Maintenance Alemtuzumab in Refractory Chronic Lymphocytic Leukemia
18 Years
N/A
Both
Chronic Lymphocytic Leukemia
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 Center | New Hyde Park, New York 11040 |
