NCT01013441

Brief Summary

The purpose of this research study is to test whether giving T-cells (type of white blood cell that are also known as immune cells) that have been specially processed in the laboratory will help chronic lymphocytic leukemia (CLL) patients' immune system return to normal faster after chemotherapy. This research study will also look into the ability of the lab to process the T-cells for infusion and the side effects of giving T-cells to patients with chronic lymphocytic leukemia (CLL).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

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

March 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

9.8 years

First QC Date

November 5, 2009

Last Update Submit

October 21, 2019

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (3)

  • The occurrence of treatment-related adverse events or treatment related trial discontinuations, defined as NCI CTC ≥ grade 3 and clinical events that are possible, likely, or definitely related to study treatment at any time

    Two years

  • The ability to complete the outlined course of therapy

    Two years

  • The ability to harvest, expand, and reinfuse autologous T cells in this target population of patients

    Two years

Study Arms (1)

Treatment Arm

EXPERIMENTAL
Biological: Infusion of CD3/CD28 stimulated T cells

Interventions

Infusion of CD3/CD28 stimulated T cellsBIOLOGICAL

Receive CD3/CD28 stimulated T cells after fludarabine or alemtuzumab based chemotherapy

Also known as: Activated T cells, CD3/CD28 stimulated T cells, T cells
Treatment Arm

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of CLL by immunophenotyping and flow cytometry analysis of blood or bone marrow.
  • Patients with Rai stage III-IV - OR - Patients with Rai stage 0-II
  • Zubrod performance status of 0-3
  • Prior treatment with fludarabine or alemtuzumab based regimens.
  • No untreated or uncontrolled life-threatening infection
  • Women of childbearing potential must have a negative serum pregnancy test and agree to use a medically accepted form of contraception from the time of initial screening through completion of the study
  • No active CNS disease
  • Negative tests for HIV antibodies, Hepatitis B surface antigen, and hepatitis C antibodies.

You may not qualify if:

  • Receipt of glucocorticoids (with the exception of inhaled glucocorticoid steroids for the use of allergic rhinitis or pulmonary disease) within 2 months prior to registration
  • History of autoimmune disease unrelated to CLL (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis). Autoimmune disease related to CLL, e.g.
  • idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is permitted if not requiring active treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Abramson Cancer Center, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MD Anderson Cancer Center, University of Texas

Houston, Texas, 77030, United States

Location

Related Links

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

  • Stephen J Schuster, MD

    Abramson Cancer Center, University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Chitra Hosing, MD

    M.D. Anderson Cancer Center

    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
SPONSOR

Study Record Dates

First Submitted

November 5, 2009

First Posted

November 13, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 23, 2019

Record last verified: 2019-10

Locations

US(2)