← Back to Search

Alkylating agents

CPI-613 + Bendamustine for T-Cell Non-Hodgkin Lymphoma and Hodgkin Lymphoma

Phase 1
Waitlist Available
Led By Rakhee Vaidya
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from first dose of 6,8-bis(benzylthio)octanoic acid to death by any cause, assessed up to 3 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment involving two drugs. The first drug, CPI-613, works by shutting off the mitochondria in cancer cells. This deprives the cells of energy and kills them. The second drug, bendamustine hydrochloride, works in different ways to stop the growth of cancer cells. The combination of these two drugs may kill more cancer cells than either drug alone.

Eligible Conditions
  • Hodgkin's Lymphoma
  • T-Cell Lymphoma
  • Hepatosplenic T-cell Lymphoma
  • Peripheral T-Cell Lymphoma
  • Large Granular Lymphocyte Leukemia
  • T-Cell Lymphoblastic Leukemia
  • Non-Hodgkin's Lymphoma
  • Acute Lymphoblastic Leukemia
  • Adult Hodgkin's Lymphoma
  • Adult T-Cell Leukemia/Lymphoma
  • Cutaneous T-Cell Lymphoma
  • Anaplastic Lymphoma
  • Nasal Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from first dose of 6,8-bis(benzylthio)octanoic acid to death by any cause, assessed up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from first dose of 6,8-bis(benzylthio)octanoic acid to death by any cause, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MTD of 6,8-bis(benzylthio)octanoic acid when used in combination with bendamustine hydrochloride, defined as the dose level immediately below the dose level that induced a dose-limiting toxicity in < 2 patients
Other outcome measures
Bone marrow biopsy assessment
DCR, derived from the modified IWG criteria and the International Cutaneous Lymphoma (Olsen criteria) for cutaneous lymphoma
OS
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (CPI-613 and bendamustine hydrochloride)Experimental Treatment2 Interventions
Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-4 of week 1 and on days 1 and 4 of weeks 2 and 3. Patients also receive bendamustine hydrochloride IV over 30 minutes on days 4 and 5 of week 1. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bendamustine hydrochloride
2010
Completed Phase 2
~370
6,8-bis(benzylthio)octanoic acid
2013
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,221 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,473 Total Patients Enrolled
Rakhee VaidyaPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
80 Total Patients Enrolled

Media Library

Bendamustine Hydrochloride (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02168140 — Phase 1
Hodgkin's Lymphoma Research Study Groups: Treatment (CPI-613 and bendamustine hydrochloride)
Hodgkin's Lymphoma Clinical Trial 2023: Bendamustine Hydrochloride Highlights & Side Effects. Trial Name: NCT02168140 — Phase 1
Bendamustine Hydrochloride (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02168140 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been signed up for this experiment?

"At this moment, no more patients are being recruited for this investigation. It was initially posted on September 1st 2014 and the most recent update to its listing occurred on April 8th 2022. For those looking for other studies related to Hodgkin's Disease there are currently 3774 clinical trials enrolling participants while 89 of them involve bendamustine hydrochloride as part of their protocol."

Answered by AI

What prior research has there been into the therapeutic use of bendamustine hydrochloride?

"Initially studied in 2008, bendamustine hydrochloride has since been used in 187 clinical trials. 89 of these are currently active, with a majority based out of Philadelphia, Pennsylvania."

Answered by AI

Are there spaces available for enrollment in this clinical research?

"Through the information hosted on clinicaltrials.gov, it has been determined that this trial is not in need of patients at present; nevertheless, it was initially posted on September 1st 2014 and recently updated on April 8th 2022. Although no longer recruiting participants for this study, there are 3863 other experiments actively enlisting volunteers right now."

Answered by AI

What conditions has bendamustine hydrochloride been proven to effectively alleviate?

"Bendamustine hydrochloride is a medication frequently prescribed to patients with Waldenstrom macroglobulinemia, as well as those struggling with conditions like refractory mantle cell lymphoma, chronic lymphocytic leukemia (CLL), and Hodgkin's Disease."

Answered by AI

What adverse effects might be associated with bendamustine hydrochloride?

"Bendamustine Hydrochloride has only limited evidence backing its safety and efficacy, so it received a score of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
CPI-613 and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma
2014. "CPI-613 and Bendamustine Hydrochloride in Treating Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02168140.
~2 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top