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Relapsed T-Cell LymphomaPhase 2NCT04217317

CPI-613 in Combination With Bendamustine in Patients With Relapsed/Refractory T-Cell Non-Hodgkin Lymphoma

A Phase 2 study testing CPI 613 and Bendamustine in people with Relapsed T-Cell Lymphoma and Refractory T-Cell Lymphoma, run by Wake Forest University Health Sciences at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine if it is possible to give CPI-613 with the drug Bendamustine for 2 days every 28 days without causing severe side effects. In addition, this study will also test the safety of CPI-613 when given in combination with Bendamustine. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CPI 613 and Bendamustine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
16 Sep 2020to 11 Jul 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all of the following inclusion criteria before enrollment:
  • Histologically or cytologically confirmed PTCL (all subtypes) or CTCL (mycosis fungoides/Sezary syndrome) as defined by 2016 World Health Organization (WHO) classification.
  • For patients with PTCL:
  • Patients must have relapsed/refractory disease to one or more systemic therapies.
  • Patients with CD30-positive lymphoma must have received, be ineligible for, or intolerant to brentuximab vedotin.
  • Patients with limited prior exposure to Bendamustine (less than 2 full cycles or ≤ 480 mg/m2) may be included, based on PI discretion.
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  • Patients must have measurable disease (e.g., a tumor mass >1 cm or evidence of bone marrow involvement).
  • For patients with CTCL, Stage IB-IVB mycosis fungoides or Sezary syndrome are eligible
  • Patients must have relapsed/refractory disease to at least one previous systemic therapy. Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy.
  • Male and female patients 18 years of age and older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Expected survival greater than 3 months.
  • Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
  • Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists.
  • At least 2 weeks must have elapsed from prior chemotherapy drugs (other than steroids) or radiation
  • At least 6 weeks must have elapsed from prior autologous stem cell transplant and 12 weeks must have elapsed from prior allogeneic stem cell transplant.
  • Laboratory values ≤2 weeks must be: Adequate hematological function (absolute neutrophil count [ANC] ≥1,500/mm3, platelets ≥100,000/mm3). In subjects with known bone marrow involvement, ANC must be ≥ 1000/mm3 and platelets ≥75,000/mm3; Adequate hepatic function (aspartate aminotransferase [AST/SGOT] less than or equal to 3x upper normal limit [UNL], alanine aminotransferase [ALT/SGPT] less than or equal to 3x UNL (≤5x UNL if liver metastases present), bilirubin less than or equal to 1.5x UNL); Adequate renal function (serum creatinine less than or equal to 1.5 mg/dL or 133 µmol/L).
  • No evidence of current infection.
  • Mentally competent, ability to understand and willingness to sign the informed consent form.

Who cannot join

  • Patients with the following characteristics are excluded:
  • Known cerebral metastases, central nervous system (CNS) or epidural tumor.
  • History of prior malignancy and considered to be at greater than 30% risk of relapse
  • Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication, within the past 2 weeks prior to initiation of treatment with study drugs (steroids are allowed)
  • Patients with a history of allogeneic transplant must not have ≥ grade 3 graft-versus-host disease (GVHD) or any clinically significant GVHD requiring systemic immunosuppression.
  • Serious medical illness that would potentially increase patients' risk for toxicity.
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  • Pregnant women, or women of child-bearing potential not using reliable means of contraception (because the teratogenic potential of CPI-613 is unknown).
  • Lactating females.
  • Fertile men unwilling to practice contraceptive methods during the study period.
  • Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients.
  • Unwilling or unable to follow protocol requirements.
  • Active heart disease including but not limited to symptomatic congestive heart failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic myocardial infarction or symptomatic congestive heart failure.
  • Evidence of current infection..
  • Patients with known HIV infection, hepatitis B, or hepatitis C with positive viral load.
  • Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Pilot Study of CPI-613, in Combination With Bendamustine, in Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma

The purpose of this study is to determine if it is possible to give CPI-613 with the drug Bendamustine for 2 days every 28 days without causing severe side effects. In addition, this study will also test the safety of CPI-613 when given in combination with Bendamustine.

Read the detailed description

Primary Objectives: A pilot Study to evaluate the feasibility, safety and tolerability of a two day course per cycle of Bendamustine plus CPI-613 in patients with relapsed and refractory T cell non-hodgkin lymphoma.

Exploratory Objectives

To evaluate:

  • Overall response rate (ORR) and disease control rate (DCR) derived from the Lugano classification.
  • Duration of response (DOR) derived from the Lugano classification.
  • Progression-Free-Survival (PFS) derived from Lugano classification.
  • Overall Survival (OS).
  • Single cell transcriptomics from PMBCs pre- and post-treatment; for correlative analyses of blood PBMC (and possibly excess pre-treatment tumor biopsy) cell population diversity and functional states to reveal potential mechanisms of drug treatment with regard to patient response status.
Being tested
CPI 613, Bendamustine
Medical subject headings
Lymphoma, T-Cell, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPI 613Drug

    Also called devimistat

    CPI-613 is to be given as 2-hr IV infusion via a central venous catheter. The starting dose of CPI-613 will be 2500 mg/m2 which was determined to be the MTD in the previous phase I clinical trial.

  • BendamustineDrug

    Also called Bendeka, Treanda, Bendamustine Hydrochloride

    Bendamustine at 90 mg/m2 is infused by IV over 10 minutes on Days 1 and 2 of each treatment cycle. Bendamustine is given immediately after CPI-613 administration.

Study groups in NCT04217317
Study groupRoleWhat they receive
CPI-613 in Combination with BendamustineExperimentalCPI-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.
Receives: Drug: CPI 613; Drug: Bendamustine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants To Successfully Complete Therapy Regimen

    Number of patients successfully able to complete 80% (at least 5 of 6 planned cycles) of their therapy regimens.

    Measured: up to 6 cycles, up to 24 weeks after first dose

Secondary outcomes (5)

  1. Overall Response Rate

    Overall response rate is defined as the proportion of patients who achieve a best overall response complete response or partial response during or following study treatment.

    Response derived from the Lugano classification for PTCL patients and Global Response Score for CTCL (MF/SS) patients. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: The Lugano classification.

    Measured: Patients are monitored for best overall response during and after study treatment. Follow-up for response ranged from 2 to 6 months after start of treatment.

  2. Disease Control Rate

    Disease control rate defined as the proportion of patients who achieve a best overall response of complete response, partial response, or stable disease (SD). Best overall response of stable disease must have met the response stable disease criteria at least once ≥12 weeks after start of study treatment. Response derived from the Lugano classification for PTCL patients and Global Response Score for CTCL (MF/SS) patients

    Measured: Patients are monitored for response during and after study treatment. Follow-up for response ranged from 2 to 6 months after start of treatment.

  3. Duration of Response

    Duration of Response will be defined for responders (patients with a best overall response of complete response or partial response). It is the time from the date of the first documented complete response or partial response until the date of the first date of progressive disease, or death due to any cause, whichever occurs first. If a patient has not progressed or died by the analysis cutoff date, duration of response will be censored at the time of the last adequate tumor assessment on or before the cutoff date.

    Response derived from the Lugano classification for PTCL patients and Global Response Score for CTCL (MF/SS) patients.

    Measured: Patients are monitored for response during and after study treatment. Follow-up for response ranged from 2 to 6 months after start of treatment.

  4. Progression Free Survival

    Progression free survival defined as the time from the start of study treatment until the first date of progressive disease, or death due to any cause, whichever occurs first. If a patient has not progressed or died by the analysis cutoff date, progression free survival will be censored at the time of the last adequate tumor assessment on or before the cutoff date.

    Response derived from the Lugano classification for PTCL patients and Global Response Score for CTCL (MF/SS) patients

    Measured: Patients are monitored for progression during and after study treatment. Follow-up for response ranged from 2 to 6 months after start of treatment.

  5. Overall Survival

    Overall survival is measured from the start of study treatment until death due to any cause. If a patient is not known to have died at the date of the analysis cut-off, overall survival will be censored at the last date that: Patient is documented to be alive. At the time of single cell sequencing.

    Measured: Maximum observed follow-up of 3 years 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2020
  2. Study start16 Sep 2020
  3. Primary completion21 Apr 2023
  4. Study completion11 Jul 2024

Why it stopped: Low accruals

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04217317
Sponsor's protocol ID
IRB00062873
Other IDs
WFBCCC 28419, P30CA012197
Status last verified
Apr 2025
First submitted
31 Dec 2019
Last updated
2 May 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CPI 613 and Bendamustine in people with Relapsed T-Cell Lymphoma and Refractory T-Cell Lymphoma, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants To Successfully Complete Therapy Regimen (time frame: up to 6 cycles, up to 24 weeks after first dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04217317.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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