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Must be ≥ 18 years of age |
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Histologic diagnosis of Burkitt Lymphoma/Leukemia or high-grade B-cell lymphoma with rearrangements of MYC and BCL2 and/or BCL6 confirmed at enrolling institution |
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Failure of at least one previous line of therapy |
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Failure after prior bone marrow transplant, or ineligible for or opted not to participate in bone marrow transplantation for Burkitt Lymphoma/Leukemia, or DHL/THL |
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ECOG Performance Status of ≤ 3 |
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Measurable disease as defined RECIL criteria (2017) or isolated bone marrow involvement |
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Patients must have fully recovered from the acute, non-hematological, non-infectious toxicities of any prior treatment with anti-cancer drugs, radiotherapy or other anti-cancer modalities. Patients with persistent, non-hematologic, non-infectious toxicities from prior treatment must have documented resolution to ≤ Grade 2 |
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Patients must have, or be willing and eligible to undergo placement of, a working central venous access device |
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Venous access available (e.g., portacath, PICC line or equivalent) |
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Laboratory values obtained ≤ 2 weeks prior to enrollment must demonstrate adequate hepatic function, renal function, and coagulation as defined below |
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Aspartate aminotransferase (AST/SGOT) ≤ 5x upper normal limit (ULN) |
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Alanine aminotransferase (ALT/SGPT) ≤ 5x ULN |
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Total bilirubin ≤1.5x ULN (unless related to hemolysis or Gilbert's syndrome, or involvement by lymphoma; if involvement by lymphoma: total bilirubin </= 3.0 x ULN) |
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Creatinine clearance >=40cc min either by 24-hour creatinine clearance or calculated from the modified Cockcroft-Gault equation (with the use of ideal body mass [IBM] instead of mass): CRCL =(140-Age) × IBM (kg) × [0.85 if female]/[(72 • serum creatinine (mg/dL)] |
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International Normalized Ratio (INR) must be <1.5. Due to the occurrence of thrombocytopenia, patients should not enter with coagulopathy. Patients on anticoagulants should be on short-acting therapy (e.g. low molecular weight heparin) rather than oral anticoagulants |
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Albumin ≥2.0 g/dL (or ≥20 g/L) |
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Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically |
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Females must agree to abstain from breastfeeding during study participation |
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sterile) must use accepted contraceptive methods (abstinence, intrauterine |
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device [IUD], oral contraceptive or double barrier device) during the study |
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Fertile men must practice effective contraceptive methods during the study unless documentation of infertility exists |
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and must have a negative serum or urine pregnancy test within 2 weeks prior to |
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treatment initiation |
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Patients that have received a chemotherapy regimen with stem cell support in the previous 2 months
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Any medical condition that is clinically unstable despite present therapy (i.e. uncontrolled infection)
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Platelets < 50,000/mm3 unless attributable to marrow based (either Burkitt lymphoma or DHL/THL.) Note: Patients with leukemia/lymphoma in the marrow 25,000-50,000 will be assessed for grade 4 thrombocytopenia unless they have platelet recovery above grade 3\. Patients entering with platelets <25,000 will only be assessed for thrombocytopenia related to drug if they recover to grade 3 or higher
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Serious medical illness, such as significant cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, coronary artery disease, myocardial infarction within the past 3 months, uncontrolled cardiac arrhythmia, pericardial disease or New York Heart Association Class III or IV), or severe debilitating pulmonary disease, that would potentially increase patient's risk for toxicity
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Patients with active central nervous system (CNS) parenchymal disease. Patients with leptomeningeal disease are allowed as long as the CSF has cleared for more than 4 weeks and the patient is receiving maintenance intrathecal/intra Ommaya therapy
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Any active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease)
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Any condition or abnormality which may, in the opinion of the investigator, compromise his or her safety
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HIV patients with any of the following: a) uncontrolled HIV infection defined as an HIV viral load > 100K copies/mL, b) a documented opportunistic infection within the last 90 days, c) concurrent HIV therapy with zidovudine or any strong CYP3A4 inhibitor (e.g. ritonavir or cobicistat) within 7 days of study drug due to potential drug-drug interaction
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Patients who have received radiotherapy, surgery, treatment with cytotoxic agents, treatment with biologic agents, immunotherapy , or any other anti-cancer therapy for any kind for cancer, or any other investigational agent for any indication, within the past 2 weeks prior to initiation of CPI-613 treatment with the exclusion of radiation to one area (e.g. whole brain or involved nodal site) that does not interfere with response assessment in other sites. A course of steroids (up to 14 days total) prior to study initiation is acceptable
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Psychiatric illness or social situation that would limit the patient's ability to tolerate and/or comply with study requirements
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Prior allogeneic stem cell transplant within 2 months of study start
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Patients with active graft-versus-host-disease are not eligible
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Patients receiving immunosuppressive therapy for prevention of graft-versus-host disease are not eligible
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