Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
ECO-1
Phase II Study Using Alemtuzumab Combined With Fludarabine for the Treatment of Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
2 other identifiers
interventional
60
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2005
Typical duration for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 19, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
January 13, 2011
CompletedAugust 29, 2016
July 1, 2016
2.9 years
September 19, 2005
November 19, 2009
July 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Complete Response (CR)
Participants evaluated for therapeutic clinical response according to National Cancer Institute (NCI) response criteria, 28 days after 4 or 6 treatment cycles. Response confirmation involved bone marrow biopsy and aspirate performed 2 months after final treatment. CR requires for at least 2 months: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count (CBC); confirmed by bone marrow aspirate and biopsy 2 months later with lymphocytes \<30% of nucleated cells and procedure repeated in 4 weeks if hypocellular.
28 days after last cycle with confirmation 2 months later
Secondary Outcomes (5)
Overall Response (OR)
28 days after last cycle with confirmation 2 months later
Overall Survival (OS)
1 year after start of treatment
Progression-free Survival (PFS)
1 year after start of treatment
Percentage of Participants With Overall Response at Different Observation Times
from first date of confirmed response until relapse, or death, or study data cutoff date, whichever is earlier
Number of Participants With Minimal Residual Disease (MRD)
When CR is confirmed
Study Arms (1)
Alemtuzumab plus Fludarabine
EXPERIMENTALAlemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days.
Interventions
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
Eligibility Criteria
You may qualify if:
- Patient must have confirmed B-CLL.
- Patients must have received at least one prior therapy and must require treatment for active disease
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Unknown Facility
Birmingham, Alabama, 35223, United States
Unknown Facility
Berkeley, California, 94704, United States
Unknown Facility
Burbank, California, 91595, United States
Unknown Facility
Concord, California, 94520, United States
Unknown Facility
Stanford, California, 94305-5118, United States
Unknown Facility
Washington D.C., District of Columbia, 20422, United States
Unknown Facility
Lakeland, Florida, 33805, United States
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Aurora, Illinois, 60504, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Springfield, Illinois, 62703, United States
Unknown Facility
Metairie, Louisiana, 70006, United States
Unknown Facility
Clinton, Maryland, 20735, United States
Unknown Facility
Boston, Massachusetts, 02115, United States
Unknown Facility
Jackson, Michigan, 39202, United States
Unknown Facility
Minneapolis, Minnesota, 55417, United States
Unknown Facility
Reno, Nevada, 89520, United States
Unknown Facility
Lebanon, New Hampshire, 03756-0001, United States
Unknown Facility
New Brunswick, New Jersey, 08903-2681, United States
Unknown Facility
Albany, New York, 12208-3473, United States
Unknown Facility
Northport, New York, 11768, United States
Unknown Facility
Lawton, Oklahoma, 73505, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15224, United States
Unknown Facility
Johnson City, Tennessee, 37604, United States
Unknown Facility
Tacoma, Washington, 98431-5000, United States
Unknown Facility
Milwaukee, Wisconsin, 53226-3596, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2005
First Posted
September 21, 2005
Study Start
May 1, 2005
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
August 29, 2016
Results First Posted
January 13, 2011
Record last verified: 2016-07