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

  • End date
    Dec 5, 2023
  • participants needed
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 5 February 2022
bone marrow transplant
measurable disease
bone marrow procedure
b-cell lymphoma


The purpose of this study is to test any good and bad effects of the study drug, CPI-613.

Condition Lymphoma, Leukemia
Treatment CPI-613
Clinical Study IdentifierNCT03793140
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on5 February 2022


Yes No Not Sure

Inclusion Criteria

Must be ≥ 18 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
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
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)]
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
Females must agree to abstain from breastfeeding during study participation
sterile) must use accepted contraceptive methods (abstinence, intrauterine
device [IUD], oral contraceptive or double barrier device) during the study
Fertile men must practice effective contraceptive methods during the study unless documentation of infertility exists
and must have a negative serum or urine pregnancy test within 2 weeks prior to
treatment initiation

Exclusion Criteria

Patients that have received a chemotherapy regimen with stem cell support in the previous 2 months
Any medical condition that is clinically unstable despite present therapy (i.e. uncontrolled infection)
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
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
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
Any active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease)
Any condition or abnormality which may, in the opinion of the investigator, compromise his or her safety
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
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
Psychiatric illness or social situation that would limit the patient's ability to tolerate and/or comply with study requirements
Prior allogeneic stem cell transplant within 2 months of study start
Patients with active graft-versus-host-disease are not eligible
Patients receiving immunosuppressive therapy for prevention of graft-versus-host disease are not eligible
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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