Fludarabine Combined With Either Alemtuzumab or Rituximab in Treating Patients With Refractory or Relapsed B-Cell Chronic Lymphocytic Leukemia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Bayer
Study ID
NCT00086775
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • alemtuzumab — BIOLOGICAL
  • rituximab — BIOLOGICAL
  • fludarabine phosphate — DRUG

Study Details

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as alemtuzumab and rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells. It is not yet known whether fludarabine is more effective when combined with alemtuzumab or with rituximab in treating chronic lymphocytic leukemia. PURPOSE: Randomized phase II trial to compare the effectiveness of combining fludarabine with either alemtuzumab or rituximab in treating patients who have refractory or relapsed B-cell chronic lymphocytic leukemia.

Key Dates

Start date
Jul 31, 2003
Status verified
Oct 2009
Primary completion
Jun 30, 2005
Completion
Oct 31, 2009

Study Design

Allocation
RANDOMIZED
Primary purpose
TREATMENT

Locations (5)

FacilityCityStateZIPSite coordinators
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBostonMassachusetts02115-
Jackson Oncology Associates, PLLCJacksonMississippi39202-
Cancer Institute of New Jersey at Robert Wood Johnson University HospitalNew BrunswickNew Jersey08903-
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburghPennsylvania15232-
Western Pennsylvania Cancer InstitutePittsburghPennsylvania15224-

Find similar trials in Boston, MA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute· Boston, MAJackson Oncology Associates, PLLC· Jackson, MSCancer Institute of New Jersey at Robert Wood Johnson University Hospital· New Brunswick, NJHillman Cancer Center at University of Pittsburgh Cancer Institute· Pittsburgh, PAWestern Pennsylvania Cancer Institute· Pittsburgh, PA

Related Studies