MLN4924 Compared With MLN4924 Plus Chemotherapy for Large B-cell Lymphoma

Conditions

• Diffuse, Large B-cell Lymphoma
• Large-Cell Lymphoma, Diffuse
• Lymphoma, Diffuse Large-Cell
• Lymphoma, Diffuse Large-Cell B-cell

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• MLN4924 — DRUG
  Part A: 150mg/m2 IV (in the vein) on days 1,4,7,11 of each 21 day cycle Part B: variable dose levels IV on days 1,5 each 21 day cycle
• Etoposide — DRUG
  CIV(continuous intravenous infusion) on days 1-4 of every 21 day cycle
• Prednisone — DRUG
  PO (by mouth) twice daily on days 1-5 of every 21 day cycle
• Vincristine — DRUG
  CIV on days 1-4 of every 21 day cycle
• Cyclophosphamide — DRUG
  IV on day 5 of each 21 day cycle
• Doxorubicin — DRUG
  CIV on days 1-4 of each 21 day cycle
• Rituximab — DRUG
  IV on day 1 of each 21 day cycle
• Filgrastim — DRUG
  Subcutaneously beginning Day 6 of each 21 day cycle

Study Details

Background: \- MLN4924 is an experimental cancer drug. It may help kill lymphoma cells and make them more sensitive to chemotherapy. EPOCH R is a combination chemotherapy drug. It has been effective in treating some cases of large B-cell lymphoma. This research will look at two things. The first is the effect of MLN4924 on its own in treating large B-cell lymphoma. The second is the safe dose and effect of MLN4924 and EPOCH-R in combination when treating large B-cell lymphoma. Objectives: * To study how MLN4924 affects large B-cell lymphoma tumors. * To compare the effects of MLN 4924 alone and MLN4924 plus standard EPOCH-R chemotherapy. Eligibility: \- Individuals at least 18 years of age who have large B-cell lymphoma that will be treated with chemotherapy. Design: * Participants will be screened with a medical history and physical exam. They will also have blood and urine tests, tumor samples, and imaging studies. * Participants will receive MLN4924 for a maximum of six 21-day cycles of treatment. Each cycle involves a dose of MLN4924 twice a week for 2 weeks, followed by a 1-week rest period. Participants will be monitored with frequent blood tests and imaging studies. * Participants who do not benefit from MLN4924 alone will have MLN4924 along with EPOCH-R chemotherapy for up to six cycles of treatment.

Key Dates

Start date

Jul 15, 2011

Status verified

Jan 2014

Primary completion

Jan 7, 2014

Completion

Jan 7, 2014

Study Design

Enrollment

0 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Primary Outcome Measure

Assess response of MLN4924 in relapsed/refractory DLBCL [ Time Frame: 4 years ]