CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
fludarabine phosphate +1 moredrug
Likely dose
Fludarabine phosphate IV and thalidomide orally (specific doses not stated)AI-extracted
Key inclusion· 7
  • Confirmed diagnosis of B-cell CLL with peripheral blood lymphocytosis >5,000/mm³
  • Co-expression of CD5, CD19 or CD20, and CD23 surface antigens
  • Clonal kappa or lambda light chain expression
  • Newly diagnosed (no prior CLL therapy)
Key exclusion· 6
  • Recurrent or refractory CLL
  • Other lymphoproliferative diseases or CLL transformation (e.g., prolymphocytic leukemia, Richter's syndrome)
  • Cardiac arrhythmia within past 6 months
  • Myocardial infarction within past 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00096018
NCT00096018Phase 2Completed

A Phase I/II Study of Fludarabine Plus Thalidomide as Frontline Therapy for Newly Diagnosed Patients With Chronic Lymphocytic Leukemia

Roswell Park Cancer Institute·interventional·Posted Nov 9, 2004·Updated Oct 24, 2013

In Brief

A Phase 2 clinical trial evaluating fludarabine phosphate and thalidomide for Leukemia. Completed, enrolled 43 participants across 1 site.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies such as thalidomide use different ways to stimulate the immune system and stop cancer cells from growing. Combining fludarabine with thalidomide may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of thalidomide when given together with fludarabine and to see how well they work in treating patients with newly diagnosed B-cell chronic lymphocytic leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 9, 2004
Enrollment StartMay 1, 2002
Primary CompletionNov 1, 2010
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 21.6 years ago

Interventions

fludarabine phosphatedrug

Given IV

thalidomidedrug

Orally