival (EFS).<br>Timepoints:When the event is presented.<br>

Secondary Outcome Measures

Name	Time	Method