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

STATUS

Recruiting
End date

Jun 28, 2025
participants needed

12
sponsor

Wake Forest University Health Sciences

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Updated on 19 February 2024

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absolute neutrophil count

renal function

measurable disease

metastasis

neutrophil count

liver metastasis

lymphoma

chemotherapy drugs

hodgkin's disease

systemic therapy

psoralen

ultraviolet light therapy

bendamustine

infertility

renal function test

brentuximab vedotin

liver metastases

peripheral t-cell lymphoma

t-cell lymphoma

metastatic cancer

cutaneous t-cell lymphoma

mycosis fungoides

mycosis fungoides and sezary syndrome

oral contraceptives

non-hodgkin lymphoma

hodgkin lymphoma

mycosis fungoides/sezary syndrome

cutaneous t cell lymphoma

relapsed t-cell lymphoma

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.

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.

Details

Condition	Lymphoma, Lymphoma, Relapsed T-Cell Lymphoma, Refractory T-Cell Lymphoma
Age	18-100 years
Treatment	CPI 613, Bendamustine
Clinical Study Identifier	NCT04217317
Sponsor	Wake Forest University Health Sciences
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
	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 mol/L)
	No evidence of current infection
	Mentally competent, ability to understand and willingness to sign the informed consent form
Exclusion Criteria
	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

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hodgkin lymphoma

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