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Burbank, California 91595

  • Cell

Purpose:

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.


Study summary:

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc. Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.


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)


Study is Available At:


Original ID:

13603


NCT ID:

NCT00206726


Secondary ID:


Study Acronym:

ECO-1


Brief Title:

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)


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bayer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Actual


Overall Contact Information

Official Name:Bayer Study Director
Study Director
Bayer

Study Dates

Start Date:May 2005
Completion Date:April 2008
Completion Type:Actual
Primary Completion Date:April 2008
Primary Completion Type:Actual
Verification Date:December 2010
Last Changed Date:December 8, 2010
First Received Date:September 19, 2005
First Results Date:November 19, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:Complete Response (CR)
Time Frame:28 days after last cycle with confirmation 2 months later
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Overall Response (OR)
Time Frame:28 days after last cycle with confirmation 2 months later
Safety Issues:False
Description:Participant had either complete response (CR) or partial response (PR) at 28 days after last treatment cycle (date of OR) and at Months 2 follow-up. PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphadenop
Outcome Type:Secondary Outcome
Measure:Overall Survival (OS)
Time Frame:1 year after start of treatment
Safety Issues:False
Description:Percentage of participants alive 1 year after the first dose date, described as Kaplan-Meier estimate at 1 year
Outcome Type:Secondary Outcome
Measure:Progression-free Survival (PFS)
Time Frame:1 year after start of treatment
Safety Issues:False
Description:Percentage of participants who survived progression-free at 1 year, described as Kaplan-Meier estimate at 1 year
Outcome Type:Secondary Outcome
Measure:Percentage of Participants With Overall Response at Different Observation Times
Time Frame:from first date of confirmed response until relapse, or death, or study data cutoff date, whichever
Safety Issues:False
Description:Participant had either complete response (CR) or partial response (PR) at different observation times (after 90 days; after 180 days; after 270 days). PR requires for at least 2 months: 50% decrease from Baseline in peripheral blood lymphocytes, lymphaden
Outcome Type:Secondary Outcome
Measure:Number of Participants With Minimal Residual Disease (MRD)
Time Frame:When CR is confirmed
Safety Issues:False
Description:Presence of MRD was assessed by laboratory testing of molecular responses in blood and bone marrow samples.

Study Interventions

Intervention Type:Drug
Name:Alemtuzumab plus Fludarabine
Description:Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
Arm Name:Alemtuzumab plus Fludarabine

Study Arms

Study Arm Type:Experimental
Arm Name:Alemtuzumab plus Fludarabine
Description:Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Bayer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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