Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients With Progressive B-Cell Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00046683
First received: October 1, 2002
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

This is a Phase III, open-label, multicenter, randomized, comparative study of Campath versus chlorambucil as front line therapy in patients with progressive B-Cell Lymphocytic Leukemia (B-CLL). Eligible patients must have previously untreated, Rai stage I-IV disease, and be experiencing progression of their B-CLL requiring treatment. Patients who meet all eligibility criteria may be randomized on a 1:1 basis to receive either Campath or chlorambucil. An estimated 284 patients (142 per treatment arm) from approximately 40 or more investigational sites will be randomized to one of the two treatment arms.


Condition Intervention Phase
B Cell Chronic Lymphocytic Leukemia
Drug: alemtuzumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Study to Evaluate the Efficacy and Safety of Front-Line Therapy With Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients With Progressive B-Cell Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Campath vs. chlorambucil

Secondary Outcome Measures:
  • survival comparison

Estimated Enrollment: 284
Study Start Date: July 2001
Estimated Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histopathologically confirmed diagnosis of B-CLL with CD5, CD19, or CD23 positive clone.
  • Rai Stage I through IV disease with evidence of progression as evidenced by the presence of one or more of the following:1. Disease-related B symptoms (fever of greater than 38 celsius (100.5 F) for greater than or equal to 2 weeks without evidence of infection, night sweats without evidence of infection, weight loss >10% within previous 6 months. 2. Evidence of progression marrow failure as manifested by: a. decrease in hemoglobin to <11g/dL or b. decrease in platelet count to <100x10 to the ninth/L within the previous 6 months or c. decrease in absolute neutrophil count (ANC) to <1.0x10 to the ninth/L within the previous 6 months. 3. Progressive splenomegaly to >2 cm below the left costal margin or other organomegaly with progressive increase over 2 consecutive clinic visits greater than or equal to 2 weeks apart. 4. Progressive lymphadenopathy with at least 5 sites of involvement with either two nodes at least 2cm in longest diameter or one node greater than or equal to 5cm in longest diameter with progressive increase over 2 consecutive visits greater than or equal to weeks apart. 5. Progressive lymphocytes with an increase of >50% over a 2-month period, or an anticipated doubling time of less than 6 months.
  • Received no previous chemotherapy for B-CLL.
  • Life expectancy of at least 12 weeks.
  • WHO performance status of 0, 1, or 2.
  • Serum creatinine less or equal to 2.0 times the institutional upper limit of normal (ULN) value.
  • Adequate liver function as indicated by a total bilirubin, AST, and ALT less or equal to 2 times the institutional ULN value, unless directly attributable to the disease.
  • Female patients with childbearing potential must have a negative serum pregnancy test within 2 weeks prior to randomization. Male and female patients must agree to use an effective contraceptive method while on study treatment, if appropriate, and for a minimum of 6 months after study therapy.
  • Signed, written informed consent.
  • 18 years of age or older.

Exclusion Criteria:

  • ANC less than 500 million per liter or platelet count less than 10 billion per liter.
  • Medical condition requiring chronic use of oral corticosteroids.
  • Autoimmune thrombocytopenia.
  • Previous bone marrow transplant.
  • Use of investigational agents within previous 30 days.
  • Positive for HIV.
  • Past history of anaphylaxis following exposure to rat or mouse-derived complementary determining region (CDR) grafted humanized monoclonal antibodies.
  • Active infection.
  • Serious cardiac or pulmonary disease that could interfere with their ability to participate in the study.
  • Recent documented (with in 2 years) of active tuberculosis (TB), current active TB, or currently receiving anti-tuberculosis medication.
  • Active secondary malignancy.
  • Central nervous system involvement with CLL.
  • Positive quantitative CMV by PCR assay (using the laboratory normal ranges).
  • A diagnosis of mantle cell lymphoma.
  • Other severe, concurrent diseases or mental disorders.
  • Pregnant or lactating women.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046683

Locations
United States, Arizona
Tucson, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, Florida
Ft. Myers, Florida, United States
Tampa, Florida, United States
United States, Illinois
Hines, Illinois, United States
United States, Kentucky
Louisville, Kentucky, United States
Paducah, Kentucky, United States
United States, Louisiana
Lafayette, Louisiana, United States
United States, Mississippi
Jackson, Mississippi, United States
Tupelo, Mississippi, United States
United States, Missouri
Jefferson City, Missouri, United States
Kansas City, Missouri, United States
United States, Montana
Billings, Montana, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New York
New Hyde Park, New York, United States
Rochester, New York, United States
United States, North Carolina
Durham, North Carolina, United States
United States, South Dakota
Sioux Falls, South Dakota, United States
United States, Texas
San Antonio, Texas, United States
United States, Virginia
Norfolk, Virginia, United States
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00046683     History of Changes
Other Study ID Numbers: CAM307
Study First Received: October 1, 2002
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Adult acute leukemia
Adult chronic leukemia
Childhood leukemia
Campath
Alemtuzumab

Additional relevant MeSH terms:
Leukemia
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Alemtuzumab
Chlorambucil
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014