Clinical Trials /

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

NCT03793140

Description:

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

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
  • Burkitt Leukemia
  • Burkitt Lymphoma
  • Double-Hit Lymphoma
  • Triple-Hit Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 18-443
  • NCT ID: NCT03793140

Conditions

  • Lymphoma
  • Leukemia

Interventions

DrugSynonymsArms
CPI-613CPI-613

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
CPI-613ExperimentalCPI-613 IV induction (Days 1-5 for first 2 Cycles [14-day cycles]), followed by CPI-613 IV maintenance (Days 1-5 for all Cycles thereafter [21-day cycles].
  • CPI-613

Eligibility Criteria

        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.

          -  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
             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.

          -  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
             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.

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:overall response rate of CPI-613
Time Frame:3 years
Safety Issue:
Description:ORR will be defined as rate of complete response (CR) + partial response (PR) + minor response (MR) + Stable disease (SD) as determined as per the RECIL criteria. RECIL criteria for response assessment in lymphoma and/or bone marrow biopsy (depending on sites of disease as indicated by treating physician).

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Burkitt Lymphoma/Leukemia
  • high-grade B-cell lymphoma
  • CPI-613

Last Updated