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

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bendamustine Hydrochloride

Criteria

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 µmol/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.