Fludarabine, Rituximab, and Lenalidomide in Minimally Treated/Untreated Patients With Chronic Lymphocytic Leukemia (CLL)

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00536341
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • lenalidomide — DRUG
    2.5 mg orally (PO) daily, Days 8-28, Cycle 1; 5.0 mg PO daily, Days 8-28 Cycles 2-6
  • Rituximab — DRUG
    375 mg/m2 Cycle 1 (split over Day 1 \& Day 2); 500 mg/m2 Day 1 of Cycles 2-6
  • Fludarabine — DRUG
    25 mg/m2 on Days 1, 2, and 3

Study Details

This phase I/II trial will combine fludarabine, rituximab, and lenalidomide in untreated or minimally treated (Phase I only) CLL patients, employing fixed doses of fludarabine and rituximab, using a schedule similar to that examined by investigators at MD Anderson (J Clin Oncol 23(18):4079-88, 2005). Given that the optimal dose and schedule is not currently known, this trial will perform a phase I component followed by a phase II examination to further explore this regimen's activity.

Key Dates

Start date
Jan 31, 2008
Status verified
Nov 2016
Primary completion
Apr 30, 2013
Completion
Nov 30, 2016

Study Design

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

Arms

  • Experimental: lenalidomide, fludarabine, rituximab
    Phase I Non-stratified, dose-escalation: \>=3 patients per dose level. Safety and tolerability will be evaluated every 2 weeks during the active treatment. Doses of lenalidomide will be escalated, while the fludarabine and rituximab doses remain fixed. Phase II The Phase II regimen will be chosen following a review of the Phase I data. Following selection of the Phase II schedule, 40 treatment naive patients will be enrolled and treated with the Phase II regimen every 28 days for up to 6 courses. For those patients achieving a CR after 3 cycles, one additional cycle of treatment will be administered beyond CR confirmation.

Primary Outcome Measure

Number of Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 63 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsFort MyersFlorida33901-
Florida Hospital Cancer InstituteOrlandoFlorida32804-
Center for Cancer and Blood DisordersBethesdaMaryland20817-
National Capital Clinical Research ConsortiumBethesdaMaryland20817-
South Carolina Oncology Associates, PAColumbiaSouth Carolina29210-
Tennessee Oncology, PLLCNashvilleTennessee37023-

Find similar trials in Fort Myers, FL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Florida Cancer Specialists· Fort Myers, FLFlorida Hospital Cancer Institute· Orlando, FLCenter for Cancer and Blood Disorders· Bethesda, MDNational Capital Clinical Research Consortium· Bethesda, MDSouth Carolina Oncology Associates, PA· Columbia, SCTennessee Oncology, PLLC· Nashville, TN

Related Studies