Efficacy/Safety Study of R-CHOP vs Bortezomib-R-CAP for Young Patients With Diffuse Large B-cell Lymphoma With Poor IPI.

Conditions

• Diffuse, Large B-Cell, Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Bortezomib — DRUG
  Bortezomib: subcutaneous, 1,3 mg/m2, day 1, 8, 15.
• Rituximab — DRUG
  Rituximab: intravenous, 375 mg/m2, day 1
• Cyclophosphamide — DRUG
  Cyclophosphamide: intravenous, 750 mg/m2, day 1
• Doxorubicin — DRUG
  Adriamycin:intravenous, 50 mg/m2, day 1
• Prednisone — DRUG
  Prednisone: oral, 100 mg, days 1-5
• Vincristine — DRUG
  Vincristine: intravenous, 1,4 mg/m2, day 1

Study Details

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 the patients will fail first line chemotherapy. The International Prognostic Index (IPI) score and the age adjusted IPI (aIPI) has been used since they were published to identify patients with different outcome. There is not standard therapy for young patients with DLBCL and unfavourable IPI score. The survival of these patients remains poor, with EFS around 40%. The combination of RCHOP with new drugs is an attractive approach to treat these patients. The goal is to evaluate the proportion of patients with Event-Free Survival (EFS) after 2 years, with a diagnosis of DLBCL with an aIPI \> 1 or an aIPI =1 with increased levels of beta-2-microglobulin (above the Upper Limits of Normal.)

Key Dates

Start date

Oct 3, 2013

Status verified

Sep 2018

Primary completion

Jan 31, 2018

Completion

Aug 31, 2018

Study Design

Enrollment

121 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: R-CHOP
  6 cycles every 21 days. * Rituximab: intravenous, 375 mg/m2, day 1 * Cyclophosphamide: intravenous, 750 mg/m2, day 1 * Doxorubicin: intravenous, 50 mg/m2, day 1 * Vincristine: intravenous, 1,4 mg/m2, day 1 * Prednisone: oral, 100 mg, days 1-5
• Experimental: B-R-CAP
  6 cycles every 21 days * Bortezomib: subcutaneous, 1,3 mg/m2, day 1, 8, 15 * Rituximab: intravenous, 375 mg/m2, day 1 * Cyclophosphamide: intravenous, 750 mg/m2, day 1 * Doxorubicin: intravenous, 50 mg/m2, day 1 * Prednisone: oral, 100 mg, days 1-5

Primary Outcome Measure

Proportion of patients with Event-Free Survival at 2 years. [ Time Frame: During treatment period, there will be assessments every 2 cycles. After end of treatment every 3 month the first year, every 6 months the second year and annually from 3rd to 5th year ]