NCT03793140

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_2 lymphoma

Timeline
7mo left

Started Dec 2018

Typical duration for phase_2 lymphoma

Geographic Reach
1 country

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Dec 2018Dec 2026

Study Start

First participant enrolled

December 31, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

7.9 years

First QC Date

January 2, 2019

Last Update Submit

March 23, 2026

Conditions

LymphomaLeukemia

Keywords

Burkitt Lymphoma/Leukemiahigh-grade B-cell lymphomaCPI-613

Outcome Measures

Primary Outcomes (1)

  • 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).

    3 years

Study Arms (1)

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 \[21-day cycles\].

Drug: CPI-613

Interventions

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)

CPI-613

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)
  • +7 more criteria

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

City of Hope

Duarte, California, 91010, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

University of Pennsylvania (Data Collection Only)

Philadelphia, Pennsylvania, 19104, United States

Location

Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 40674734DERIVED

Related Links

MeSH Terms

Conditions

LymphomaLeukemiaBurkitt Lymphoma

Interventions

devimistat

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-Hodgkin

Study Officials

  • Ariela Noy, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is an open-label multicenter, single-arm, phase II trial of CPI-613 monotherapy.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 4, 2019

Study Start

December 31, 2018

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
SAP, ICF

Locations

US(11)