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

Sponsor
Cancer Trials Ireland
Study ID
NCT00812669
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
0 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • pegfilgrastim — BIOLOGICAL
  • rituximab — BIOLOGICAL
  • cyclophosphamide — DRUG
  • fludarabine phosphate — DRUG
  • cytogenetic analysis — GENETIC
  • fluorescence in situ hybridization — GENETIC
  • gene expression analysis — GENETIC
  • mutation analysis — GENETIC
  • protein expression analysis — GENETIC
  • flow cytometry — OTHER
  • laboratory biomarker analysis — OTHER

Study Details

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.

Key Dates

Start date
Aug 18, 2008
Status verified
Jul 2025
Primary completion
Nov 21, 2019
Completion
Nov 21, 2019

Study Design

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

Arms

  • Experimental: Fludarabine, Cylophosphamide and Rituximab

Primary Outcome Measure

Complete remission rate by NCI response criteria and minimal residual disease (MRD) analysis [ Time Frame: A formal assessment of response by NCI Criteria (Appendix 3) with the addition of assessment of minimal residual disease in the marrow and if relevant assessment of bulky disease by CT scanning will be made after 4 +/-6 courses of therapy. ]

Related Studies