S0601 Rituximab, Combination Chemotherapy, and Bortezomib Followed by Bortezomib Alone in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

Conditions

• Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• rituximab — BIOLOGICAL
  375 mg/m\^2 on day 1 for cycles 1-6.
• bortezomib — DRUG
  1.3 mg/m\^2 on days 1, 4 of cycles 1-6 and on days 1, 4, 8, 11 of cycles 7-14.
• cyclophosphamide — DRUG
  750 mg/m\^2 on day 1 of cycles 1-6.
• doxorubicin hydrochloride — DRUG
  50 mg/m\^2 on day 1 of cycles 1-6.
• prednisone — DRUG
  100 mg on days 1-5 of cycles 1-6.
• vincristine sulfate — DRUG
  1.4 mg/m\^2 on day 1 of cycles 1-6.

Study Details

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and bortezomib may kill more cancer cells. Giving bortezomib as maintenance therapy may keep the cancer from progressing. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy and bortezomib followed by bortezomib alone works in treating patients with newly diagnosed mantle cell lymphoma.

Key Dates

Start date

Aug 31, 2006

Status verified

Oct 2017

Primary completion

Dec 31, 2012

Completion

Sep 30, 2017

Study Design

Enrollment

68 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: R-CHOP + Velcade
  6 21-day cycles of standard R-CHOP with 1.3 mg/m\^2 Bortezomib given on days 1 and 4 of each cycle. This is followed by 8 3-month cycles of maintenance with 1.3 mg/m\^2 Bortezomib on days 1, 4, 8 and 11 of each cycle.

Primary Outcome Measure

2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM) [ Time Frame: 0-2 years ]

Locations (147)

Find similar trials in Anchorage, AK

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