| Inclusion Criteria: | 1) Age >/= 18 years.
2) Philadelphia chromosome-negative ALL or lymphoblastic lymphoma in second relapse or have failed two treatment lines of anti-leukemia chemotherapy.
3) Histologically or cytologically proven ALL and >/= 10% bone marrow blasts. If <10% bone marrow blasts, subject must have histologically or cytologically proven ALL and evaluable extramedullary disease. Sponsor approval must be obtained prior to enrolling subjects who have <10% bone marrow blasts with evaluable extramedullary disease.
4) Achieved a complete response to at least one prior anti-leukemia therapy as defined by a leukemia-free interval of >/= 90 days.
5) For patients with a prior history of stem cell transplantation, </= Grade 1 active skin graft-versus-host disease. No active gastrointestinal or liver graft-versus-host disease.
6) ECOG performance status 0-3.
7) Patients must have normal renal and liver function as defined below within 14 days, inclusive, prior to first dose of Marqibo, unless the abnormality is considered attributable to leukemia:total bilirubin </= 2.0 x institutional ULN, unless the patient has a known diagnosis of Gilbert's disease. If a patient has Gilbert's disease, he/she can participate in this study, however must be monitored closely during the study.
8) Continued: AST/SGOT or ALT/SGPT </= 3 x ULN, Serum creatinine </= 2.0 g/dL or calculated estimated creatinine clearance >/= 50 mL/min/1.73 m^2 based on Cockcroft and Gault formula, unless renal dysfunction is considered due to hematologic malignancy.
9) Never received prior Marqibo treatment.
10) Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to enrollment.
11) If female, the patient is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (e.g., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide or abstinence) from the Screening visit through 30 days after the last dose of Marqibo.
12) If male, the patient agrees to use an acceptable barrier method for contraception from the Screening visit through 30 days after the last dose of Marqibo.
13) Before enrollment, the patient is capable of understanding and complying with parameters as outlined in the protocol and able to sign a written informed consent according to ICH/GCP, and national/local regulations. |