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Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation

Primary Purpose

Chronic Lymphocytic Leukemia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Leukemia cell harvest

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring CLL, vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ability to harvest CLL cells from peripheral blood, lymph nodes or bone marrow, defined as > 30% involvement of bone marrow intratrabecular space, or peripheral blood lymphocytosis > 5000/microliter, or surgically accessible lymph nodes of greater than or equal to 2cm.
ECOG performance status 0-2
18 years of age or older

Exclusion Criteria:

Uncontrolled infection
Leukemia with active CNS involvement

Sites / Locations

Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Leukemia Cell Harvest

Arm Description

Procedure/Surgery: Leukemia cell harvest Leukemia cells will be harvested either by: Blood draw, leukapheresis, bone marrow aspiration or surgery to remove the lymph node

Outcomes

Primary Outcome Measures

To collect up to 20 patient samples per year that could potentially be used to prepare autologous tumor cell vaccines.

Secondary Outcome Measures

Full Information

NCT ID

NCT00428233

First Posted

January 25, 2007

Last Updated

April 6, 2020

Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00428233

Brief Title

Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation

Official Title

Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

November 2006 (Actual)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this research study is to collect, freeze and store leukemia cells from the blood or bone marrow of patients that have advanced chronic lymphocytic leukemia (CLL) that is not in clinical remission. This study is a companion study to DF/HCC clinical trial 06-196 in which the participants' own CLL cells may form part of a vaccine treatment for their leukemia.

Detailed Description

It is important to understand that even if the participant consents to allow us to save their leukemia cells, we cannot guarantee that they will be able to receive a vaccine. First, we may not be able to make enough vaccine from the collected cells. Second, they may not be able to participate in a vaccine study in the future for reasons related to the status of your overall health. Third, an appropriate vaccine trial may not be available in the future. In order to make the vaccine, leukemia cells will be collected by one or more of the following methods: drawing blood during one of two visits to the clinic; leukapheresis; bone marrow aspiration; or, surgery to remove a lymph node. The physician will discuss with the participant which approach is best in their case to ensure the highest number of tumor cells collected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Lymphocytic Leukemia

Keywords

CLL, vaccine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Leukemia Cell Harvest

Arm Type

No Intervention

Arm Description

Procedure/Surgery: Leukemia cell harvest Leukemia cells will be harvested either by: Blood draw, leukapheresis, bone marrow aspiration or surgery to remove the lymph node

Intervention Type

Procedure

Intervention Name(s)

Leukemia cell harvest

Intervention Description

Leukemia cells will be harvested either by: Blood draw, leukapheresis, bone marrow aspiration or surgery to remove the lymph node

Primary Outcome Measure Information:

Title

To collect up to 20 patient samples per year that could potentially be used to prepare autologous tumor cell vaccines.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ability to harvest CLL cells from peripheral blood, lymph nodes or bone marrow, defined as > 30% involvement of bone marrow intratrabecular space, or peripheral blood lymphocytosis > 5000/microliter, or surgically accessible lymph nodes of greater than or equal to 2cm. ECOG performance status 0-2 18 years of age or older Exclusion Criteria: Uncontrolled infection Leukemia with active CNS involvement

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Catherine J. Wu, MD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation

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