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Alkylating Agent
CPI-613 + Bendamustine for T-Cell Non-Hodgkin's Lymphoma
Phase 2
Recruiting
Led By Rakhee Vaidya, M.B.B.S.
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Patients must have relapsed/refractory disease to one or more systemic therapies.
- Patients must have measurable disease (e.g., a tumor mass >1 cm or evidence of bone marrow involvement).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights
Study Summary
This trial will test the safety of combining CPI-613 with Bendamustine, given every 28 days.
Who is the study for?
This trial is for adults with T-Cell Non-Hodgkin Lymphoma that's come back or didn't respond to treatment. They should have tried at least one therapy, be in good health otherwise, and not have serious heart issues or active infections. Women who can get pregnant and men must use birth control.Check my eligibility
What is being tested?
The study tests CPI-613 combined with Bendamustine given every 28 days to see if it's safe without causing severe side effects. It aims to find out the right dose and how well patients tolerate this combination therapy for lymphoma.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones from drugs like CPI-613 and Bendamustine may include nausea, fatigue, low blood counts leading to infection risk, liver problems, allergic reactions, and potential harm to an unborn baby.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition did not improve after one or more treatments.
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I have a tumor larger than 1 cm or cancer in my bone marrow.
Select...
My condition did not improve after at least one treatment, but I haven't had PUVA.
Select...
My blood, liver, and kidney functions meet the required levels for the trial.
Select...
I do not have any current infections.
Select...
I have CD30-positive lymphoma and cannot take or have already tried brentuximab vedotin.
Select...
My cancer is a type of lymphoma confirmed by lab tests.
Select...
I am able to get out of my bed or chair and move around.
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My condition is Stage IB-IVB mycosis fungoides or Sezary syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants To Successfully Complete Therapy Regimen
Secondary outcome measures
Disease Control Rate
Duration of Response
Overall Response Rate
+2 moreSide effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Hypokalaemia
11%
Dermatitis
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study
Trial Design
1Treatment groups
Experimental Treatment
Group I: CPI-613 in Combination with BendamustineExperimental Treatment2 Interventions
CPI-613 at 2500 mg/m2 is infused intravenously (IV) via a central catheter over 2 hrs on Days 1and 2. Bendamustine at 90 mg/m2 is infused IV over 10 minutes on Days 1 and 2 of each treatment cycle, given immediately after CPI-613 administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bendamustine
2015
Completed Phase 3
~2950
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,225 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,926,061 Total Patients Enrolled
Rakhee Vaidya, M.B.B.S.Principal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It's been over 6 weeks since my last self-donated stem cell transplant or 12 weeks since my donor stem cell transplant.I had cancer before and there's a high chance it could come back.My condition did not improve after one or more treatments.I have a tumor larger than 1 cm or cancer in my bone marrow.I am using birth control and have a negative pregnancy test.I do not have a serious illness that could make treatment dangerous for me.I have been diagnosed with peripheral T-cell lymphoma (PTCL).I haven't taken any cancer treatments or experimental drugs in the last 2 weeks, except for steroids.I had an organ transplant and do not have severe or treatment-requiring graft-versus-host disease.My condition did not improve after at least one treatment, but I haven't had PUVA.My blood, liver, and kidney functions meet the required levels for the trial.It has been over 2 weeks since my last chemotherapy or radiation treatment.I do not have any current infections.I have CD30-positive lymphoma and cannot take or have already tried brentuximab vedotin.You are expected to live for more than 3 months.I am 18 years old or older.I have brain metastases or tumors in my central nervous system.I am not pregnant or using reliable birth control.I haven't had any cancer immunotherapy in the last 2 weeks.My cancer is a type of lymphoma confirmed by lab tests.I am able to get out of my bed or chair and move around.I have HIV, hepatitis B, or C with a detectable viral load.I have had limited treatment with Bendamustine, as decided by my doctor.I can understand and agree to the study's consent form.I am a fertile man and unwilling to use contraception during the study.I do not have active heart disease symptoms like chest pain or heart failure.My condition is Stage IB-IVB mycosis fungoides or Sezary syndrome.
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.
Research Study Groups:
This trial has the following groups:- Group 1: CPI-613 in Combination with Bendamustine
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what sorts of conditions is Bendamustine commonly prescribed?
"Bendamustine, while most commonly used to treat refractory mantle cell lymphoma, has also been found helpful in treating chronic lymphocytic leukemia (cll), hodgkin disease, and multiple myeloma."
Answered by AI
Are there any positions available for participants in this research?
"The trial is currently seeking patients, as indicated by the listing on clinicaltrials.gov. This specific study was first announced on September 16th, 2020 with the most recent update taking place on October 7th, 2022."
Answered by AI
What is the total number of enrollees in this experiment?
"That is accurate. The clinicaltrials.gov website has the study's information, which says that it was originally posted on September 16th 2020 and updated October 7th 2020. The trial is looking for 12 patients from 1 location."
Answered by AI
Does Bendamustine have a high potential for patient harm?
"Bendamustine is a medication that has passed Phase 2 trials, meaning there is evidence suggesting it is safe but not yet effective. Power's team gives it a score of 2."
Answered by AI
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