Ixazomib Citrate and Combination Chemotherapy in Treating Older Patients with Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Inclusion Criteria

• Acute lymphoblastic leukemia, excluding known mature B-cell ALL by the presence of any of the following: surface immunoglobulin, L3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8)
• Patients with mature B-cell ALL will be removed from the protocol as soon as that diagnosis is made and should be treated on a B-cell leukemia (Burkitt’s) protocol; NOTE: patients with T-cell surface markers and a t(8;14)(q24;q11) remain eligible
• Patients with lymphoblastic lymphoma are also eligible
• No prior anti-leukemic therapy except the following are allowed: < 1 week of corticosteroids, or hydroxyurea or emergent leukapheresis; longer steroid use for diseases other than leukemia is permitted
• Voluntary written consent must be given before performance of any study-related procedures not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
• If patient is known to be human immunodeficiency virus (HIV) positive, they will not be eligible for the protocol; HIV testing is not mandatory prior to protocol enrollment
• Patients whose comorbid medical condition, in the investigator’s opinion, would make participation in this trial and adherence to the protocol guidelines difficult should be excluded
• Patients with an active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely are excluded
• Ejection fraction >= 45%
• Creatinine < 2.0 times upper limit of normal
• Total bilirubin < 1.5 times upper limit of normal except for known conjugation diseases such as Gilbert’s; direct bilirubin is not an inclusion criteria
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3.0 times upper limit of normal
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
• Non-pregnant and non-lactating * Female patients who: ** Are postmenopausal for at least 1 year before the screening visit, OR ** Are surgically sterile, OR ** If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND ** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR ** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) * Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following: ** Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR ** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR ** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)

Exclusion Criteria

• Female patients who are lactating or have a positive serum pregnancy test during the screening period
• Major surgery within 14 days before enrollment; biopsies and line placement procedures are not exclusion criteria
• Radiotherapy within 14 days before enrollment; radiotherapy is excluded during induction and consolidation 1 while receiving MLN 9708
• Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
• Active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive; hepatitis and HIV testing are not required prior to the start of treatment
• Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol
• Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
• Patient has >= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period
• Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of MLN9708 including difficulty swallowing
• Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease; patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
• Participation in other clinical trials, including those with other investigational agents not included in this trial, within 21days of the start of this trial and throughout induction and consolidation 1 portions of this trial (while on MLN 9708); patients may enroll in transplant and post transplant studies after consolidation 1 treatment
• Systemic treatment, within 14 days before the first dose of MLN9708, with strong inhibitors of cytochrome P450, family 1, subfamily A, polypeptide 2 (CYP1A2) (fluvoxamine, enoxacin), strong inhibitors of cytochrome P450, family 3, subfamily A (CYP3A) (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John’s wort; ciprofloxacin should not be administered for at least 2 days before MLN 9708 administration; extended release ciprofloxacin should not be administered for at least 3 days prior to MLN 9708 administration