MedTrace Logo

CLL-Irl Study. CTRIAL-IE (ICORG) 07-01, V7

NCT00812669 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-07-08

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving fludarabine together with cyclophosphamide and rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying giving fludarabine together with cyclophosphamide and rituximab to see how well it works in treating patients with chronic lymphocytic leukemia.

Conditions

Interventions

BIOLOGICAL

pegfilgrastim

BIOLOGICAL

rituximab

DRUG

cyclophosphamide

DRUG

fludarabine phosphate

GENETIC

cytogenetic analysis

GENETIC

fluorescence in situ hybridization

GENETIC

gene expression analysis

GENETIC

mutation analysis

GENETIC

protein expression analysis

OTHER

flow cytometry

OTHER

laboratory biomarker analysis

Sponsors & Collaborators

  • Cancer Trials Ireland

    lead NETWORK

Principal Investigators

  • Elisabeth Vandenberghe, MD · St. James's Hospital, Ireland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-18
Primary Completion
2019-11-21
Completion
2019-11-21

Countries

  • Ireland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00812669 on ClinicalTrials.gov