Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT01937468 |
Other study ID # |
13-281 |
Secondary ID |
R01CA183559-01 |
Status |
Active, not recruiting |
Phase |
Phase 1
|
First received |
|
Last updated |
|
Start date |
November 2013 |
Est. completion date |
December 2024 |
Study information
Verified date |
January 2024 |
Source |
Dana-Farber Cancer Institute |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This research study is a Phase I clinical trial, which tests the safety of an investigational
combination of IL-2 plus donor anti-inflammatory Treg cells and also tries to define the
appropriate dose of the investigational combination of IL-2 plus donor anti-inflammatory Treg
cells to use for further studies. IL-2 is involved with cell signaling and regulation of
white blood cells (WBCs). WBCs are part of the immune system. Treg cells are also part of the
immune system; they are involved with anti-inflammatory responses. "Investigational" means
that the combination of IL-2 and anti-inflammatory Treg cell infusion is being studied. It
also means that the FDA (U.S. Food and Drug Administration) has not approved the combination
of IL-2 and anti-inflammatory Treg cell infusion for use in people with cGVHD.
Chronic GVHD is a medical condition that may occur after you have received your bone marrow,
stem cell or cord blood transplant from a donor. The donor's immune system may recognize your
body (the host) as foreign and attempt to 'reject' it. This process is known as
graft-versus-host disease.
Traditional standard therapy to treat cGVHD is prednisone (steroids). Participants on this
trial have not responded to steroid therapy. The investigators are looking to assess the
safety and optimal dose for the combination of IL-2 plus donor anti-inflammatory Treg cells,
that may help control cGVHD by stopping the donor's immune system from 'rejecting' your body.
Description:
After the screening procedures confirm that you are eligible to participate in the research
study: If you take part in this research study, you (and your donor) will have the following
tests and procedures:
Donor Lymphocytes Collection: Lymphocytes are a type of white blood cell involved with the
immune system. Your original marrow/stem cell donor will undergo one white blood cell
collection procedures called leukapheresis. Blood from the vein in one arm will be circulated
through a special machine to remove the white blood cells, and the rest of the blood will be
returned to the donor's other arm. The cells collected from the leukapheresis will be sent to
the laboratory where the amount of white blood cells collected will be measured. A sample
will be removed for study testing, and the remaining lymphocytes will be set-aside for
infusion.
Donor Lymphocyte Processing: Once the lymphocytes are collected from your donor, the
CliniMACS System device will enrich (preferentially select) the number of Treg cells. Samples
will be taken before and after processing by the CliniMACS System to examine the cells. After
completing the necessary safety tests, the Treg-enriched donor lymphocyte cells will be ready
for administration.
Donor Cellular Infusion (DCI): The Treg-enriched donor lymphocytes will be infused through an
intravenous (I.V.) catheter over approximately 5-10 minutes. Prior to the infusion, you will
receive Tylenol and Benadryl to prevent transfusion related reactions. You will be observed
for about 1 hour after the infusion. The total anticipated time you will spend in the clinic
is approximately 2 hours.
Since the investigators are looking for the highest one-time dose of the anti-inflammatory
donor cells that can be administered safely in combination with IL-2 without severe or
unmanageable side effects in participants that have cGVHD, not everyone who participates in
this research study will receive the same dose of the donor cells. The cell dose you get will
depend on the number of participants who have been enrolled in the study before you and how
well they have tolerated their cell doses.
Study Drug: You will give yourself or be given IL-2 daily through an injection under your
skin. You will do this once every day for 8 weeks, starting from the day of donor Treg cell
infusion. You will then have 4 weeks off of IL-2.
IL-2 will be provided in single-use (one-time only) syringes to be refrigerated at home at 36
- 46°F (2 - 8°C).
During the first 6 weeks of IL-2, you will continue to take steroids and other immune
suppressing medications without changing the dose your doctor has set for you while you are
on IL-2. After 6 weeks of IL-2 therapy, your doctor may reduce the amount of steroids you
take.
If your cGVHD improves after 8 weeks on IL-2, you may have the option of continuing
extended-duration therapy. Extended-duration therapy is daily IL-2 treatment starting at the
end-of-study visit after week 12. Your doctor will discuss this option with you. If you
continue with extended-duration IL-2 therapy after completing the week 12 evaluation, you
will be assessed on the following schedule:
- Clinic visits for evaluation of toxicity and clinical benefit approximately every 4
weeks
- Immunologic assays approximately every 8 weeks. Immunologic assays will measure the
effect of IL-2 on immune cells.
Drug Diary: Each day for the first 8 weeks you take IL-2 and each day during extend-duration
IL-2 (if applicable), you will be asked to document, in a drug diary, when you took the drug
and where you injected it. The diary will also include special instructions for taking the
study drug(s). The diary will also ask if the entire syringe was injected, and if there were
other issues related to IL-2. You will be asked to return your drug diary to clinic every 14
days while you receive IL-2. If you continue taking IL-2 in the extend-duration portion, you
will return your drug diary every 8 weeks (at your clinic visit).
Chronic GVHD Assessments: While you are on study, a member of the study team will examine you
to evaluate your cGVHD. These assessments may include examination of your skin,
joints/muscles, eyes, mouth, lungs and gastrointestinal system (for example, whether you have
experienced any nausea, vomiting, diarrhea, difficulty swallowing). The investigators will
also look at the range of motion of different body parts (for example, your arms).