NCT00302861

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P75+ for phase_1

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2006

Completed
Last Updated

March 18, 2008

Status Verified

March 1, 2008

First QC Date

March 13, 2006

Last Update Submit

March 14, 2008

Conditions

B-Cell Chronic Lymphocytic Leukemia

Keywords

B-Cll

Outcome Measures

Primary Outcomes (2)

  • The proportion of patients with positive humoral immune responses

  • Safety and toxicity

Interventions

MyVaxBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Kipps, M.D.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 13, 2006

First Posted

March 15, 2006

Study Start

March 1, 2006

Last Updated

March 18, 2008

Record last verified: 2008-03