CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 86 enrolled
Drug / intervention
Fludarabine +6 moredrug
Likely dose
Not stated in 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/NCT00462332
NCT00462332Phase 2Completed

Phase II Pilot Trial to Evaluate the Efficacy of a Combined Therapy Approach for Young CLL Patients With Advanced and Progressive Disease Stratified According to the Biological Prognostic Features

Gruppo Italiano Malattie EMatologiche dell'Adulto·interventional·Posted Apr 19, 2007·Updated Sep 6, 2013

In Brief

A Phase 2 clinical trial evaluating Fludarabine, Campath, and 1 other intervention for Leukemia. Completed, enrolled 86 participants across 23 sites.

Detailed 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 alemtuzumab, 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. A peripheral stem cell transplant using stem cells from the patient or a donor may replace the patient's immune cells that were destroyed by chemotherapy. PURPOSE: This phase II trial is studying how well giving fludarabine together with alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplant or alemtuzumab works in treating patients with advanced or progressive chronic lymphocytic leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesItaly
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 19, 2007
Enrollment StartMay 1, 2007
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 19.2 years ago

Interventions

Fludarabinedrug

Induction therapy

Campathdrug

Induction therapy

Transplantprocedure

Post-induction therapy

Campathdrug

Post-induction therapy

Fludarabinedrug

Induction therapy

Campathdrug

Induction therapy

Campathdrug

Post-induction therapy