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Protocol No.E1910Principal InvestigatorBaer, Maria
PhasePhase III
Age GroupAdult
TitleA Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults
DescriptionEligible patients will be placed (by chance) into 1 of 2 groups: 1) Blinatumomab with standard of care therapies OR 2) Standard of care therapies alone.

Patients who have no response after induction chemotherapy will be taken off treatment. Patients who acheive some remission will have intensification chemotherapy. After intensification chemotherapy, some patients will take blinatumomab. All subjects will then continue to receive standard of care cancer treatments. Patients in the blinatumomab group may receive up to 2 additional cycles of blinatumomab. All patients will be followed while taking maintenance chemotherapy.
TreatmentBlinatumomab and standard chemotherapy OR Standard Chemotherapy alone
Key Eligibility--35 to 70 years old
--No Mature B ALL is allowed
--Negative for the Philadelphia chromosome
--No other cancers which are under treatment
--No HIV
--Normal heart and organ function
Applicable Disease SitesAcute Lymphoblastic Leukemia
Therapies InvolvedChemotherapy (NOS)
Immunotherapy
Therapy (NOS)
Drugs Involved6-mercaptopurine
Blinatumomab
Cytarabine (Cytosine Arabinoside)
Dexamethasone
Methotrexate
Prednisone
Rituxan (rituximab)
VP-16 (etoposide)
Vincristine
cyclophosphamide
daunorubicin
etoposide
leucovorin
pegaspargase
rituximab
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT02003222
ContactGreenebaum Comprehensive Cancer Center: Nicole Glynn-Cunningham, MS Phone:410-328-7996
Pager:410-328-2337 #3933
Email:nglynn@umm.edu
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