CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 877 enrolled
Drug / intervention
Fludarabinedrug
Likely dose
Fludarabine 25 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00262782
NCT00262782Phase 3Completed
CompareCT.gov

Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia

German CLL Study Group·interventional·Posted Dec 7, 2005·Updated Feb 20, 2020

In Brief

A Phase 3 clinical trial evaluating Fludarabine for Chronic Lymphocytic Leukemia. Completed, enrolled 877 participants across 117 sites in 2 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sometimes, the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether fludarabine is more effective than observation in treating chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works compared to observation only in treating patients with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia
CountriesAustria, Germany
Collaborators--

Timeline

Phase 3CompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 7, 2005
Enrollment StartApr 1, 1997
Primary CompletionDec 1, 2004
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 20.6 years ago

Interventions

Fludarabinedrug

Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles