CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Alemtuzumab +1 morebiological
Likely dose
Alemtuzumab 30 mg subcutaneously 3 days per week for 18 weeks; Rituximab 375 mg/m² intravenously every 2 weeks for 18 weeksAI-extracted
Key inclusion· 5
  • Diagnosis of B-cell CLL with peripheral blood absolute lymphocyte count >5,000/mm³
  • Small- to moderate-size lymphocytes with <55% prolymphocytes, atypical lymphocytes, or lymphoblasts
  • B-CLL phenotype expressing CD20 and CD52
  • B-cell shares B-cell antigens with CD5 in absence of pan-T-cell markers (CD-3, CD-2)
Key exclusion· 5
  • Active autoimmune anemia or thrombocytopenia
  • Active infection requiring oral or intravenous antibiotics
  • Second malignancy other than basal cell carcinoma of skin or in situ cervical carcinoma, unless curatively treated ≥2 years ago
  • Prior cytotoxic therapy (other than corticosteroids)

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

Search/NCT00858117
NCT00858117Phase 2Completed

A Phase II Trial of Alemtuzumab (Campath-1H) and Rituximab (Rituxan) in Patients With Previously Untreated CLL

Northwestern University·interventional·Posted Mar 9, 2009·Updated Nov 6, 2020

In Brief

A Phase 2 clinical trial evaluating Alemtuzumab and Rituximab for Leukemia. Completed, enrolled 30 participants across 1 site.

Detailed Summary

RATIONALE: Monoclonal antibodies, such as alemtuzumab and 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 alemtuzumab together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects of giving alemtuzumab together with rituximab and to see how well it works in treating patients with previously untreated B-cell chronic lymphocytic leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesUnited States
CollaboratorsBayer

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 9, 2009
Enrollment StartSep 26, 2005
Primary CompletionMar 17, 2010
Study CompletionJan 24, 2013
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 17.3 years ago

Interventions

Alemtuzumabbiological

Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks

Rituximabbiological

Rituximab administered intravenously at 375mg/m2 every 2 weeks for 18 weeks