Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT00280241
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Fludarabine — DRUG
    Fludarabine is usually administered by IV infusion over 30 minutes or longer.
  • Cyclophosphamide — DRUG
    The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.
  • Rituximab — DRUG
    First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated.

Study Details

This research study will look at the effects (good or bad) of administering cyclophosphamide, fludarabine, and rituximab. Clinical studies with combination therapy have shown higher response rates than using single drugs, and this study will evaluate the side effects and effectiveness of this combination.

Key Dates

Start date
Jun 30, 2004
Status verified
Jan 2016
Primary completion
Feb 29, 2008
Completion
Jan 31, 2013

Study Design

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

Arms

  • Experimental: FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB

Primary Outcome Measure

Tolerability of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL [ Time Frame: Duration of treatment on study ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hillman Cancer CenterPittsburghPennsylvania15232-

Find similar trials in Pittsburgh, PA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Hillman Cancer Center· Pittsburgh, PA

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