A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination with CVP (Cyclophosphamide, Vincristine, Prednisone) for Patients with Relapsed/Refractory CD22-Positive Acute Lymphoblastic Leukemia (including B-ALL, Mixed Phenotypic Leukemia and Burkitt's Leukemia)

-Pts must have relapsed/refractory CD22+ acute leukemia (AL) including B-ALL, mixed phenotype leukemia (bilineal and biphenotypic), or Burkitt��s leukemia
- Pts must have >/= 20% of blasts CD22+ (surface)
- Pts must have evidence of AL in peripheral blood or bone marrow
- Pts must have >/= 5% blasts in the blood/marrow within 14 days prior to reg
- Pts must be refractory or have relapsed following prior Induction
- For sites with B1931022 open - pts with precursor B-cell ALL may be eligible providing they are in second salvage or more and B1931022 has been ruled out as a treatment option, or pts were treated on the standard of care arm of B1931022 and failed therapy
- Pts may have prior allo/auto transplant; pts with prior allo must have had transplant >/= 90 days prior to registration and must not have >/= Grade 2 GvHD or either moderate-severe limited chronic GvHD within 14 days prior to reg
Pts with known Ph+ ALL must have either failed treatment or been intolerant to treatment with at least 2 second or third generation TKIs
Pts must not have prior treatment with inotuzumab ozogamicin; prior treatment with other anti-CD22 antibodies must have been completed >/=90 days prior to reg
Pts must have Zubrod PS 0-2
Pts must not have received any chemotherapy, investigational agents, or undergone major surgery within 14 days prior to reg (except: monoclonal antibodies must not have been received for 42 days prior to reg; steroids, vincristine, 6-mercaptopurine, methotrexate, thioguanine and
IT chemo are permitted within 14 days of reg). All drug-related toxicities must have resolved to </= Grade 2
- Pts must not have a uncontrolled systemic bacterial, fungal, or viral infection
Pts must not have any other serious concurrent disease or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that would put the pt at undue risk of undergoing therapy
Pts must not have active CNS involvement. LP required within 14 days prior to reg only if previous documented history of CNS involvement or clinical signs or symptoms consistent with CNS involvement
- Pts must be >/= 18 years of age.
Pts must have peripheral blast count < 25,000/uL within 2 days prior to reg (treatment with hydroxyurea and steroids permitted)
-Pts must have serum creatinine </= 2 x IULN within 7 days prior to reg
-Pts must have bilirubin </= 2 x IULN within 7 days prior to reg (unless primarily unconjugated)
- Pts must have < Grade 2 neuropathy within 7 days prior to reg
- Pts must have SGOT and SGPT </= 2.5 x IULN within 7 days prior to reg
- Pts must not have history of serious allergic or anaphylactic reaction to humanized monoclonal antibodies
- Pts must not have a history of chronic or active Hep B or C infection; must have negative Hep B/C serologies within 28 days prior to reg
- Pts must not have evidence or history of veno-occlusive disease or sinusoidal obstruction syndrome
- Pts must not have a cardiac ejection fraction < 45% (by ECHO or MUGA) or NYHA Stage III or IV heart failure within 14 days prior to reg
- Pts must not have a myocardial infarction within 6 months prior to reg
- Pts must not have a history of clinically significant arrhythmia, prolonged QTc interval, or unexplained syncope not thought to be vasovagal in nature within 6 months prior to reg
- Pts must not have a screening QTcF interval > 500 milliseconds (by Fridericia calculation) based on the average of triplicate EKG performed within 7 days prior to reg
- Pts must not have a history of chronic liver disease (or cirrhosis)
- HIV+ pts are eligible providing: 1) CD4+ cells >/= 350/mm3 (nadir); 2) viral load < 50 copies HIV mRNA/mm3 if on cART or < 25,000 copies HIV mRNA if not on cART; 3) no zidovudine or stavudine as part of cART �C all within 28 days prior to reg
- Pts must not be pregnant or nursing and must have agreed to use an effective contraceptive method
-Prior malignancy other than acute leukemia is allowed, provided it is in remission and there is no plan to treat the malignancy at the time of reg
-Pretreatment cytogenetics must be performed; specimens must be collected within 14 days prior to reg; specimens must be submitted to the site's preferred CLIA-approved cytogenetics lab; reports of the results must be submitted
- Pts or legally authorized rep must be informed of the investigational nature of this study and must sign and give written informed consent