Clinical trial NCT00882206 (phase 2, status: terminated)
Conditions: leukemia, lymphoma
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: cytarabine, decitabine, doxorubicin hydrochloride, imatinib mesylate, methotrexate, pegaspargase, prednisone, vincristine sulfate, vorinostat
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, CN(C)\N=N\C1=C(N=CN1)C(N)=O, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1, CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O, N[C@@H](CC1=CN=CN1)C(O)=O, [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C, CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1, ONC(=O)CCCCCCC(=O)NC1=CC=CC=C1
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of lymphoblastic lymphoma or acute lymphoblastic leukemia with ≥ 5% blasts
             in the bone marrow (M2/M3) (with or without extramedullary disease) that meets 1 of
             the following criteria:

               -  Refractory disease/induction failure (failure to achieve initial remission after
                  2 lines of induction therapy)

               -  Relapsed disease (in first relapse or higher)

          -  Central nervous system (CNS)-positive disease allowed

          -  Karnofsky performance status (PS) 50-100% (for patients ≥ 16 years of age) OR Lansky
             PS 50-100% (for patients < 16 years of age)

          -  Life expectancy ≥ 8 weeks

          -  Creatinine clearance ≥ 70 mL/min OR maximum serum creatinine based on age/gender as
             follows:

               -  0.4 mg/dL (for patients 1 to 5 months of age)

               -  0.5 mg/dL (for patients 6 to 11 months of age)

               -  0.6 mg/dL (for patients 1 year of age)

               -  0.8 mg/dL (for patients 2 to 5 years of age)

               -  1.0 mg/dL (for patients 6 to 9 years of age)

               -  1.2 mg/dL (for patients 10 to 12 years of age)

               -  1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age)

               -  1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients ≥ 16 years of age)

          -  ALT < 5 times upper limit of normal (ULN)

          -  Total bilirubin ≤ 1.5 times ULN for age

          -  LVEF ≥ 40% by ECHO/MUGA scan

          -  Shortening fraction > 29% by ECHO/MUGA scan

          -  Able to swallow capsules

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 2 months after
             completion of study treatment

          -  No untreated positive blood cultures or progressive infections as assessed by
             radiographic studies

          -  No known allergy to any of the agents or their ingredients used in this study

               -  Patients with clinically significant prior allergies to pegaspargase may be
                  treated with asparaginase-Erwinia, if available

          -  Patients who cannot receive asparaginase on this study (e.g., due to prior
             pancreatitis, stroke, or other toxicity) are eligible provided they meet all other
             inclusion/exclusion criteria

          -  Recovered from prior therapy (defined as CTCAE v3.0 toxicity ≤ grade 1)

          -  More than 3 weeks since prior chemotherapy for cancer other than hydroxyurea for
             patients with WBC > 10,000/mm³

          -  At least 7 days since prior hematopoietic growth factors (14 days for pegfilgrastim)

          -  At least 1 month since prior biologic therapy, such as monoclonal antibodies

          -  At least 3 months since prior hematopoietic stem cell transplantation

        Exclusion Criteria:

          -  Evidence of graft-versus-host disease

          -  Concurrent valproic acid

          -  Concurrent coumadin/warfarin other than a short course administered in a prophylactic
             setting