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

NCT04217317 | Terminated Phase 2 Results FDA Drug

• 3 other identifiers: IRB00062873WFBCCC 28419P30CA012197
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed T-Cell Lymphoma; Refractory T-Cell Lymphoma; Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• Overall Response Rate

  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.

• Disease Control Rate

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

• Duration of Response

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

• Progression Free Survival

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

• Overall Survival

  Maximum observed follow-up of 3 years 9 months

Study Arms (1)

CPI-613 in Combination with Bendamustine

EXPERIMENTAL

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.

Drug: CPI 613; Drug: Bendamustine

Interventions

CPI 613 DRUG

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.

Also known as: devimistat

CPI-613 in Combination with Bendamustine

Bendamustine DRUG

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.

Also known as: Bendeka, Treanda, Bendamustine Hydrochloride

CPI-613 in Combination with Bendamustine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Interventions

devimistat; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Coordinator
• Organization: Wake Forest Baptist Comprehensive Cancer Center

dfunes@wakehealth.edu

336-713-5878

Study Officials

• Rakhee Vaidya, M.B.B.S.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 3, 2020
• Study Start: September 16, 2020
• Primary Completion: April 21, 2023
• Study Completion: July 11, 2024
• Last Updated: May 2, 2025
• Results First Posted: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)