Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT00581776
Phase
PHASE2
Status
Completed

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bortezomib — DRUG
    Administered by IV at 1.3 mg/m2 days 1 and 4 of each 21 day cycle.
  • Rituximab — DRUG
    Administered by IV 375 mg/m2 IV day 1 of each cycle during induction chemotherapy, then weekly for four weeks during consolidation therapy; and then once every 12 weeks for up to 5 years (or until disease progression).
  • Cyclophosphamide — DRUG
    Administered by IV at 300 mg/m2, 6 doses spaced 12 hours apart on days 1-3 of each cycle, to start after completion of rituximab infusion
  • Doxorubicin — DRUG
    Given as a continuous infusion, 50 mg/m2 over 48 hours days 1-2 of each cycle, to start after completion of rituximab infusion.
  • Vincristine — DRUG
    1 mg administered by IV on day 3 of each cycle.
  • Dexamethasone — DRUG
    40 mg orally on days 1-4 of each cycle.

Study Details

Patients will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x 4) , then one dose of rituximab every 12 weeks until 5 years or disease progression.

Key Dates

Start date
May 31, 2005
Status verified
May 2016
Primary completion
Nov 30, 2012
Completion
May 31, 2015

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VCR-CVAD with rituximab maintenance
    Induction chemotherapy with Bortezomib, cyclophosphamide, rituximab, vincristine, doxorubicin, and dexamethasone. Subjects will receive 6 cycles of induction chemotherapy, of 21 days each. After completing induction, subjects will receive rituximab consolidation (4 weeks), and then rituximab maintenance therapy for up to 5 years.

Primary Outcome Measure

Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR). [ Time Frame: At completion of induction therapy (21 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University Of Wisconsin Cancer CenterMadisonWisconsin53792-

Find similar trials in Madison, WI

By research site
University Of Wisconsin Cancer Center· Madison, WI

Related Studies