CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Alemtuzumab +2 moredrug
Likely dose
Alemtuzumab 3-30 mg IV; Fludarabine and Cyclophosphamide (specific doses not stated)AI-extracted
Key inclusion· 7
  • ✓Age ≥18 years
  • ✓Karnofsky performance status ≥60%
  • ✓Confirmed immunohistological diagnosis of CLL
  • ✓Advanced stage disease (Rai Stage III-IV) OR Rai Stage I-II with NCI criteria for active disease (including symptoms, marrow failure, autoimmune cytopenias, massive/progressive splenomegaly, bulky/progressive lymphadenopathy, or progressive lymphocytosis)
Key exclusion· 7
  • ✕Prior pharmacological treatment for CLL
  • ✕History of anaphylaxis following monoclonal antibody exposure
  • ✕Active secondary malignancy or malignant disease history (other than CLL or non-melanoma skin cancer) within 5 years
  • ✕Any medical condition requiring systemic corticosteroids

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

Search/NCT00230282
NCT00230282Phase 2Completed
CompareCT.gov

A Multi-Center Phase 2 Efficacy and Pharmacokinetic Study Evaluating Fludarabine, Cyclophosphamide, and Subcutaneous Campath (FCCam, Alemtuzumab) for Previously Untreated B-Cell Chronic Lymphocytic Leukemia

Steven E. Coutre·interventional·Posted Sep 30, 2005·Updated Oct 6, 2014

In Brief

A Phase 2 clinical trial evaluating Alemtuzumab, Fludarabine, and 1 other intervention for Leukemia and 3 related conditions. Completed, enrolled 25 participants across 1 site.

Detailed Summary

The primary objective of this study was to evaluate the safety and efficacy of the combination of fludarabine and cyclophosphamide in previously untreated CLL patients. Participants will receive fludarabine and cyclophosphamide on days 1, 2, and 3 of six 28-day cycles.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, B-cell Leukemia, Chronic Leukemia, Chronic Lymphocytic Leukemia (CLL)
CountriesUnited States
CollaboratorsBayer

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 30, 2005
Enrollment StartJul 1, 2004
Primary CompletionDec 1, 2010
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 20.8 years ago

Interventions

Alemtuzumabdrug

3 to 30 mg, IV

Fludarabinedrug

\[(2R,3R,4S,5R)-5-(6-amino-2-fluoro-purin-9-yl)- 3,4-dihydroxy-oxolan-2-yl\]methoxyphosphonic acid

Cytoxandrug

(RS)-N,N-bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-amine 2-oxide