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CD19-specific T-cell for Chronic Lymphocytic Leukemia (CLL)

NCT01653717 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-08-17

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerable dose of T cells that can be given in combination with standard chemotherapy to patients with CLL. The safety of this combination will also be studied.

The T cells being used in this study are a type of white blood cell that will be taken from your blood and then genetically changed in a laboratory. The process of changing the DNA (the genetic material of cells) of the T cells is called a gene transfer. After the gene transfer is complete, the genetically changed T-cells will be put back into your body. These T cells may help prevent cancer cells from coming back.

Conditions

Interventions

PROCEDURE

Leukapheresis

Blood drawn through a needle in a vein in one arm, then passed though a machine to collect white blood cells, and then remaining blood returned back to patient through a needle in a vein in other arm. Procedure will take about 3 hours to complete.

DRUG

Fludarabine

25 mg/m2 by vein on Days -5 to Day -3.

DRUG

Cyclophosphamide

250 mg/kg by vein on Days -5 to -3.

PROCEDURE

T-cell Infusion

Beginning dose of genetically modified cells is \> 5x10\^7/m2 but less than or equal to 5 x10\^8/m2 infused on Day 0.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Chitra M. Hosing, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-11
Primary Completion
2017-08-07
Completion
2017-08-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01653717 on ClinicalTrials.gov