Alemtuzumab and Rituximab in Treating Patients With High-Risk, Early-Stage Chronic Lymphocytic Leukemia

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT00436904
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Alemtuzumab — DRUG
    30 mg Monday, Wednesday, and Friday x 5 weeks
  • Rituximab — DRUG
    375mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)

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 and how well giving alemtuzumab together with rituximab works in treating patients with high-risk, early-stage chronic lymphocytic leukemia.

Key Dates

Start date
Dec 31, 2004
Status verified
Nov 2011
Primary completion
Jul 31, 2008
Completion
Nov 30, 2011

Study Design

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

Arms

  • Experimental: Alemtuzumab + Rituximab
    Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)

Primary Outcome Measure

Confirmed Response, Defined as Objective Complete Remission or Partial Remission for a Duration of at Least 2 Months [ Time Frame: Up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-

Find similar trials in Rochester, MN

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Mayo Clinic· Rochester, MN

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