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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03793140
Recruitment Status : Recruiting
First Posted : January 4, 2019
Last Update Posted : June 17, 2019
Sponsor:
Collaborators:
City of Hope Medical Center
Massachusetts General Hospital
M.D. Anderson Cancer Center
George Washington University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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

Condition or disease Intervention/treatment Phase
Lymphoma Leukemia Drug: CPI-613 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is an open-label multicenter, single-arm, phase II trial of CPI-613 monotherapy.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 31, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia Lymphoma

Arm Intervention/treatment
Experimental: CPI-613
CPI-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].
Drug: CPI-613
CPI-613 [2,500 mg/m2/day IV] over 2 hours (+/- 10 mins) Induction tx: Cycle 1 and 2: Treatment on Days 1-5 (Each cycle is 14 days). (Each Cycle is 14 days) Maintenance tx: All subsequent Cycles: Treatment with CPI-613 [2,500 mg/m2/day IV] over 2 hours (+/- 10 mins) on Days 1-5 (Each Cycle is 21 days)




Primary Outcome Measures :
  1. overall response rate of CPI-613 [ Time Frame: 3 years ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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)
    • 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.

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..
  • 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 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

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793140


Contacts
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Contact: Ariela Noy, MD 212-639-7423 noya@mskcc.org
Contact: Anita Kumar, MD 212-639-2668

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Liana Nikolaenko, MD    800-826-4673      
United States, District of Columbia
George Washington University Medical Center Not yet recruiting
Washington, District of Columbia, United States, 20037
Contact: Kieron Dunleavy, MD    202-741-2210      
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Jeremy Abramson, MD    617-724-4000      
United States, New Jersey
Memorial Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Ariela Noy, MD    212-639-7423      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Ariela Noy, MD    212-639-7423      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Ariela Noy, MD    212-639-7423      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Ariela Noy, MD    212-639-7423      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Ariela Noy, MD    212-639-7423      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Ariela Noy, MD    212-639-7423      
Contact: Anita Kumar, MD    212-639-2668      
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Ariela Noy, MD    212-639-7423      
United States, Texas
Md Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Raphael Steiner, MD         
Contact    713-792-6161      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
City of Hope Medical Center
Massachusetts General Hospital
M.D. Anderson Cancer Center
George Washington University
Investigators
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Principal Investigator: Ariela Noy, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03793140     History of Changes
Other Study ID Numbers: 18-443
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Burkitt Lymphoma/Leukemia
high-grade B-cell lymphoma
CPI-613
Additional relevant MeSH terms:
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Burkitt Lymphoma
Lymphoma
Leukemia
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections