Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL) (ECO-1)
This study has been completed.
Sponsor:
Genzyme
Information provided by (Responsible Party):
Genzyme
ClinicalTrials.gov Identifier:
NCT00206726
First received: September 19, 2005
Last updated: November 23, 2011
Last verified: November 2011
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia, Lymphocytic, Chronic, B-Cell |
Drug: Alemtuzumab plus Fludarabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study Using Alemtuzumab Combined With Fludarabine for the Treatment of Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL) |
Resource links provided by NLM:
Further study details as provided by Genzyme:
Primary Outcome Measures:
- Complete Response (CR) [ Time Frame: 28 days after last cycle with confirmation 2 months later ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Overall Response (OR) [ Time Frame: 28 days after last cycle with confirmation 2 months later ] [ Designated as safety issue: No ]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, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease.
- Overall Survival (OS) [ Time Frame: 1 year after start of treatment ] [ Designated as safety issue: No ]Percentage of participants alive 1 year after the first dose date, described as Kaplan-Meier estimate at 1 year
- Progression-free Survival (PFS) [ Time Frame: 1 year after start of treatment ] [ Designated as safety issue: No ]Percentage of participants who survived progression-free at 1 year, described as Kaplan-Meier estimate at 1 year
- 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 is earlier ] [ Designated as safety issue: No ]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, lymphadenopathy, liver/spleen size, presence or absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100000/μL platelets, >11.0 g/dL hemoglobin, or 50% improvement from Baseline for these parameters without transfusions, nodular CR or persistent anemia/thrombocytopenia unrelated to disease.
- Number of Participants With Minimal Residual Disease (MRD) [ Time Frame: When CR is confirmed ] [ Designated as safety issue: No ]Presence of MRD was assessed by laboratory testing of molecular responses in blood and bone marrow samples.
| Enrollment: | 60 |
| Study Start Date: | May 2005 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Alemtuzumab plus Fludarabine
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days.
|
Drug: Alemtuzumab plus Fludarabine
Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206726
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Hide Study LocationsLocations
| United States, Alabama | |
| Birmingham, Alabama, United States, 35223 | |
| United States, California | |
| Berkeley, California, United States, 94704 | |
| Burbank, California, United States, 91595 | |
| Concord, California, United States, 94520 | |
| Stanford, California, United States, 94305-5118 | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20422 | |
| United States, Florida | |
| Lakeland, Florida, United States, 33805 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Aurora, Illinois, United States, 60504 | |
| Chicago, Illinois, United States, 60637 | |
| Springfield, Illinois, United States, 62703 | |
| United States, Louisiana | |
| Metairie, Louisiana, United States, 70006 | |
| United States, Maryland | |
| Clinton, Maryland, United States, 20735 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Jackson, Michigan, United States, 39202 | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States, 55417 | |
| United States, Nevada | |
| Reno, Nevada, United States, 89520 | |
| United States, New Hampshire | |
| Lebanon, New Hampshire, United States, 03756-0001 | |
| United States, New Jersey | |
| New Brunswick, New Jersey, United States, 08903-2681 | |
| United States, New York | |
| Albany, New York, United States, 12208-3473 | |
| Northport, New York, United States, 11768 | |
| United States, Oklahoma | |
| Lawton, Oklahoma, United States, 73505 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, Tennessee | |
| Johnson City, Tennessee, United States, 37604 | |
| United States, Washington | |
| Tacoma, Washington, United States, 98431-5000 | |
| United States, Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226-3596 | |
Sponsors and Collaborators
Genzyme
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Genzyme |
| ClinicalTrials.gov Identifier: | NCT00206726 History of Changes |
| Other Study ID Numbers: | 13603 |
| Study First Received: | September 19, 2005 |
| Results First Received: | November 19, 2009 |
| Last Updated: | November 23, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Fludarabine Fludarabine monophosphate Alemtuzumab Campath 1G |
Vidarabine Antibodies, Neoplasm Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on June 17, 2013