Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 1

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

NCT00536341 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Fludarabine
  • DRUG Rituximab
  • DRUG lenalidomide

Study Locations (6)

Florida

  • Florida Cancer Specialists — Fort Myers
  • Florida Hospital Cancer Institute — Orlando

Maryland

  • Center for Cancer and Blood Disorders — Bethesda
  • National Capital Clinical Research Consortium — Bethesda

South Carolina

  • South Carolina Oncology Associates, PA — Columbia

Tennessee

  • Tennessee Oncology, PLLC — Nashville

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2008-01
Est. Completion 2016-11
Phase Phase 1

Sponsor

SCRI Development Innovations

63 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00536341

The ClinicalTrials.gov registry entry for NCT00536341 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SCRI Development Innovations, which has 63 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 3 interventions — of which Fludarabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00536341 reports 6 study locations spanning 4 distinct geographic areas — top geographies include Florida, Maryland, South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00536341 about?

NCT00536341 is a clinical study titled "Fludarabine, Rituximab, and Lenalidomide in Minimally Treated/Untreated Patients With Chronic Lymphocytic Leukemia (CLL)". 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)...

What is the current status of trial NCT00536341?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2008-01. Estimated completion is 2016-11.

What conditions does trial NCT00536341 study?

This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00536341?

The interventions under investigation include: Fludarabine (DRUG), Rituximab (DRUG), lenalidomide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00536341?

This trial is sponsored by SCRI Development Innovations, which has 63 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00536341 being conducted?

This trial has 6 study locations across Florida, Maryland, South Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial