Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL

Part of paid clinical trials in Green Bay, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT00974233
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bendamustine — DRUG
    90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles
  • Rituximab — DRUG
    375 mg/m2 Day 1 every 28 days for 6 cycles
  • Lenalidomide — DRUG
    5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol.

Study Details

The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.

Key Dates

Start date
Oct 31, 2009
Status verified
Jul 2017
Primary completion
Jul 31, 2013
Completion
Apr 30, 2015

Study Design

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

Arms

  • Experimental: Induction/Maintenance chemotherapy
    Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy

Primary Outcome Measure

Progression Free Survival [ Time Frame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up) ]

Locations (10)

FacilityCityStateZIPSite coordinators
Bellin Memorial HospitalGreen BayWisconsin54313-
St Vincent Regional Cancer CenterGreen BayWisconsin54301-
Mercy Health System Heme/OncJanesvilleWisconsin53548-
Gundersen ClinicLa CrosseWisconsin54601-
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792-
Marshfield ClinicMarshfieldWisconsin54449-
Medical College of WisconsinMilwaukeeWisconsin53226-
Oconomowoc Memorial HospitalOconomowocWisconsin53066-
Waukesha Memorial HospitalWaukeshaWisconsin53188-
Riverview HospitalWisconsin RapidsWisconsin54494-

Find similar trials in Green Bay, WI

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By specialty
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By research site
Bellin Memorial Hospital· Green Bay, WISt Vincent Regional Cancer Center· Green Bay, WIMercy Health System Heme/Onc· Janesville, WIGundersen Clinic· La Crosse, WIUniversity of Wisconsin Carbone Cancer Center· Madison, WIMarshfield Clinic· Marshfield, WI

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