Clinical trial NCT00206726: Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
Official title: Phase II Study Using Alemtuzumab Combined With Fludarabine for the Treatment of Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL) patients who have received at least one prior therapy.

Treatments will be administered on a 28-day cycle for 4-6 cycles, with an evaluation during Cycle 4 to permit re-staging. Alemtuzumab and fludarabine will be administered on Days 1-5 of each cycle. Patients will be assessed for response at the time of re-staging at Cycle 4 and at the end of Cycle 6. At the time of the re-staging, patients achieving a Partial Remission (PR) or Stable Disease (SD) will be given an additional 2 cycles of treatment and patients demonstrating presumptive signs of a Complete Remission (CR) will receive no further treatment but will be followed for response.

Detailed description: As of April, 2011 Bayer transferred this record to Genzyme. Genzyme is now the sponsor of this trial. NOTE: This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Eligibility criteria: Inclusion Criteria:

* Patient must have confirmed B-CLL.
* Patients must have received at least one prior therapy and must require treatment for active disease

Exclusion Criteria:

* Treatment with any anti-cancer agents (chemotherapies, monoclonal antibodies, etc) within 4 weeks of start of study.
* History of significant allergic reaction to antibody therapies that required discontinuation of antibody therapy
* History of human immunodeficiency virus (HIV) positivity.
* Active infection requiring treatment
* Pregnancy or lactation
* Other severe, concurrent diseases or mental disorders
* Central nervous system involvement of chronic lymphocytic leukemia (CLL)

Primary outcomes:
measure: Complete Response (CR)
timeFrame: 28 days after last cycle with confirmation 2 months later
Secondary outcomes:
measure: Overall Response (OR)
timeFrame: 28 days after last cycle with confirmation 2 months later
measure: Overall Survival (OS)
timeFrame: 1 year after start of treatment
measure: Progression-free Survival (PFS)
timeFrame: 1 year after start of treatment
measure: Percentage of Participants With Overall Response at Different Observation Times
timeFrame: from first date of confirmed response until relapse, or death, or study data cutoff date, whichever is earlier
measure: Number of Participants With Minimal Residual Disease (MRD)
timeFrame: When CR is confirmed
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Berkeley
country: United States
state: California
city: Burbank
country: United States
state: California
city: Concord
country: United States
state: California
city: Stanford
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Lakeland
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Aurora
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Metairie
country: United States
state: Louisiana
city: Clinton
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Jackson
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Reno
country: United States
state: Nevada
city: Lebanon
country: United States
state: New Hampshire
city: New Brunswick
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Northport
country: United States
state: New York
city: Lawton
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Pittsburgh
country: United States
state: Pennsylvania
city: Johnson City
country: United States
state: Tennessee
city: Tacoma
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: