Alemtuzumab + Rituximab Consolidation in CLL

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00771602
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    375 mg/m\^2 by standard IV (intravenous) infusion on days 1, 8, 15, and 22 of weeks 1-4.
  • Alemtuzumab — DRUG
    Dose escalation of 3, 10 and 30 mg subcutaneously (SQ) during week 1, followed by dose of 30 mg subcutaneously three times weekly (e.g. Monday-Wednesday - Friday) starting on week 2 for a total of 12 weeks (2-13).

Study Details

The goal of this clinical research study is to find out how well Campath (alemtuzumab), Rituxan (rituximab), or a combination of the 2 drugs may control Chronic Lymphocytic Leukemia (CLL) that is left after chemotherapy. The safety of these drugs will also be studied.

Key Dates

Start date
Aug 31, 2008
Status verified
May 2015
Primary completion
Dec 31, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
1 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    Group 1: 375 mg/m\^2 IV Rituximab Alone
  • Experimental: Alemtuzumab
    Group 2: 30 mg SQ Alemtuzumab Alone
  • Experimental: Rituximab + Alemtuzumab
    Group 3: 375 mg/m\^2 Rituximab + 30 mg SQ Alemtuzumab

Primary Outcome Measure

Number of Patients With Molecular Remissions at 52 Weeks [ Time Frame: 52 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
UT MD Anderson Cancer Center· Houston, TX

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