Clinical trial NCT01238146 (phase 1/phase 2, status: withdrawn)
Conditions: extranodal marginal zone b-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone b-cell lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, splenic marginal zone lymphoma
ICD codes: 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
Drugs: bendamustine hydrochloride, obatoclax mesylate
SMILES: CN1C(CCCC(O)=O)=NC2=CC(=CC=C12)N(CCCl)CCCl, COC1=CC(=N\C1=C/C1=C(C)C=C(C)N1)C1=CC2=CC=CC=C2N1
Reason stopped: 
    no patients accrued.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed indolent B-cell non-Hodgkin lymphoma (NHL), including any of
             the following subtypes recognized by WHO classification:

               -  Marginal zone lymphoma

               -  Lymphoplasmacytic lymphoma

               -  Follicular lymphoma

               -  Mantle cell lymphoma

          -  Transformed lymphoma from a low-grade, indolent NHL allowed provided patient has
             received ≥ 1 prior therapy for indolent disease

          -  Must have received ≥ 1 prior therapy

          -  Relapsed disease after autologous or allogeneic stem cell transplantation (SCT)
             allowed (phase I)

               -  No relapse after allogeneic SCT (phase II)

          -  No known CNS lymphoma

          -  ECOG performance status 0-2

          -  ANC ≥ 1,000/µL

          -  Platelet count ≥ 50,000/µL

          -  Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST and ALT ≤ 2.5 times ULN

          -  Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 50 mL/min

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception prior to and for the duration of
             study participation

          -  No active hepatitis B infection

               -  Patients with a history of hepatitis B (surface antigen or core antibody
                  positive) must take lamivudine or equivalent during study therapy

          -  No history of documented human anti-globulin antibodies, or a history of allergic
             reactions attributed to compounds of similar chemical or biologic composition to
             rituximab, bendamustine hydrochloride, or obatoclax mesylate

          -  No uncontrolled intercurrent illness including, but not limited to, any of the
             following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Psychiatric illness and/or social situations that would limit compliance with
                  study requirements

          -  HIV infection allowed provided patient meets the following criteria:

               -  No evidence of co-infection with hepatitis B or C

               -  CD4 cell count ≥ 400/mm³

               -  No evidence of resistant strains of HIV

               -  HIV viral load ≤ 10,000 copies HIV RNA/mL for patients not on anti-HIV
                  combination antiretroviral therapy OR HIV viral load ≤ 50,000 copies HIV RNA/mL
                  for patients on anti-HIV therapy

               -  No history of AIDS-defining conditions

          -  No active secondary malignancy except for non-melanomatous skin cancer

          -  No other concurrent investigational agents

          -  Prior bendamustine hydrochloride allowed provided patient has completed a
             bendamustine-containing regimen within the past 6 months and achieved a partial
             response or better

          -  More than 4 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas
             or mitomycin C) and recovered