Treatment of B-CLL With Autologous IL2 and CD40 Ligand-Expressing Tumor Cells + Lenalidomide (TAIL)
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|ClinicalTrials.gov Identifier: NCT01604031|
Recruitment Status : Terminated
First Posted : May 23, 2012
Last Update Posted : February 8, 2016
This is a research study to determine the safety and effectiveness of using special cells that may make the subject's immune system fight their chronic lymphocytic leukemia (CLL) in combination with a drug called Lenalidomide.
To do this, the investigators will put a special gene into cancer cells that have been taken from the subject. This will be done in the laboratory. This gene will make the cells produce interleukin 2 (IL-2), which is a natural substance that may help the subject's immune system kill cancer cells. Additionally, the investigators will stimulate the cancer cells with normal embryonic fibroblasts (cells that develop into normal connective tissues in the body) so that they will make another natural protein called CD40 ligand (CD40L). Some of these cells will then be put back into the subject's body with the goal that they will act like a vaccine and stimulate the immune system to attack the CLL cells.
The investigators have already conducted a study similar to this in other subjects with CLL. In those subjects the investigators saw some changes in the subject's immune system that might indicate that the modified cells were helping their immune system fight the cancer. However, in most of the subjects this change in the immune system went away after the injections were stopped. The investigators think that this may be due to a high level of cells called T regulatory cells. T regulatory cells are part of the immune system and prevent excessive reactions from other cells in the body. Studies have shown that reducing T regulatory cells allows the body to fight the cancer for a longer period of time.
Recent studies have shown that using Lenalidomide helps the body reduce T regulatory cells. Using Lenalidomide along with the injections (shots) might help the body fight the cancer for a longer period of time. Lenalidomide is also called Revlimid.
In this study the investigators want to see if they can make the change in the immune system last longer by giving Lenalidomide before and at the same time as the vaccine. The investigators hope that this might produce a better response directed at the CLL cells. Subjects will receive injections for about a year
|Condition or disease||Intervention/treatment||Phase|
|B-cell Chronic Lymphocytic Leukemia||Biological: B-CLL Vaccine Drug: Lenalidomide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of B-CLL With Autologous IL2 and CD40 Ligand-Expressing Tumor Cells + Lenalidomide|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Experimental: B-CLL vaccine
Patients will receive doses of vaccine at 2 week intervals for 5 doses and at 4 week intervals for doses 6-16. The injection will be performed subcutaneously in the deltoid region of the upper arm.
Biological: B-CLL Vaccine
Patients will receive a fixed dose (2X10^7) of IL-2 secreting B-cells together with (2X10^7) of hCD40L expressing B-cells. Patients will receive doses of vaccine at 2 week intervals for 5 doses. Barring adverse events, an additional 11 doses of vaccine will be given, at 4 weekly intervals beginning on week 12 for a total period of one year or 16 vaccinations in total.
Subjects will begin lenalidomide 5 mg orally daily on day zero and will continue daily dosing until week 60 (4 weeks after the final dose of vaccine).
Other Name: Revlimid
- Adverse Events after Lenalidomide with B-CLL cell vaccine [ Time Frame: week 60 ]To assess the safety of administration of lenalidomide combined with prolonged administration of CD40L expressing and IL-2 secreting B-CLL cells (B-CLL vaccine).
- Changes in SP tumor cell population from pre-vaccine to four weeks post-vaccination [ Time Frame: week 4 ]To determine the effects of administration of lenalidomide combined with CD40L expressing and IL-2 secreting B-CLL cells on overall disease burden and on the side population of tumor cells.
- Changes in SP tumor cell population from pre-vaccine to eight weeks post vaccination [ Time Frame: week 8 ]To determine the effects of administration of lenalidomide combined with CD40L expressing and IL-2 secreting B-CLL cells on overall disease burden and the side population of tumor cells.
- Number of patients with a tumor response post vaccination [ Time Frame: 4 weeks ]To determine the effects of administration of lenalidomide combined with CD40L expressing and IL-2 secreting B-CLL cells on overall disease burden.
- Number of patients with a tumor response post vaccination [ Time Frame: 8 weeks ]To determine the effects of administration of lenalidomide combined with CD40L expressing and IL-2 secreting B-CLL cells on overall disease burden.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604031
|United States, Texas|
|Houston Methodist Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Martha Mims, MD||Baylor College of Medicine|
|Principal Investigator:||Malcolm Brenner, MB, PhD||Baylor College of Medicine|