LymphomaPhase 2NCT03793140
A Study of CPI-613 for Patients With Relapsed or Refractory Burkitt Lymphoma/Leukemia or High-Grade B-Cell Lymphoma With High-Risk Translocations
A Phase 2 study testing CPI-613 in people with Lymphoma and Leukemia, run by Memorial Sloan Kettering Cancer Center at 11 sites in United States.
Trial summary
The purpose of this study is to test any good and bad effects of the study drug, CPI-613. Read more about this study
- Who is it for?
- Ages 12 years and older
- What is being tested?
- CPI-613
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 11 sitesUnited States
- Study dates
- 31 Dec 2018to 25 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- For patients less than 16 years of age, Lansky score ≥ 30
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- 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Massachusetts General Hospital
Boston, Massachusetts, 02114
Memorial Sloan Kettering Commack
Commack, New York, 11725
City of Hope
Duarte, California, 91010
Memorial Sloan Kettering Westchester
East White Plains, New York, 10604
Md Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Pennsylvania (Data Collection Only)
Philadelphia, Pennsylvania, 19104
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
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
The purpose of this study is to test any good and bad effects of the study drug, CPI-613.
- Being tested
- CPI-613
- Keywords
- Burkitt Lymphoma/Leukemia, high-grade B-cell lymphoma, CPI-613
- Medical subject headings
- Lymphoma, Leukemia, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPI-613Drug
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)
| Study group | Role | What they receive |
|---|---|---|
| CPI-613 | Experimental | 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]. Receives: Drug: CPI-613 |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate of CPI-613
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).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start31 Dec 2018
- Primary completion25 Aug 2026
- Study completion25 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label multicenter, single-arm, phase II trial of CPI-613 monotherapy.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- City of Hope Medical Center, Massachusetts General Hospital, M.D. Anderson Cancer Center, George Washington University
- Responsible party
- Sponsor
- Investigators
- Ariela Noy, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793140
- Sponsor's protocol ID
- 18-443
- Status last verified
- Aug 2026
- First submitted
- 2 Jan 2019
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Steiner R, Nikolaenko L, Nair R, Seshan V, Thiruvengadam SK, Khan N, Abramson JS, Horwitz S, Matasar M, Owens C, Rodriguez Rivera II, Straus DJ, Pardee TS, Luther S, Saboukoulou S, Thet WS, Vemuri S, Noy A. Novel devimistat results in complete remissions in heavily pretreated Burkitt lymphoma in a phase 2 trial. Blood Adv. 2025 Nov 11;9(21):5556-5563. doi: 10.1182/bloodadvances.2025016168.
PubMed 40674734
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03793140
- Acronym / sponsor ID
- 18-443
- Keywords
- Burkitt Lymphoma/Leukemia, high-grade B-cell lymphoma, CPI-613
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- City of Hope Medical Center, Massachusetts General Hospital, M.D. Anderson Cancer Center, George Washington University
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- 25 Aug 2026 (actual)
- Study completion
- 25 Aug 2026 (actual)
- First posted
- 4 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test any good and bad effects of the study drug, CPI-613.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label multicenter, single-arm, phase II trial of CPI-613 monotherapy.
| Arm | Type | Receives |
|---|---|---|
| CPI-613 | Experimental | Drug: CPI-613CPI-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]. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPI-613CPI-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) | Drug | CPI-613 |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Derived from this study: PubMed 40674734Steiner R, Nikolaenko L, Nair R, Seshan V, Thiruvengadam SK, Khan N, Abramson JS, Horwitz S, Matasar M, Owens C, Rodriguez Rivera II, Straus DJ, Pardee TS, Luther S, Saboukoulou S, Thet WS, Vemuri S, Noy A. Novel devimistat results in complete remissions in heavily pretreated Burkitt lymphoma in a phase 2 trial. Blood Adv. 2025 Nov 11;9(21):5556-5563. doi: 10.1182/bloodadvances.2025016168.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariela Noy, MD principal investigator
Memorial Sloan Kettering Cancer Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CPI-613 in people with Lymphoma and Leukemia, run by Memorial Sloan Kettering Cancer Center at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate of CPI-613 (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03793140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.