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Maintenance Alemtuzumab in Refractory Chronic Lymphocytic Leukemia


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

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Trial Information

Maintenance Alemtuzumab in Refractory Chronic Lymphocytic Leukemia


This is an open-label, single arm, proof-of-principle study of alemtuzumab maintenance
therapy administered subcutaneously at varying intervals for up to 1 year. Ongoing
prophylactic anti-infectives will be provided. Patients will be assessed for response every
2 months and for quality of life every 3 months while on treatment. Patients achieving a
presumptive complete response will receive no further treatment but will be followed for
response. Non-responding patients, with confirmed progressing disease following a minimum
of 8 doses will be discontinued from treatment and followed for survival. Responding
patients or patients with stable disease will undergo confirmatory assessment 2 months
following their end-of-treatment assessment. If remission has occurred, patients will be
followed off treatment until documented disease progression.


Inclusion Criteria:



- Enrollment in this study is open to patients 18 years of age with confirmed CLL, a
clinical response of stable disease or better to previous treatment, and an Eastern
Cooperative Oncology Group performance status of 0-2

Exclusion Criteria:

- Treatment failure in more than 3 prior regimens

- Active secondary malignancy

- Central nervous system involvement with CLL

- History of significant allergic reaction to antibody therapies that required
discontinuation of the antibody therapy

- History of HIV positivity

- Hepatitis C virus (HCV) positivity based upon core antigen testing

- Active infection, requiring treatment with antibiotic, antiviral, or antifungal
agents

- Pregnancy or lactation

- Other severe, concurrent diseases or mental disorders

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to progression

Outcome Time Frame:

Every 8 weeks

Safety Issue:

No

Principal Investigator

Kanti R. Rai, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Long Island Jewish Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

05.10.030

NCT ID:

NCT00587847

Start Date:

May 2005

Completion Date:

November 2009

Related Keywords:

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

Name

Location

Long Island Jewish Medical CenterNew Hyde Park, New York  11040