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

Conditions:Blood Cancer, Lymphoma, Leukemia
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:December 31, 2018
End Date:December 2021
Contact:Ariela Noy, MD

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A Phase II Clinical Trial of CPI-613 in Patients With Relapsed or Refractory Burkitt Lymphoma/Leukemia or High-grade B-cell Lymphoma With Rearrangements of MYC and BCL2 and/or BCL6

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

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

- 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.

- Central 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)

- 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
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.

- Patients must have, or be willing and eligible to undergo placement of, a working
central venous access device.

Exclusion Criteria:

- Patients that have received a chemotherapy regimen with stem cell support in the
previous 3 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

- 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

- Any condition or abnormality which may, in the opinion of the investigator, compromise
his or her safety.

- Life expectancy less than 2 months.

- Requirement for immediate palliative treatment of any kind including surgery.

- 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

- 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.

- 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

1. Patients with active graft-versus-host-disease are not eligible

2. Patients receiving immunosuppressive therapy for prevention of graft-versus-host
disease are not eligible
We found this trial at
Commack, New York 11725
Phone: 212-639-7423
Commack, NY
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Basking Ridge, New Jersey 07920
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Basking Ridge, NJ
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500 Westchester Avenue
Harrison, New York 10604
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Harrison, NY
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Middletown, New Jersey 07748
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Middletown, NJ
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225 Summit Avenue
Montvale, New Jersey 07645
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Montvale, NJ
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1275 York Ave
New York, New York 10021
(212) 639-2000
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
New York, NY
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Rockville Centre, New York 11570
Phone: 212-639-7423
Rockville Centre, NY
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