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

IRB00062873

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.

2020-09-16

2024-11-01

2025-06-01

Recruiting

Early phase I

12

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}

2024-05-14