CPI-613 for Lymphoma

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

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new medication called CPI-613. It aims to see if this drug can help patients who might benefit from it. The drug works by targeting specific pathways in the body to treat diseases.

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.

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+