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Enzyme Inhibitor
CPI-613 for Lymphoma
Phase 2
Waitlist Available
Led By Ariela Noy, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Failure of at least one previous line of therapy
Must be ≥ 12 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial will test the effects of CPI-613, a new cancer drug, on patients.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the exact side effects are not listed here, participants can expect possible adverse reactions typical for oncology drugs such as nausea, fatigue, blood count changes, liver enzyme alterations which will be closely monitored during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have tried at least one treatment that didn't work for my condition.
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I am 12 years old or older.
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I have recovered from serious side effects of my previous cancer treatments.
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I can care for myself but spend more than half of my waking hours in bed or a chair.
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I am using birth control and have a negative pregnancy test.
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My kidneys are functioning well enough for treatment.
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My diagnosis is a specific type of lymphoma with certain genetic changes.
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I am willing to get a central venous access device if I don't already have one.
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I agree not to breastfeed during the study.
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My previous bone marrow transplant for Burkitt Lymphoma/Leukemia or DHL/THL was unsuccessful, or I am ineligible for or chose not to undergo one.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
overall response rate of CPI-613
Trial Design
1Treatment groups
Experimental Treatment
Group I: CPI-613Experimental Treatment1 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].
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CPI-613
2008
Completed Phase 1
~140
Find a Location
Who is running the clinical trial?
George Washington UniversityOTHER
243 Previous Clinical Trials
453,750 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,598 Total Patients Enrolled
116 Trials studying Leukemia
9,318 Patients Enrolled for Leukemia
City of Hope Medical CenterOTHER
565 Previous Clinical Trials
1,921,436 Total Patients Enrolled
82 Trials studying Leukemia
4,960 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.My kidney function was checked using a specific method because I am under 16.I have tried at least one treatment that didn't work for my condition.I am 12 years old or older.I do not have serious heart or severe lung conditions that could worsen with treatment.I have HIV but it's under control, and I'm not on certain HIV medications that could interfere with the study drug.I haven't had cancer treatment except possibly one area of radiation or a short steroid course in the last 2 weeks.I am under 16 and can do some activities but need help.I have recovered from serious side effects of my previous cancer treatments.I can care for myself but spend more than half of my waking hours in bed or a chair.I am using birth control and have a negative pregnancy test.I am 16-17 years old and mostly take care of myself.My kidneys are functioning well enough for treatment.You have a condition called graft-versus-host disease that is currently active.My diagnosis is a specific type of lymphoma with certain genetic changes.I do not have any ongoing serious bleeding issues.I have brain involvement but am stable and on maintenance therapy if it's in the fluid around my brain.My platelet count is low due to my marrow condition, not other causes.I had a stem cell transplant from a donor within the last 2 months.I am willing to get a central venous access device if I don't already have one.I do not have any uncontrolled medical conditions.I am not on immunosuppressive therapy for graft-versus-host disease.I agree not to breastfeed during the study.My blood clotting time (INR) is less than 1.5 and I'm not on long-term blood thinners.My previous bone marrow transplant for Burkitt Lymphoma/Leukemia or DHL/THL was unsuccessful, or I am ineligible for or chose not to undergo one.
Research Study Groups:
This trial has the following groups:- Group 1: CPI-613
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many Canadian locations are administering this trial?
"Currently, this trial is recruiting out of 10 medical centres. Of these locations, Harrison, Middletown and Uniondale are included in the list. It is advisable to select a clinic that can be reached with minimal effort if you join the study."
Answered by AI
Are there any recorded precedents of CPI-613 research?
"Currently, there are six ongoing studies that focus on the efficacy of CPI-613. None of these trials have reached Phase 3 yet. The majority of research for this medication is conducted in Winston-Salem, North carolina but it can be found at 22 other medical facilities as well."
Answered by AI
How many participants are currently engaging in this clinical experiment?
"In order to complete the trial, 34 qualified individuals are needed. Those interested can seek enrollment at either Memorial Sloan Kettering Westchester in Harrison, New york or Memorial Sloan Kettering Monmouth in Middletown, New jersey."
Answered by AI
Has the Food and Drug Administration given their stamp of approval to CPI-613?
"There is some safety data available on CPI-613, meriting it a score of 2. However, this Phase 2 trial has yet to demonstrate efficacy."
Answered by AI
Are any vacancies available for those wishing to partake in the experiment?
"Affirmative. Data hosted on clinicaltrials.gov verifies that this medical investigation, initially posted on December 31st 2018, is currently searching for participants. Approximately 34 subjects will be recruited from 10 distinct locations."
Answered by AI
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