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

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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00302861

Enrollment

Registered

2006-03-15

Start date

2006-03-31

Completion date

Unknown

Last updated

2008-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-Cell Chronic Lymphocytic Leukemia

Keywords

B-Cll

Brief 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.

Interventions

BIOLOGICALMyVax

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The proportion of patients with positive humoral immune responses	—
Safety and toxicity	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026