Status:
COMPLETED
Efficacy/Safety Study of R-CHOP vs Bortezomib-R-CAP for Young Patients With Diffuse Large B-cell Lymphoma With Poor IPI.
Lead Sponsor:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Collaborating Sponsors:
Janssen-Cilag, S.A.
Conditions:
Diffuse, Large B-Cell, Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Diffuse large B cell lymphoma (DLBCL) is the most common non-Hodgkin's lymphoma, accounting for between 30% and 50% of the patients. Although it is considered a curable disease, still at least 40 % of...
Detailed Description
Diffuse large B cell lymphoma (DLBCL) is the most common non-Hodgkin's lymphoma, accounting for between 30% and 50% of the patients. Although it is considered a curable disease, still at least 40 % of...
Eligibility Criteria
Inclusion
- Patients diagnosed with primary diffuse DLBCL who have never received treatment for this condition.
- Age between 18 and 70 years.
- Age-adjusted IPI (aIPI) higher than 1, or equal 1 with high levels of beta-2-microglobulin (above UNL)
- Cluster of Differentiation 20 (CD20) positive b lymphocytes.
- Eastern Cooperative Oncology Group (ECOG) 0-3.
- More than 12 weeks of life expectancy.
- Signed Informed Consent.
- 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.
Exclusion
- Pregnant women or in breast-feeding period, or adults in childbearing period not using an effective contraception method.
- Patients with Central Nervous System (CNS) lymphoma.
- Severely impaired renal function (creatinine\> 2.5 UNL) or hepatic function impairment (bilirubin or Alanine Amino Transaminase (ALT) / Aspartate Aminotransferase (AST) \> 3 UNL), unless it is suspected to be due to the disease.
- Human immunodeficiency virus (HIV) positive patients
- Patient previously treated for the DLBCL
- Positive determination of chronic hepatitis B (defined as positive serology for HBsAg). It will be allowed to enroll patients with hidden or previous hepatitis B (defined as positive antibodies against the core of the hepatitis B virus \[HBcAb\] and HBsAg negative) if undetectable Hepatitis B Virus (HBV) DNA.
- Positive results for hepatitis C (antibody serology for hepatitis C virus ((HCV)). Patients with HCV positive may only participate if the Polymerase Chain Reaction (PCR) result is negative for HCV RNA.
- History of cardiovascular disease with ventricular ejection fraction \< 50%.
- Patients with severe psychiatric conditions that may interfere with their ability to understand the study (including alcoholism or drug addiction).
- Patients with known hypersensitivity to murine proteins or any other components of the study drugs.
- Transformed follicular lymphoma.
- History of other neoplastic malignancy with \< 5 year of complete response (except for Squamous Cell Carcinoma of the Skin or cervical Carcinoma in situ).
- Presence of uncontrolled conditions: cardiac, respiratory, neurologic, metabolic etc., not related to lymphoma.
- Uncontrolled hypertension (diastolic blood pressure over 110 mmHg).
Key Trial Info
Start Date :
October 3 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01848132
Start Date
October 3 2013
End Date
August 1 2018
Last Update
September 19 2018
Active Locations (21)
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1
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragon, Spain, 50009
2
Hospital Son Llàtzer
Palma, Balearic Islands, Spain, 07198
3
Institut Català d'Oncologia, Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
4
Institut Català d'Oncologia, Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain, 08908