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Fludarabine (Fludara®) Plus Alemtuzumab (CAMPATH®, MabCampath®) vs Fludarabine Alone in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Fludarabine (Fludara®) Plus Alemtuzumab (CAMPATH®, MabCampath®) vs Fludarabine Alone in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients

A Phase III Randomized Trial to Evaluate the Efficacy and Safety of Second-Line Therapy With Fludarabine Plus Alemtuzumab vs. Fludarabine Alone in Patients With B-Cell Chronic Lymphocytic Leukemia

NCT00086580•Genzyme, a Sanofi Company

View on ClinicalTrials.gov

Summary

This is a Phase 3, prospective, multicenter, open-label, randomized, controlled study to evaluate and compare the efficacy and safety of fludarabine plus alemtuzumab versus fludarabine alone as second-line therapy for patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL). Patients who meet all eligibility criteria and sign the informed consent document may be entered on the study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A diagnosis of B-cell chronic lymphocytic leukemia (B-CLL); according to the National Cancer Institute Working Group (NCI WG) criteria.
•Relapsed or refractory disease after 1 prior regimen except patients who were refractory to (i.e., progressed on) fludarabine or alemtuzumab therapy. Patients who previously responded (complete response or partial response) to fludarabine or alemtuzumab therapy, but who have relapsed at the time of study entry, may be eligible but response to fludarabine or alemtuzumab therapy must have lasted \>12 months (i.e., \>12 months from a documented response to a documented relapse).
•Binet stage A, stage B, or stage C or Rai Stage I through IV disease with evidence of progression as evidenced by the presence of one or more of the following:
•I. Evidence of progressive marrow failure as manifested by: 1) a decrease in hemoglobin to \<11g/dL, or 2) a decrease in platelet count to \<100 x 10\^9/L within the previous 6 months, or 3) a decrease in absolute neutrophil count (ANC) to \<1.0 X 10\^9/L.
•II. Progressive splenomegaly to \>2 cm below the left costal margin or other organomegaly.
•III. Progressive lymphadenopathy.
•IV. Progressive lymphocytosis with an increase of 50% over a 2-month period, or an anticipated doubling time of less than 6 months.
•World Health Organization (WHO) performance status (PS) of 0 or 1.
•Life expectancy \>12 weeks.
•Anti-cancer therapy, major surgery, or irradiation was completed \>3 weeks before randomization in this study. Patient must have recovered from the acute side effects incurred as a result of previous therapy.
+4 more criteria

Exclusion Criteria

•Previously treated with \>1 prior regimen for B-CLL.
•Previously treated with a fludarabine plus alemtuzumab (FluCAM) regimen for B-CLL.
•Positive Coombs test and actively hemolyzing.
•Absolute neutrophil count (ANC) \<1.5 x 10\^9/L or platelet count \<75 x 10\^9/L, unless due to bone marrow involvement.
•Medical condition requiring chronic use of pharmacologic doses of oral corticosteroids, i.e. anything other than replacement dose levels.
•History of anaphylaxis following exposure to monoclonal antibodies.
•Use of investigational agents within 6 weeks prior to study randomization.
•Active infection or history of severe infection (grade 4) within 3 months prior to study randomization.
•Known to be human immunodeficiency virus (HIV) positive.
•Autoimmune thrombocytopenia.
+6 more criteria

Locations (48)

Florida Cancer Specialists

Fort Myers, Florida, United States

Medizinische Universitatsklinik Graz

Graz, Austria

Universitat Wien AKH, Innere Medizin I

Vienna, Austria

University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski

Pleven, Bulgaria

UMHAT St. Georgi, Hematology Clinic

Plovdiv, Bulgaria

Multiprofile Hospital for Active Treatment "Alexandrovska"

Sofia, Bulgaria

National Center for Heamtology and Transfusiology

Sofia, Bulgaria

Multiprofile Hospital for Active Treatment, St. Marina

Varna, Bulgaria

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

Hopital Notre-Dame du CHUM

Montreal, Quebec, Canada

Key Dates

Start Date

July 1, 2004

Primary Completion Date

June 1, 2010

Completion Date

June 1, 2010

Last Updated

March 13, 2014

Enrollment

335

ACTUAL participants

Conditions

B-Cell Chronic Lymphocytic Leukemia

Interventions

FluCAM [Fludara + Campath]

BIOLOGICAL

fludarabine phosphate

BIOLOGICAL

Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma

NCT03110640

B-cell Adult Acute Lymphoblastic LeukemiaB-cell Chronic Lymphocytic Leukemia+3 more

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TERMINATEDPHASE1/PHASE2

Safety and Dose Ranging Study of Samalizumab to Treat Relapsing or Refractory CLL or MM

NCT00648739

B-cell Chronic Lymphocytic LeukemiaMultiple Myeloma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Fludarabine (Fludara®) Plus Alemtuzumab (CAMPATH®, MabCampath®) vs Fludarabine Alone in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients

Inclusion Criteria

Exclusion Criteria

Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma

Safety and Dose Ranging Study of Samalizumab to Treat Relapsing or Refractory CLL or MM

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