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A Multi-Center Phase II Efficacy and Pharmacokinetic Study Evaluating Fludarabine, Cyclophosphamide, and Subcutaneous Campath (FCCam) for Previously Untreated B-Cell Chronic Lymphocytic Leukemia


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, B-Cell, Chronic, Leukemia, Chronic Lymphocytic Leukemia (CLL)

Thank you

Trial Information

A Multi-Center Phase II Efficacy and Pharmacokinetic Study Evaluating Fludarabine, Cyclophosphamide, and Subcutaneous Campath (FCCam) for Previously Untreated B-Cell Chronic Lymphocytic Leukemia


Inclusion Criteria:



- Male or female, age 18 or older, with a confirmed immunohistological diagnosis of CLL

- Signed written informed consent

- Karnofsky performance status 60% or above (Appendix E)

- Advanced stage disease (Rai Stage III or IV, or modified Rai High Risk).

- Patients with Rai Stage I - II or (Modified Rai Intermediate-Risk) disease must have
an indication for therapy based on 1996 NCI revised criteria for active disease as
follows:

- Any one of the following disease-related symptoms:

1. Weight loss >= 10% within the previous 6 months

2. Extreme fatigue

3. Fever greater than 100.5┬░ F for >= 2 weeks without evidence of infection

4. Night sweats without evidence of infection

- Evidence of progressive marrow failure based on the development of worsening of
anemia or thrombocytopenia

- Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid
therapy

- Massive (> 6 cm below the left costal margin) or progressive splenomegaly

- Bulky (>10 cm in cluster) or progressive lymphadenopathy

- Progressive lymphocytosis > 50% increase over 2 months, or anticipated doubling
time < 6 months

- Patients with immunoglobulin VH gene in unmutated nucleotide sequence configuration,
as defined by >= 98% homology with the nearest germline counterpart, regardless of
Rai Stage.

- Serum creatinine <= 2x the upper limit of normal. Total serum bilirubin, AST, and
ALT: <= 2x the upper limit of normal.

Exclusion Criteria:

- Prior pharmacological treatment for CLL.

- Any medical condition requiring systemic corticosteroids.

- Active systemic infection.

- HIV positive by serologic testing.

- Past history of anaphylaxis following exposure to monoclonal antibodies.

- Active secondary malignancy or a history of malignant disease (other than CLL or
non-melanoma skin cancer) within the preceding 5 years.

- Pregnant or nursing women, or unwilling/unable to practice an acceptable form of
contraception. Treatment with the study agents would expose an unborn child to
significant risks.

- Major systemic or other illness (including Coombs positivity and active hemolysis)
that would, in the opinion of the investigator, interfere with the patient's ability
to comply with the protocol, compromise patient safety, or interfere with the
interpretation of study results.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the efficacy of FCCam in patients with previously untreated B-cell Chronic Lymphocytic Leukemia(CLL), as measured by rates and duration of clinical and laboratory responses, and the incremental effect of Campath® on the response rate

Outcome Time Frame:

unknown

Safety Issue:

No

Principal Investigator

Steven Edward Coutre

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Food and Drug Administration

Study ID:

HEMCLL0001

NCT ID:

NCT00230282

Start Date:

July 2004

Completion Date:

October 2011

Related Keywords:

  • Leukemia, B-Cell, Chronic
  • Leukemia
  • Chronic Lymphocytic Leukemia (CLL)
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, B-Cell

Name

Location

Stanford University School of Medicine Stanford, California  94305-5317