Clinical trial NCT02168907 (phase 1, status: terminated)
Conditions: b-cell adult acute lymphoblastic leukemia, b-cell chronic lymphocytic leukemia, cutaneous b-cell non-hodgkin lymphoma, extranodal marginal zone b-cell lymphoma of mucosa-associated lymphoid tissue, intraocular lymphoma, nodal marginal zone b-cell lymphoma, recurrent adult acute lymphoblastic leukemia, recurrent adult burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult grade iii lymphomatoid granulomatosis, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent mycosis fungoides/sezary syndrome, recurrent small lymphocytic lymphoma, refractory chronic lymphocytic leukemia, refractory hairy cell leukemia, small intestine lymphoma, splenic marginal zone lymphoma, testicular lymphoma, waldenström macroglobulinemia
ICD codes: C91.11, C91.12, C91.10, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, C83.57, C83.50, C91.01, C91.02, C83.52, C83.56, C83.53, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, A87.2, K52.832, D72.111, C91.11, C91.12, C91.10, D46.4, D46.1, D46.A, D46.0, D46.20, D46.21, D46.22, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, C88.0
Drugs: 6,8-bis(benzylthio)octanoic acid, bendamustine hydrochloride
SMILES: OC(=O)CCCCC(CCSCC1=CC=CC=C1)SCC1=CC=CC=C1, CN1C(CCCC(O)=O)=NC2=CC(=CC=C12)N(CCCl)CCCl
Reason stopped: 
    slow accruals
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically and cytologically confirmed B-cell NHL that has relapsed from, or is
             refractory to, all standard therapies (including autologous transplantation) known to
             provide clinical benefit, but have not been treated with bendamustine for their
             lymphoma

          -  Must have measurable disease (e.g., a tumor mass > 1 cm)

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Expected survival > 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 any prior surgery

          -  Aspartate aminotransferase (AST/serum glutamic oxaloacetic transaminase [SGOT]) and
             alanine aminotransferase (ALT/serum glutamate pyruvate transaminase [SGPT]) =< 3 x
             upper normal limit (UNL) (=< 5 x UNL if liver metastases present)

          -  Bilirubin =< 1.5 x UNL

          -  Serum creatinine =< 1.5 mg/dL or 133 umol/L

          -  "International normalized ratio" or INR must be =< 1.5

          -  No evidence of active infection and no serious infection within the past month

          -  Mentally competent, ability to understand and willingness to sign the informed consent
             form

        Exclusion Criteria:

          -  Known cerebral metastases, central nervous system (CNS) or epidural tumor

          -  Having "currently active" second malignancy unrelated to Hodgkin lymphoma (HL) or NHL,
             unless they have completed anti-cancer therapy, are in complete response and are
             considered by their physicians to be at less 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

          -  Serious medical illness that would potentially increase patients' risk for toxicity

          -  Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g.,
             active peptic ulcer disease)

          -  History of abdominal fistula or gastrointestinal perforation =< 6 months prior to
             treatment with study drugs

          -  Pregnant women, or women of child-bearing potential not using reliable means of
             contraception

          -  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

          -  Patients with a history of myocardial infarction that is < 3 months prior to
             registration

          -  Evidence of active infection, or serious infection within the past month

          -  Patients with known human immunodeficiency virus (HIV) infection, hepatitis B, or
             hepatitis C

          -  Patients who have received cancer immunotherapy of any type within the past 2 weeks
             prior to initiation of CPI-613 treatment

          -  Requirement for immediate palliative treatment of any kind including surgery