The researchers are doing this study to find out whether obecabtagene autoleucel (obe-cel) is an effective treatment for people with B-cell acute lymphoblastic leukemia (ALL) that is in complete remission (CR, meaning all signs of cancer are gone) with no measurable residual disease (MRD-negative, meaning there are no detectable cancer cells). Participants in this study will have received past treatment for their B-cell ALL, and their disease will be in MRD-negative CR for the first time (first MRD-negative CR).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
given as infusion
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities)
Commack, New York, United States
RECRUITINGMemorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
RECRUITINGrelapse free survival (RFS) (Cohort A)
The time from CAR T infusion until non-response, relapse, or death of any cause, censored at last follow up. Non-response will be defined as the presence of \> 5% abnormal lymphoblasts in the bone marrow, or the presence of unequivocal CNS or extramedullary disease after obe-cel infusion. Relapse will be defined as the emergence of \> 5% abnormal lymphoblasts in the bone marrow, or the emergence of new unequivocal CNS or extramedullary disease after obe-cel infusion. Patients will be censored for relapse free survival if they undergo allogenic stem cell transplant or receive any other new treatment (except start or change of TKI maintenance) while in remission.
Time frame: 1 year from infusion
Minimal residual disease (MRD)-negative Event Free Survival (EFS) (Cohort A & B)
The time from CAR T infusion until non-response (including MRD), relapse (including MRD), or death of any cause, censored at last follow up. MRD will be measured in the bone marrow as described above and considered positive if \>10-\^4.
Time frame: 1 year from infusion
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