Clinical Trial TitleGRAVITAS-309: A phase 2/3 study of itacitinib and corticosteroids as initial treatment for chronic graft-versus-host disease: Part 2.
National Clinical Trial Number:NCT03584516
Clinical Trial Protocol Description:
When a patient receives a donor’s stem cells during an allogeneic bone marrow transplant (stem cells removed from a donor), the stem cells recreate the donor’s immune system in the patient’s body (“the host”). A common side effect of an allo-hematopoietic stem cell transplant (HSCT) is Graft-Versus-Host Disease (GVHD). It occurs when the new immune system from the donor attacks the host’s body. The donor cells see the host’s cells as “foreign” and attack them, which causes damage. There are two types of GVHD. Acute GVHD usually develops in the first 100 days or so after the bone marrow transplant. Chronic GVHD (cGVHD) usually develops 3-6 months after the transplant, but signs can appear earlier or later. This can be from acute GVHD progressing to the chronic stage.
Itacitinib is a potent and selective inhibitor of the Janus kinase (JAK) family of the protein tyrosine kinases (TYKs) with selectivity for JAK1. Inhibition of tyrosine kinases activity using small molecules has recently become a powerful tool for treatment of several cancers. It is also being studied by Incyte Corporation for use in the treatment of moderate or severe cGVHD.
The purpose of this study is to assess how safe and well tolerated itacitinib is in combination with corticosteroids compared to placebo in patients who have cGVHD. This study has 3 parts, Part 1, Part 1 Expansion, and Part 2. Part 1 of this study is closed to enrollment. You would be participating in Part 2.
Part 2 is a randomized (subjects are randomly assigned), double-blind, placebo-controlled design to receive the investigational combination (itacitinib + corticosteroids) or corticosteroids + placebo to evaluate the effectiveness of itacitinib treatment. A double-blind study means that neither the participating subject nor the study doctor will know which treatment the subject is receiving, but the study doctor can find out quickly from the Sponsor if necessary. Placebo looks like the study drug but contains no medication.
Participation in Part 2 of the study will last for approximately 36 months as long as the doctor feels the participating subject is benefiting from study treatment and is not having any severe side effects.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have been diagnosed with moderate or severe chronic GVHD.
- Have had an allogeneic bone marrow transplant.
- Are able to swallow pills.
You will be excluded from the study if any of the following criteria apply to you:
- Have had more than 1 allogeneic bone marrow transplant procedure. Patients who have received a prior autologous HSCT can join.
- Have received more than 3 days of systemic corticosteroid treatment for your cGVHD.
- Have received prior treatment with a JAK inhibitor within 8 weeks before randomization.
- Have an active uncontrolled bacterial, fungal, parasitic or viral infection.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.