A Study of CPI-613 for Patients With Relapsed or Refractory Burkitt Lymphoma/Leukemia or High-Grade B-Cell Lymphoma With High-Risk Translocations

Inclusion Criteria

• •Must be ≥ 12 years of age.
• •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 or plasmablastic lymphoma or high-grade B-cell lymphoma with rearrangements of MYC without bcl-2
• •Failure of at least one previous line of therapy.
• •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.
• •ECOG Performance Status of ≤ 3.
• •1. For patients less than 16 years of age, Lansky score ≥ 30
• •2. For patients 16- 17 years of age, Karnofsky score ≥ 30
• •Measurable disease as defined RECIL criteria (2017) or isolated bone marrow involvement.
• •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.
• •Patients must have, or be willing and eligible to undergo placement of, a working central venous access device
• •Venous access available (e.g., portacath, PICC line or equivalent).
• •Laboratory values obtained ≤ 2 weeks prior to enrollment must demonstrate adequate hepatic function, renal function, and coagulation as defined below:
• •* Aspartate aminotransferase (AST/SGOT) ≤ 5x upper normal limit (ULN)
• •* Alanine aminotransferase (ALT/SGPT) ≤ 5x ULN
• •* 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)
• •* 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) × \[0.85 if female\]/\[(72 • serum creatinine (mg/dL)\]
• •* For patients less than 16 years of age, the Bedside Schwartz equation or Creatinine-Cystatin C-based CKiD equation should be used for creatinine-based GFR calculation
• •* 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.
• •* Albumin ≥2.0 g/dL (or ≥20 g/L)
• •Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive or double barrier device) during the study and must have a negative serum or urine pregnancy test within 2 weeks prior to treatment initiation.
• •Females must agree to abstain from breastfeeding during study participation
• •Fertile men must practice effective contraceptive methods during the study unless documentation of infertility exists.