A Study to Evaluate the Treatment of Previously Untreated... | NCT00302861

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

NCT00302861

Sponsor

Genitope Corporation

Status

Terminated

Last Update Posted

Mar 18, 2008Estimated

Enrollment

Phase

Phase 1Phase 2

Conditions

B-Cell Chronic Lymphocytic Leukemia

Interventions

MyVax

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Mar 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 13, 2006

First Submission Date that Met QC Criteria

Mar 13, 2006

First Posted Date

Mar 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2008

Last Update Posted Date

Mar 18, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
MyVax	Biological

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Thomas Kipps, M.D.	University of California, San Diego	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D015451	Leukemia, Lymphocytic, Chronic, B-Cell

Ancestor Terms

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
The proportion of patients with positive humoral immune responses
Safety and toxicity