Sheddase Inhibitor INCB007839 and Rituximab after Autologous Hematopoietic Stem Cell Transplant in Treating Patients with Diffuse Large B Cell Lymphoma

Inclusion Criteria

• Patients who have undergone an autologous HCT for the treatment of DLBCL and are in a complete remission (CR), partial remission (PR) or have stable disease (SD) at the day 28 post-transplant reassessment
• Karnofsky score of >= 70%
• Able to start the protocol therapy (1st dose of rituximab) between day 28-75 post-transplant
• Platelets >= 50,000 x 10^9/L
• Absolute neutrophil count (ANC) >= 1000 x 10^9/L unsupported by granulocyte-stimulating growth factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) for 3 days
• Creatinine < 1.5 mg/dl or glomerular filtration rate > 50 ml/min
• Alanine transaminase (ALT, serum glutamate pyruvate transaminase [SGPT]) and aspartate aminotransferase (serum glutamic oxaloacetic transaminase [SGOT], AST) < 3 x upper limit of institutional normal
• Total bilirubin < 3.0 mg/dl (if total bilirubin is >= 3.0 patient is eligible if direct bilirubin is within normal limits)
• Clinically no evidence of pulmonary disease
• No symptoms of uncontrolled cardiac disease
• If post-transplant consolidation radiation therapy is given, the patient must be at least 14 days between last radiation treatment and 1st dose of rituximab
• Able to take daily aspirin (325 mg) for the duration of INCB7839 treatment and 1 week after the last dose to reduce the risk of thrombosis (not applicable if on other anti-coagulant therapy at time of study enrollment)
• Females are either postmenopausal for at least 1 year, are surgically sterile for at least 3 months, or must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through 12 months after the last dose of rituximab if of childbearing potential; (Note: permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed)
• Males must agree to take appropriate precautions to avoid fathering a child (with at least 99% certainty) from screening through 12 months after the last dose of rituximab; (Note: permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed)
• Voluntary written consent signed before performance of any study-related procedure not part of normal medical care

Exclusion Criteria

• Pregnant or lactating - women of childbearing potential should use appropriate precautions to avoid becoming pregnant; females of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study treatment start
• Recent venous thrombosis within 4 weeks prior to study enrollment; patients at high risk for thrombotic events due to inherited risk factors (i.e. factor V Leiden) or deep vein thrombosis (DVT)/pulmonary embolism (PE) in the past 12 months should be on secondary prophylaxis with anti-coagulant therapy (i.e. warfarin or low molecular weight heparin) prior to enrollment
• Active uncontrolled infection
• Active central nervous system (CNS) disease
• Previous severe or life-threatening allergic reaction with rituximab or known allergy to the compounds found in INCB7839
• Any gastrointestinal condition causing malabsorption or obstruction (e.g., celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)
• Unwilling or unable to swallow tablets BID
• Serologic or clinical evidence of current active hepatitis B or C infection, defined as elevated levels of hepatitis (Hep) B antigen or Hep C antibody (unless active infection is ruled out by nucleic acid tests)
• Human immunodeficiency virus (HIV) infection