Phase 1/2 Study to Evaluate the Feasibility and Tolerability of Treatment of Previously Untreated B-CLL Chronic Lymphocytic Leukemia (B-CLL) Patients With Recombinant Idiotype Conjugated to KLH (Id-KLH) Administered With GM-CSF
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
B-Cell Chronic Lymphocytic Leukemia
Both
B-Cell Chronic Lymphocytic Leukemia
Trial Information
Phase 1/2 Study to Evaluate the Feasibility and Tolerability of Treatment of Previously Untreated B-CLL Chronic Lymphocytic Leukemia (B-CLL) Patients With Recombinant Idiotype Conjugated to KLH (Id-KLH) Administered With GM-CSF
Inclusion Criteria:
- Have signed a written informed consent
- B-CLL diagnosis
- Rai Stage 0, I, or II
- Previously untreated
- Be able to watch and wait for approximately 8 months following submission of blood
(or tissue) while Id-KLH is being manufactured
Exclusion Criteria:
- Anti-leukemia treatment prior to beginning immunization
- Anti-leukemia treatment other than Id-KLH during immunizations
- Prior malignancy (excluding basal cell carcinoma and cervical carcinoma in situ)
- Pregnant or lactating
- Patients with known autoimmune disease (including previously treated autoimmune
hemolytic anemia or immune thrombocytopenia)
- Participation in any other clinical trial in which an investigational agent is
administered
Type of Study:
Interventional
Study Design:
N/A
Outcome Measure:
The proportion of patients with positive humoral immune responses
Principal Investigator
Thomas Kipps, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, San Diego
Authority:
United States: Food and Drug Administration
Study ID:
2005-11
NCT ID:
NCT00302861
Start Date:
March 2006
Completion Date:
Related Keywords:
- B-cell Chronic Lymphocytic Leukemia
- B-Cll
- B-CLL
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
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