NCT00428233

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

7.6 years

First QC Date

January 25, 2007

Last Update Submit

April 6, 2020

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLLvaccine

Outcome Measures

Primary Outcomes (1)

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

    2 years

Study Arms (1)

Leukemia Cell Harvest

NO INTERVENTION

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

Procedure: Leukemia cell harvest

Interventions

Leukemia cell harvestPROCEDURE

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

Leukemia Cell Harvest

Eligibility Criteria

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

You may qualify if:

  • 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
  • years of age or older

You may not qualify if:

  • Uncontrolled infection
  • Leukemia with active CNS involvement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

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

  • Catherine J. Wu, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

November 1, 2006

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 8, 2020

Record last verified: 2020-04

Locations

US(1)