NCT03793140

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

Active, enrolled Phase 2 Last updated 23 March 2026

What this trial tests

Phase 2 trial testing CPI-613 in Lymphoma in 24 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

31 December 2018

Primary endpoint
1 December 2026

1 December 2026

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	31 December 2018
Primary completion	1 December 2026
Estimated completion	1 December 2026
Sites	11 locations across United States

Drugs / interventions tested

• CPI-613

Conditions studied

• Lymphoma — all drugs for Lymphoma →
• Leukemia — all drugs for Leukemia →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

12 and older, any sex, with Lymphoma or Leukemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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).

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tumor biomarkers for diagnosis, prognosis and targeted therapy.
   Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
2. Cancer metabolism and carcinogenesis.
   Yang J, Shay C, Saba NF, Teng Y. · · 2024 · cited 73× · PMID 38287402 · DOI 10.1186/s40164-024-00482-x
3. DLST-dependence dictates metabolic heterogeneity in TCA-cycle usage among triple-negative breast cancer.
   Shen N, Korm S, Karantanos T, Li D, et al · · 2021 · cited 51× · PMID 34785772 · DOI 10.1038/s42003-021-02805-8
4. Can Metabolic Pathways Be Therapeutic Targets in Rheumatoid Arthritis?
   Sanchez-Lopez E, Cheng A, Guma M. · · 2019 · cited 41× · PMID 31137815 · DOI 10.3390/jcm8050753
5. Targeting 2-oxoglutarate dehydrogenase for cancer treatment.
   Chang LC, Chiang SK, Chen SE, Hung MC. · · 2022 · cited 31× · PMID 35530286
6. Understanding and Targeting Apoptotic Pathways in Ovarian Cancer.
   Al-Alem LF, Baker AT, Pandya UM, Eisenhauer EL, et al · · 2019 · cited 28× · PMID 31652965 · DOI 10.3390/cancers11111631
7. Metabolic Reprogramming and Potential Therapeutic Targets in Lymphoma.
   Pang Y, Lu T, Xu-Monette ZY, Young KH. · · 2023 · cited 16× · PMID 36982568 · DOI 10.3390/ijms24065493
8. Metabolic cross-talk within the bone marrow milieu: focus on multiple myeloma.
   Oudaert I, Van der Vreken A, Maes A, De Bruyne E, et al · · 2022 · cited 13× · PMID 36050788 · DOI 10.1186/s40164-022-00303-z