Randomized phase II study of treatment with R-CHOP vs Bortezomib-R-CAP for young patients with poor IPI diffuse large B-cell lymphoma.

Phase 1

• Conditions: Diffuse large B cell lymphoma (DLBCL); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]; MedDRA version: 14.1Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disorders

• Registration Number: EUCTR2012-005138-12-ES
• Lead Sponsor: GELTAMO (Grupo Cooperativo Español de Linfoma/Trasplante Autólogo de Médula Ósea)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-09
• Last Update Posted: 1 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

1.- Patients diagnosed with primary diffuse DLBCL who have never received treatment for this condition.
2.- Age between 18 and 70 years.
3.- Age adjusted IPI higher than 1 or equal 1, with high levels of beta-2-microglobulin (above UNL)
4.- Neoplasic B lymphocytes for CD20 positivity.
5.- ECOG 0-3
6.- More than 12 weeks of life expectancy.
7.- Signed Informed Consent.
8.- Nor pregnant women nor breast-feeding women without heterosexual activity during the entire study. Women with heterosexual activity only if they are willing to use two methods of contraceptive. The two contraceptive methods can be, two barrier method or a barrier method combinated with an hormonal contraceptive method to prevent pregnancy, used during the entire study and until 3 months after the study completion.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 127
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 127

Exclusion Criteria

1. Pregnant women or in breast-feeding period, or adults in childbearing period not using an effective contraception method.
2. Patients with CNS lymphoma
3. Patients with severe impairment of renal function (creatinine> 2.5 UNL) or hepatic (bilirubin or ALT / AST> 3 UNL), unless it is suspected to be due to the disease.
4. HIV positive patients
5. Patient previously treated for the DLBCL
6. Positive determination of chronic hepatitis B (defined as positive serology for HBsAg). It will be allowed to enroll patients with hidden or previuos hepatitis (defined as positive antibodies against the core of the hepatitis B virus [HBcAb] and HBsAg negative) if undetectable HBV DNA.
7. Positive results for hepatitis C (antibody serology for hepatitis C virus [HCV]). Patients with HCV positive may participate only if the result of the PCR is negative for HCV RNA.
8.Patients with previous history of cardiac disease: ventricular ejection fraction < 50%.
9. Patients with severe psiquiatric conditions that may interfere with their ability to understand the study (including alcoholism or drug addiction).
10. Patients with known hypersensitivity to murine proteins or any other component of the study drugs.
11. Transformed follicular lymphoma.
12. History of other primary malignancy with < 5 year of complete response (except for basal or squamous cell carcinomas of the skin or cervical carcinoma in situ).
13. Uncontrolled current illness: cardiac, pulmonary, neurologic, metabolic etc, not related to lymphoma.
14. Uncontrolled hypertension (diastolic blood pressure over 110 mmHg).
15. Psychiatric illnesses that could compromise the patient participation in the study.
16. Known or suspected hypersensitivity to any of the agents of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified