Sitagliptin for Prevention of Acute Graft Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

Completed · Phase 2

Conditions studied: Graft vs Host Disease, Hematopoietic Stem Cell Transplantation

In brief

Primary Objective Evaluate the efficacy of sitagliptin in reducing the incidence of grade II-IV acute Graft Versus-Host Disease (GvHD) by day +100 post-transplant in patients undergoing allogeneic hematopoietic stem cell transplantation and receiving standard sirolimus and tacrolimus GvHD prophylaxis. Secondary Objectives The following descriptive secondary objectives will be studied: 1. Describe the tolerability and potential toxicity of sitagliptin. 2. Describe the cumulative incidence of grades II-IV acute GvHD by day +100. 3. Describe the cumulative incidence of grades III-IV acute GvHD. 4. Describe the engraftment kinetics of absolute neutrophil count and platelets. 5. Describe the incidence of infections occurring during the 100 days post-transplant. 6. Describe non-relapse mortality (NRM) at day +30, +100, and 1 year post-transplant. 7. Describe overall survival. 8. Describe the incidence of chronic GvHD. 9. Describe the cumulative incidence of relapse of the primary hematological malignancy.

Key facts

Study ID

NCT02683525

Run by

Sherif S. Farag

People needed

37

Starts

2016-02-03

Expected to finish

2019-10-01

Last updated by the study team

2021-01-22

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A. Patients with any of the following hematologic malignancies:
• Acute myeloid leukemia (AML) with any of the following:
• In first remission (CR1) with intermediate risk or high-risk cytogenetic and/or molecular features.
• Patients in second or subsequent complete remission (CR2, CR3, etc.).
• Primary refractory or relapsed AML with no more than any one of the following adverse additional features according to modified CIBMTR criteria:49
• Duration of first CR < 6 months
• Poor risk cytogenetics or molecular features (FLT-3 internal tandem duplication (ITD); complex karyotype with ≥3 clonal abnormalities, 5q-/-5, 7q-/-7, 11q23 abnormalities, inv(3), monosomal karyotype)
• Circulating peripheral blood blasts at time of enrollment
• Karnofsky performance status <90%
• Acute lymphoblastic leukemia (ALL) with any of the following:
• In CR1 or subsequent complete remission (CR2, CR3, etc.)
• Primary refractory or relapsed ALL with no more than one of the following adverse features according to modified CIBMTR criteria:49
• Second or subsequent relapse
• Bone marrow blasts >25% at time of enrollment
• Age >40 years
• Myelodysplasia with any of the following features:
• Refractory anemia with excess blasts type I (5-10% blasts) or II (11-20% blasts) in the bone marrow (RAEB I and II)
• Refractory cytopenia with multilineage dysplasia (RCMD) and poor risk cytogenetics (i.e., chromosome 7 abnormalities or complex karyotype with at least 3 abnormalities per clone)
• Chronic myelogenous leukemia (CML) with one of the following criteria:
• Accelerated phase, defined by any of the following:
• Blasts 10-19% in peripheral blood white cells or bone marrow
• Peripheral blood basophils at least 20%
• Persistent thrombocytopenia (<100 x 109/l) unrelated to therapy, or persistent thrombocytosis (>1000 x 109/l) unresponsive to therapy
• Increasing spleen size and increasing white blood cell (WBC) count unresponsive to therapy
• Cytogenetic evidence of clonal evolution (i.e., the appearance of an additional genetic abnormality that was not present in the initial specimen at the time of diagnosis of chronic phase)

You may not qualify if…

• A. Symptomatic uncontrolled coronary artery disease or congestive heart failure
• B. Severe hypoxemia with room air PaO2 < 70, supplemental oxygen dependence, or DLCO < 50% predicted
• C. Patients with active central nervous system involvement
• D. Prior allogeneic or autologous hematopoietic stem cell transplant in past 12 months
• E. Patients with diabetes mellitus requiring insulin secretagogues and/or insulin
• F. Patients with hypertriglyceridemia with serum triglyceride level ≥500 mg/d (lipid lowering drugs may be used to control level)
• G. Patients with a history of pancreatitis
• H. Patients with symptomatic cholelithiasis
• I. Patients with a current dependence on alcohol (characterized by a physical addiction to alcohol that interferes with physical or mental health, and social, family or job responsibilities)

Where it is running

• Indiana University Health Hospital — Indianapolis, Indiana, United States
• Indiana University Health Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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