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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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B-Cell Chronic Lymphocytic Leukemia

Keywords

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B-Cll

Interventions

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MyVax

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Thomas Kipps, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Countries

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United States

Other Identifiers

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2005-11

Identifier Type: -

Identifier Source: org_study_id

NCT00313651