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

Recruitment & Eligibility

Status: Terminated

Sex: All

Target Recruitment: 6

Inclusion 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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants To Successfully Complete Therapy Regimen

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate;Disease Control Rate;Duration of Response;Progression Free Survival;Overall Survival

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