Campath-1H Plus Rituximab for CD52- and CD20- Positive Refractory or Relapsed Chronic Lymphoid Disorders

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00071396
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Campath-1H — DRUG
    15 mg/day Continuous infusion by vein (IV) for 6 days then given twice a week for remaining three weeks as 30 mg injection under skin to complete one treatment course of 4 weeks.
  • Rituximab — DRUG
    375 mg/m\^2 IV infusion on day 1, then 500 mg/m\^2 on days 8, 15, and 22.

Study Details

The goal of this clinical research study is to learn if giving CAMPATH-1H with rituximab can shrink or slow the growth of the disease in patients with chronic lymphoid disorders that have either not responded or whose disease has returned after treatment with standard therapies.

Key Dates

Start date
Oct 31, 2002
Status verified
Aug 2012
Primary completion
Sep 30, 2006
Completion
Aug 31, 2007

Study Design

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

Arms

  • Experimental: Campath-1H + Rituximab
    Campath 15 mg/day continuous intravenous (IV) infusion x 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course. Rituximab 375 mg/m\^2 IV infusion day 1, then 500 mg/m\^2 on days 8, 15 + 22.

Primary Outcome Measure

Overall Response [ Time Frame: After each 4 week course of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas - MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Texas - MD Anderson Cancer Center· Houston, TX

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