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B Cell Chronic Lymphocytic LeukemiaPhase 3NCT00046683

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

A Phase 3 study testing alemtuzumab in people with B Cell Chronic Lymphocytic Leukemia, run by Genzyme, a Sanofi Company at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B Cell Chronic Lymphocytic Leukemia
What is being tested?
alemtuzumab
How many people
284 participants
Where
20 sitesUnited States
Study dates
Jul 2001to Jun 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Study site

    Billings, Montana

  • Study site

    Durham, North Carolina

  • Study site

    Fort Myers, Florida

  • Study site

    Hines, Illinois

  • Study site

    Jackson, Mississippi

  • Study site

    Jefferson City, Missouri

  • Study site

    Kansas City, Missouri

  • Study site

    Lafayette, Louisiana

  • Study site

    Little Rock, Arkansas

  • Study site

    Louisville, Kentucky

  • Study site

    New Hyde Park, New York

  • Study site

    Norfolk, Virginia

  • Study site

    Omaha, Nebraska

  • Study site

    Paducah, Kentucky

  • Study site

    Rochester, New York

  • Study site

    San Antonio, Texas

  • Study site

    Sioux Falls, South Dakota

  • Study site

    Tampa, Florida

  • Study site

    Tucson, Arizona

  • Study site

    Tupelo, Mississippi

Other trials in United States

About this study

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

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.

Being tested
alemtuzumab
Keywords
Adult acute leukemia, Adult chronic leukemia, Childhood leukemia, Campath, Alemtuzumab
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • alemtuzumabDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Campath vs. chlorambucil

Secondary outcomes (1)

  1. survival comparison

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2002 (estimated)
  2. Study startJul 2001
  3. Study completionJun 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
284 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00046683
Sponsor's protocol ID
CAM307
Status last verified
Jul 2016
First submitted
1 Oct 2002
Last updated
28 Jul 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing alemtuzumab in people with B Cell Chronic Lymphocytic Leukemia, run by Genzyme, a Sanofi Company at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Campath vs. chlorambucil. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00046683.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2016.

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