To find out if giving blinatumomab as injections under the skin can help to control MRD and keep the disease from coming back in participants with B-cell ALL.
Participants of age ≥18 years with documented B-cell ALL with recurrent or persistent MRD (at a sensitivity of 10-6) while in morphological remission (Includes Ph-, Ph+ and Ph-like).
ECOG Performance status of 0, 1, or 2.
Adequate organ function with creatinine less than or equal to 1.6 mg/dl, bilirubin less than or equal to 3.5 mg/dl and ALT and/or AST less than or equal to 5 times institutional upper limit of normal.
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
Pregnant women are excluded from this study because Blinatumomab, a bispecific T-cell engager agent has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with blinatumomb, breastfeeding should be discontinued if the mother is treated with blinatumomab. These potential risks may also apply to other agents used in this study.
Women of child-bearing potential (WOCBP) must have negative urine or serum pregnancy test within 1 week of study therapy initiation. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization.
Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 4 months after the last dose of protocol specified therapy.
Symptomatic CNS leukemia
M.D. Anderson Cancer Center
Lead sponsor
Amgen
Collaborator