Evaluation of Fostamatinib in Patients With cGVHD After Allogeneic Stem Cell Transplant

Completed · Phase 1

Conditions studied: Hematological Malignancies

In brief

The purpose of this study is to evaluate whether fostamatinib, a drug that blocks activated B cells will be effective in preventing and treating chronic graft vs host disease (cGVHD) after allogeneic stem cell transplant. Activated B cells may play a role in development of cGVHD. Inhibiting the B cell activation using fostamatinib after allogeneic stem cell transplant may prevent the development of cGVHD.

Key facts

Study ID

NCT02611063

Run by

Stefanie Sarantopoulos, MD, PhD.

People needed

22

Starts

2016-01-01

Expected to finish

2022-02-22

Last updated by the study team

2023-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have undergone allogeneic stem cell transplantation for the treatment of any hematological malignancy are eligible. Transplant must have occurred 90 days before the start of study drug.
• Peripheral blood stem cells must have been used as the stem cell source.
• Patients must have received transplantation from adult donors (both related and unrelated) who are Human Leukocyte Antigen (HLA) matched or mismatched at 1 locus (5/6) or are mismatched at one allele (3/6). Class I and II typing is to be performed by standard methods at our institution.
• Complete remission of hematological malignancy prior to transplantation. All patients must have undergone appropriate staging for their malignancy prior to transplantation including bone marrow aspirate/biopsy and radiographic scanning if indicated.
• Patients who have undergone a non-myeloablative stem cell transplant must have > 65% donor lymphoid hematopoiesis within 30 days of study enrollment.
• Patient age greater than 18 years of age.
• ECOG performance status 0-2 or Karnofsky Performance Status (KPS) > 60.
• Must be able to tolerate routine oral posaconazole or voriconazole as fungal prophylaxis therapy.
• Written informed consent.

You may not qualify if…

• Recipients of allogeneic stem cell transplantation using a single or multiple umbilical cord blood units or using bone marrow.
• Participation in a clinical trial evaluating another preventative strategy for chronic GVHD or ongoing participation in a clinical trial for therapy of acute GVHD. Prior completion of experimental therapy for acute GVHD is permissible if the experimental agent was used > 14 days prior to enrollment.
• Evidence of relapsed hematologic malignancy based on routine restaging studies.
• Evidence of any active uncontrolled infection (bacterial, viral or fungal) or evidence of natural exposure to Hepatitis B, Hepatitis C or HIV without demonstration of PCR negativity for said virus. Vaccination to Hepatitis B is not an exclusion criterion.
• Any evidence of ongoing gastrointestinal or hepatic acute GVHD or evidence of greater than ongoing Stage I cutaneous acute GVHD at time of enrollment. Ongoing, tapering therapy for resolved acute GVHD is permissible.
• Patients with GVHD with chronic features diagnosed prior to day +60 or prior to enrollment are ineligible.
• Patients may have received no more than one Donor Lymphocyte Infusion (DLI), DLI must have been administered > 6 weeks prior to enrollment on study, and no plans for a DLI in the upcoming 30 days.
• Any major cardiovascular even within 6 months of study initiation, including but not limited to myocardial infarction, unstable angina, cerebrovascular accident, pulmonary embolism, heart failure uncontrolled by medications or New York Heart Association Class III or IV heart failure.
• Uncontrolled or poorly controlled hypertension, defined as systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg, whether or not the subject is receiving anti-hypertensive treatment. Subjects may be rescreened if the blood pressure is successfully and promptly controlled within 5 days using conventional anti-hypertensive therapy to achieve optimal blood pressure control (<140/90 mmHg).
• Active hemolytic anemia.
• History of arterial or venous thrombosis (unless a single episode of venous thrombosis > 1 year prior to study initiation).
• Liver function test abnormalities including ALT or AST > 3.0x ULN; total bilirubin > 1.5x ULN; alkaline phosphatase > 2.5 x ULN
• Neutrophil count < 1.5 x 10e9/L or platelet count < 75 x10e9/L
• Pregnancy or lactation.

Where it is running

• Duke University of Medicine — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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