Continuous Infusion of Campath-1H Followed by Subcutaneous Injections in Previously Treated Patients With Chronic Lymphocytic Leukemia


Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia

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Trial Information

Continuous Infusion of Campath-1H Followed by Subcutaneous Injections in Previously Treated Patients With Chronic Lymphocytic Leukemia


The purposes of this trial are:

1. To evaluate the response rate (CR+PR) to CAMPATH-1H given as continuous infusion
followed by subcutaneous injection in patients with previously treated CLL who have
failed fludarabine therapy.

2. To evaluate whether CAMPATH-1H, given as a continuous infusion followed by subcutaneous
injections to patients with previously treated CLL will improve tolerability of the
agent and permit higher doses to be delivered through that route.

3. To evaluate the pharmacokinetics of CAMPATH-1H when given as a 24 hour continuous
infusion followed by a subcutaneous injection.


Inclusion Criteria:



- Age >= 18 years (CLL does not occur in the pediatric population).

- Signed informed consent.

- World Health Organization (WHO) performance status of 0, 1, or 2.

- Patients with B-CLL who have received fludarabine and are either refractory to
frontline therapy or have relapsed within six months from receiving fludarabine-based
therapy. Patients previously treated with Campath-1H are eligible.

- Serum creatinine <= 2mg/dL, total bilirubin <= 2mg/dL, and SGPT <= 3x upper limit of
normal (ULN) unless due to direct infiltration of the liver or kidney with malignant
cells.

Exclusion Criteria:

- Past history of anaphylaxis, following exposure to rat or mouse derived CDR-grafted
humanized monoclonal antibodies.

- Prior chemotherapy, immunotherapy, or hormonal therapy within 2 weeks prior to study
start. Hormonal replacement therapy is permitted. Prior therapy with monoclonal
antibodies for at least 4 weeks prior to study start.

- Pregnant or nursing women or any patient of childbearing age unwilling to practice an
acceptable form of contraception.

- Patients with history of HIV positivity.

- Active secondary malignancy.

- Active uncontrolled infection or any major systemic or other illness 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:

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

Outcome Measure:

Response Rate (CR+PR) to CAMPATH-1H

Outcome Description:

Rate is number of patients with CR+PR response to CAMPATH-1H where CR is Complete Response and PR is Partial Response RECIST.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Alessandra Ferrajoli, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID02-424

NCT ID:

NCT00102661

Start Date:

October 2002

Completion Date:

September 2006

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030