CPI-613 for Lymphoma

Not currently recruiting at 10 trial locations

Overseen By Anita J Kumar

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Oral anticoagulants, Strong CYP3A4 inhibitors

Disqualifiers: Uncontrolled infection, Cardiac disease, CNS disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effects of CPI-613, a new drug, on individuals with certain types of lymphoma, including Burkitt Lymphoma and high-grade B-cell lymphoma. The researchers aim to determine how well CPI-613 works and identify any side effects it might cause. Participants who have tried at least one other treatment without success and have measurable disease or bone marrow involvement may be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients should not be on certain oral anticoagulants and should avoid strong CYP3A4 inhibitors like ritonavir or cobicistat within 7 days of the study drug. It's best to discuss your current medications with the study team.

Is there any evidence suggesting that CPI-613 is likely to be safe for humans?

Research has shown that CPI-613 has a promising safety record in previous studies. For instance, one study found that CPI-613 was well-tolerated when combined with other cancer treatments like gemcitabine and nab-paclitaxel. Patients safely received doses up to 1,500 mg/m², indicating that CPI-613 can be used without causing severe side effects.

Another study examined the highest safe dose and safety of CPI-613 when combined with mFOLFIRINOX, a treatment for pancreatic cancer. The results confirmed the safety of CPI-613, with manageable side effects.

These findings provide some confidence in the safety of CPI-613 for patients. However, treatments can affect people differently. It is crucial to consult healthcare providers to understand the risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

CPI-613 is unique because it targets the energy metabolism of cancer cells, unlike typical lymphoma treatments that primarily focus on directly attacking the cancer cells or modulating the immune system. This treatment works by disrupting the mitochondrial tricarboxylic acid (TCA) cycle, which is crucial for cancer cell survival and growth. Researchers are excited about CPI-613 because this novel mechanism could potentially overcome resistance seen in traditional therapies and offer a new pathway to treat lymphoma that other drugs haven't tapped into yet.

What evidence suggests that CPI-613 might be an effective treatment for lymphoma?

Research has shown that CPI-613, the investigational treatment in this trial, may help treat certain types of cancer. In an earlier study, a patient with a hard-to-treat form of lymphoma experienced partial tumor shrinkage for over a year after using CPI-613. Another study found that CPI-613 increased the response rate, with 53.9% of patients responding compared to 31.6% without it. While some patients' conditions remained stable, the average time they lived without disease progression was about 2.3 months. These findings suggest that CPI-613 could benefit some lymphoma patients, but results can vary. ^{6 7 8 9 10}

Who Is on the Research Team?

Ariela Noy, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients aged 12 or older with relapsed/refractory Burkitt Lymphoma/Leukemia, high-grade B-cell lymphoma with high-risk translocations, and adequate organ function. Participants must not have HIV complications, recent allogeneic stem cell transplant, uncontrolled conditions, or recent other cancer treatments. Women of childbearing potential must use contraception and have a negative pregnancy test.

Inclusion Criteria

Venous access available (e.g., portacath, PICC line or equivalent)

Fertile men must practice effective contraceptive methods during the study unless documentation of infertility exists

My kidney function was checked using a specific method because I am under 16.

Exclusion Criteria

Any condition or abnormality which may, in the opinion of the investigator, compromise his or her safety

You have a mental health condition or a difficult living situation that may make it hard for you to follow the study rules.

I had chemotherapy with stem cell support in the last 2 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

CPI-613 IV induction on Days 1-5 for the first 2 Cycles (14-day cycles)

4 weeks

Maintenance Treatment

CPI-613 IV maintenance on Days 1-5 for all Cycles thereafter (21-day cycles)

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

• CPI-613

Trial Overview The study is testing the effects of CPI-613 on individuals with specific types of lymphomas and leukemias that are resistant to previous treatments. The drug's effectiveness as well as any adverse reactions will be monitored throughout the trial.

How Is the Trial Designed?

Group I: CPI-613 Experimental Treatment 1 Intervention

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 \[21-day cycles\].

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

George Washington University

Collaborator

Trials

263

Recruited

476,000+

City of Hope Medical Center

Collaborator

Trials

614

Recruited

1,924,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6854438/

A Phase III open-label trial to evaluate efficacy and safety of ... Efficacy evaluations​​ The primary objectives of the study are to evaluate ORR and PFS of CPI-613 plus mFFX compared with that of FFX (control ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0006497118620154

A Phase II Clinical Trial of Cpi-613 (devimistat) in Patients ... In the initialphase I trial a patient with multiply refractory BL had a partial remission on CPI 613 sustained for over one year prior to surgical resection.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03793140

NCT03793140 | A Study of CPI-613 for Patients With ... The purpose of this study is to test any good and bad effects of the study drug, CPI-613. Official Title. A Phase II Clinical Trial of CPI-613 in Patients With ...

4. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_2/CT224/761586/Abstract-CT224-Phase-II-open-label-multi-cohort

Phase II open-label multi-cohort study evaluating CPI-613 ... Best response stable disease in 3(30%) and 2(20%); median PFS 2.3 and 1.7 months; median OS 5.5 and 3.1 months, in cohort 1 and 2 respectively.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5061374/

A Phase II Clinical Trial of CPI-613 in Patients with Relapsed ... In the preliminary assessment of efficacy, the addition of CPI-613 led to a higher response rate (53.9% as compared to 31.6% reported with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5635818/

A phase 1 study of first-in-class agent CPI-613 in combination ... This study hypothesized that the combination of CPI-613 and mFOLFIRINOX in patients with metastatic pancreatic cancer will be safe and ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05325281

Study Details | NCT05325281 | CPI-613 (Devimistat) in ... This is a single-center, open-label, phase I study designed to determine the maximum tolerated dose (MTD) and safety profile of CPI-613® when used concomitantly ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1470204517303145

Safety and tolerability of the first-in-class agent CPI-613 ... CPI-613 is a novel anticancer agent that selectively targets the altered form of mitochondrial energy metabolism in tumour cells, causing changes in ...

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.4172

A phase I/II open-label clinical trial of CPI-613 in ... The primary endpoint was median overall survival (mOS), with the study powered to show a mOS improvement from the historical standard of 14 ...

10. asco.org asco.org/abstracts-presentations/ABSTRACT308251

A single-arm, open-label, phase I study of CPI-613 ... Conclusions: The results demonstrate that CPI 613 can be safely administered with gemcitabine and nab-paclitaxel at doses up to 1,500 m/g2. Efficacy data ...