Sponsor:
M.D. Anderson Cancer Center
Code:
NCT01371630
Conditions
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
Burkitt-Like Lymphoma With 11q Aberration
High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
High Grade B-Cell Lymphoma, Not Otherwise Specified
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Interventions
Blinatumomab
Cyclophosphamide
Cytarabine
Dexamethasone
Inotuzumab Ozogamicin
Brief summary:
Conditions
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
Burkitt-Like Lymphoma With 11q Aberration
High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
High Grade B-Cell Lymphoma, Not Otherwise Specified
Study ID
NCT01371630
Start date
Aug 26, 2011
Status verified date
Jul, 2026
Completion date
Dec 25, 2027
Anticipated
Primary completion date
Dec 25, 2027
Anticipated
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Enrollment
276 participants
Anticipated
Allocation
Non randomized
Intervention Model
Parallel Assignment
Primary purpose
Treatment
Arms
experimental: Arm I (inotuzumab ozogamicin, combination chemotherapy)
experimental: Arm II (inotuzumab ozogamicin, combination chemotherapy)
experimental: Arm III (inotuzumab ozogamicin, combination chemotherapy)
Interventions
Blinatumomab
Cyclophosphamide
Cytarabine
Dexamethasone
Inotuzumab Ozogamicin
Laboratory Biomarker Analysis
Mercaptopurine
Methotrexate
Prednisone
Rituximab
Vincristine
Primary outcome measure
Central contacts
Locations
M D Anderson Cancer Center
Recruiting
Houston, Texas, United States, 77030
Contacts
Principal Investigator:
Elias Jabbour
Sponsor
M.D. Anderson Cancer Center
Last update posted
Jul 15, 2026
Last verified
Jul, 2026
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-15.