A Phase II Trial of Alemtuzumab and Rituximab in Patients With Previously Untreated CLL

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT00858117
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alemtuzumab — BIOLOGICAL
    Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks
  • Rituximab — BIOLOGICAL
    Rituximab administered intravenously at 375mg/m2 every 2 weeks for 18 weeks

Study Details

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.

Key Dates

Start date
Sep 26, 2005
Status verified
Oct 2020
Primary completion
Mar 17, 2010
Completion
Jan 24, 2013

Study Design

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

Arms

  • Experimental: Alemtuzumab and Rituximab
    Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia.

Primary Outcome Measure

Number of Patients Treated With Alemtuzumab and Rituximab Combination With a Response (CR or PR) Assessed by NCI-WG 1996 Criteria With Lymph-adenopathy and Organomegaly Measured During Physical Examination [ Time Frame: At week 9, and post-18 weeks then every 3 months for a year and up every 6 months for up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern University, Northwestern Medical Faculty FoundationChicagoIllinois60611-

Find similar trials in Chicago, IL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Northwestern University, Northwestern Medical Faculty Foundation· Chicago, IL

Related Studies