A Study to Evaluate the Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL)

B-Cell Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00302861
• Other study ID #: 2005-11
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: March 13, 2006
• Last updated: March 14, 2008
• Start date: March 2006

Study information

• Verified date: March 2008
• Source: Genitope Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, open-label, single arm Phase 1/2 study evaluating the feasibility, safety, and tolerability of a series of 16 immunizations of Id-KLH with GM-CSF in patients with previously untreated B-CLL. The length of the controlled portion of the study is two years. The study will be conducted at investigative sites in the United States.

Other known NCT identifiers

• NCT00313651

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 86
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

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

Intervention

Biological:
• MyVax

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genitope Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with positive humoral immune responses
Primary	Safety and toxicity