Acute Lymphoblastic Leukemia Clinical Trial
— IL2 for GVHDOfficial title:
Phase II Trial Using Low Dose IL-2 to Induce Regulatory T Cells in Patients After Allogeneic Hematopoietic Stem Cell Transplantation as Graft Versus Host Disease Prophylaxis
Verified date | April 2018 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients are being asked to participate in this study because treatment for their disease
requires a stem cell transplant (SCT). Stem cells are the source of normal blood cells found
in the bone marrow and lead to recovery of blood counts after bone marrow transplantation.
With stem cell transplants, regardless of whether the donor is a full match to the patient or
not, there is a risk of developing graft-versus-host disease (GVHD).
GVHD is a serious and sometimes fatal side effect of SCT. GVHD occurs when the new donor stem
cells (graft) recognizes that the body tissues of the patient (host) are different from those
of the donor. When this happens, cells in the graft may attack the host organs. How much this
happens and how severe the GVHD is depends on many things, including how different the donors
cells are, the strength of the drugs given in preparation for the transplant, the quality of
transplanted cells and the age of the person receiving the transplant.
Typically, acute GVHD occurs in the first 100 days following transplant, while chronic GVHD
occurs after day 100. Acute GVHD most often involves the skin, where it can cause anywhere
from a mild rash to complete removal of skin; liver, where it can anywhere from a rise in
liver function tests to liver failure; and the gut, where it can cause anywhere from mild
diarrhea to profuse, life-threatening diarrhea. Most patients who develop GVHD experience a
mild to moderate form, but some patients develop the severe, life-threatening form.
Previous studies have shown that patients who receive SCT's can have a lower number of
special T cells in their blood, called regulatory T cells, than people who have not received
stem cell transplants. When regulatory T cells are low, there appears to be an increased rate
of severe, acute GVHD. A drug known as IL-2 (Proleukin) has been shown to increase the number
of regulatory T cells in patients following stem cell transplant, and in this study
investigators plan to give low dose IL-2 after transplant.
This study is called a phase II study because its major purpose is to find out whether using
a low-dose of IL-2 will be effective in preventing acute GVHD. Other important purposes are
to find out if this treatment helps the patient's immune system recover regulatory T cells
faster after the transplant. This study will assess the safety and toxicity of low-dose IL-2
given to patients after transplantation and determine whether this drug is helpful in
preventing GVHD.
Status | Completed |
Enrollment | 25 |
Est. completion date | March 2014 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 70 Years |
Eligibility |
INCLUSION CRITERIA: INCLUSION CRITERIA FOR INITIAL STUDY ENROLLMENT: Patients will be eligible for initial enrollment on this study as long as they meet the following criteria: - Diagnosis of acute lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, myelodysplastic syndrome, myeloproliferative disorder, Hodgkin lymphoma, non-Hodgkin lymphoma or non-malignant disease requiring allogeneic HSCT - Birth to age 70 years of age - Study entry consent is signed and faxed to Research Coordinator INCLUSION CRITERIA AT TIME OF IL-2 ADMINISTRATION: - At least day +7 post transplant - Less than or equal to 30 days post transplant - Lansky or Karnofsky score greater than or equal to 50% - Total bilirubin less than or equal to 1.5mg/dL - Alanine aminotransferase level (ALT) less than or equal to five times normal, serum direct bilirubin less than or equal to 1.5mg/dL, albumin greater than or equal to 3.0gm/dL - Serum creatinine less than three times normal or creatinine clearance greater than 80mg/min/1.73m2 - Ensure that informed consent signed and faxed to Research Coordinator EXCLUSION CRITERIA: EXCLUSION CRITERIA AT TIME OF IL-2 ADMINISTRATION: Patients will be ineligible to receive IL-2 injections if any of the following is true: - Active, acute GVHD greater than or equal to grade II - Serious, active bacterial, fungal or viral infection (i.e. intensive care) - Clinical Signs of severe pulmonary dysfunction - Clinical Signs of sever cardiac dysfunction - Receiving corticosteroids as GVHD treatment - Hypersensitivity or allergy to IL-2 |
Country | Name | City | State |
---|---|---|---|
United States | Texas Children's Hospital | Houston | Texas |
United States | The Methodist Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital, The Methodist Hospital System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Ancillary Studies | To conduct ancillary studies on those patients to investigate before, during and after IL-2 administration to determine: The immunophenotype of PBMCs The suppressive activity of CD4+ CD25+ FoxP3+ Tregs Cytokines secreted by PBMCs NK cell analysis |
12 weeks | |
Primary | Rate of Dose Limiting Toxicities | Assessment of the safety and the toxicity of low-dose IL-2, administered according to the dosage described in this protocol, in this group of patients The outcome measure is the proportion of participants with dose limiting toxicities. | 6-12 weeks | |
Secondary | Rate of Severe (Grade III or IV) Acute GVHD | To determine the efficacy of low-dose IL-2 in the prevention of severe (grade III or IV) acute GVHD | Up to 12 weeks on low-dose IL-2 | |
Secondary | Percentage Change in CD4+ CD25+ FoxP3+ Regulatory T Cells (Tregs) From Pre to Post IL-2 Infusions | To investigate the immunomodulatory effects of IL-2 administered after allogeneic hematopoietic stem cell transplantation | 12 weeks |
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