Rituximab, Alemtuzumab, and GM-CSF As First-Line Therapy in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT00562328
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Alemtuzumab — BIOLOGICAL
    Week 1 (dose escalation): Day 3: 3mg subcutaneously; Day 4: 10mg subcutaneously; Day 5 30mg subcutaneously Weeks 2-5: 30mg subcutaneously three times a week.
  • Rituximab — BIOLOGICAL
    Weeks 2-5: 375 mg/m\^2 by IV once weekly
  • Sargramostim — BIOLOGICAL
    Week 1-6: 250 mcg subcutaneously three time as week

Study Details

RATIONALE: Monoclonal antibodies, such as rituximab and alemtuzumab, 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. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving monoclonal antibody therapy together with GM-CSF may be an effective treatment for early-stage chronic lymphocytic leukemia. PURPOSE: This phase II trial is studying the side effects of giving rituximab and alemtuzumab together with GM-CSF and to see how well it works in treating patients with early-stage chronic lymphocytic leukemia.

Key Dates

Start date
Jan 31, 2008
Status verified
May 2017
Primary completion
Feb 5, 2010
Completion
Dec 18, 2014

Study Design

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

Arms

  • Experimental: Alemtuzumab + Rituximab + GM-CSF
    Alemtuzumab + Rituximab + GM-CSF

Primary Outcome Measure

Number of Confirmed Responses (Complete or Partial Response Noted as the Objective Status for a Duration of at Least 2 Months) at 6 Months [ Time Frame: 6 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic ScottsdaleScottsdaleArizona85259-5499-
Mayo Clinic Cancer CenterRochesterMinnesota55905-

Find similar trials in Scottsdale, AZ

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

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