Phase I Study of MLN 9708 in Addition to Chemotherapy for the Treatment of Acute Lymphoblastic Leukemia in Older Adults

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 leukopheresis. Longer steroid use for diseases other than leukemia is permitted.
• •Age 51- 75 years
• •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of any study-related procedures not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.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 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
• •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 \[eg, calendar, ovulation, symptothermal, post-ovulation methods\] 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 (eg, calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception.)