Posted by on Sep 3, 2017 in Leukemia | 0 comments

In a nutshell

This phase 1/2 clinical trial will test the effectiveness of chimeric antigen receptor (CAR) T-cells in treating chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL), and non-Hodgkin’s lymphoma (NHL). The primary outcome will be measured by the response to treatment, overall survival, and the maximum tolerated dose. The trial is being conducted at Fred Hutch/University of Washington Cancer Consortium in Seattle, Washington.

 

The details

CAR T-cell therapy uses the patient’s own T-cells to fight B-cell blood cancers. The patient’s T-cells are collected and genetically engineered to express a receptor for the CD19 marker, a specific protein found on many cancerous B-cells. After the T-cells are injected back into the body, they are able to identify which cells are cancerous and initiate an attack against them.

The study will examine the highest dose of T-cells tolerated for 30 days, the movement of CAR-T cells throughout the body for 1 year, response rate for 1 year, overall survival and time until the disease progresses for up to 15 years.

 

Who are they looking for?

This trial is recruiting 189 patients with CD19 positive ALL, CLL, or NHL. Patients with CLL should be beyond first remission and have failed a purine analog and anti CD20 immunochemotherapy or not be eligible for the therapy. Patients with indolent or mantle cell NHL should be beyond first remission and have previously received chemoimmunotherapy (or be ineligible). Aggressive NHL patients should have relapsed or have residual disease after treatment. Those with ALL must have relapsed or refractory disease.

Ideal candidates will not require over 15 mg of corticosteroids a day or have an autoimmune disease requiring immunosuppressive therapy.

 

How will it work

Patients will undergo a laboratory procedure to collect T-cells that will be genetically engineered. On day 0 the CAR T-cells will be delivered back to the patients through an IV. Some patients may receive an additional infusion of the CAR-T cells 10-21 days after the first infusion.

Patients will be followed for at least 15 years. 

Clinical trial locations

Locations near 43201, United States (Change):
Please enter zip/postal code and country to help us offer locations near you
Show only recruiting locations
Type:Interventional
Participants:204
Study ID:NCT01865617
Want personalized notifications? Get notified only when trials are matching for you.
(it's free)