Fludarabine, Cyclophosphamide, and Rituximab Versus Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia Patients

Part of paid clinical trials in Ocoee, Florida.

Sponsor
US Oncology Research
Study ID
NCT00254163
Phase
PHASE3
Status
Completed

Conditions

  • B-Cell Chronic Lymphocytic Leukemia

Eligibility Criteria

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

Interventions

  • Fludarabine — DRUG
  • Cyclophosphamide — DRUG
  • Rituximab — DRUG
  • Pentostatin — DRUG

Study Details

The purpose of this research study is to find out what effects (good and bad) the combination of Nipent+Cytoxan+Rituxan has on CLL cancer compared to Fludara+Cytoxan+Rituxan. While all of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of other cancers, these combinations are experimental for the treatment of CLL.

Key Dates

Start date
Dec 31, 2003
Status verified
Sep 2016
Primary completion
Sep 30, 2011
Completion
Sep 30, 2011

Study Design

Enrollment
184 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Fludarabine, Cyclophosphamide, and Rituximab
    Fludarabine, Cyclophosphamide, and Rituximab (dosage based on day in cycle)
  • Experimental: Pentostatin, Cyclophosphamide, and Rituximab
    Pentostatin, Cyclophosphamide, and Rituximab (dosage depends on day in cycle)

Primary Outcome Measure

Infection Rate [ Time Frame: 6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity ]

Locations (11)

FacilityCityStateZIPSite coordinators
Cancer Centers of Florida, P.A.OcoeeFlorida34761-
Hope CenterTerre HauteIndiana47802-
Alliance Hematology Oncology PAWestminsterMaryland21157-
St Joseph Oncology, IncSaint JosephMissouri64507-
New York Oncology Hematology, PCAlbanyNew York12208-
Northwestern Carolina Oncology HematoHickoryNorth Carolina28602-
Medical Oncology AssociatesKingstonPennsylvania18704-
South Texas Cancer Center-McAllenMcAllenTexas78503-
Texas Oncology Cancer Center-Sugar LandSugar LandTexas77479-
Cancer Care Northwest-SouthSpokaneWashington99202-
Yakima Valley Mem Hosp/North Star LodgeYakimaWashington98902-

Find similar trials in Ocoee, FL

By research site
Cancer Centers of Florida, P.A.· Ocoee, FLHope Center· Terre Haute, INAlliance Hematology Oncology PA· Westminster, MDSt Joseph Oncology, Inc· Saint Joseph, MONew York Oncology Hematology, PC· Albany, NYNorthwestern Carolina Oncology Hemato· Hickory, NC

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