A Study of Inotuzumab and Blinatumomab in People With B-cell Acute Lymphoblastic Leukemia

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMemorial Sloan Kettering Cancer Center

About this trial

The purpose of this study is to find out whether combining inotuzumab and blinatumomab is a safe and effective treatment for participants with newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL).

Eligibility criteria

Qualifiers

Age ≥ 18 years of age.

Newly diagnosed CD19+ and CD22+ B-ALL with the following characteristics

Patients ≥55 years old, OR

ECOG performance status of 2 or more

Disqualifiers

Patients with Burkitt's lymphoma, T-ALL, CML in lymphoid blast crisis and mixed phenotype acute leukemia (MPAL).

Patients with newly diagnosed B-ALL who received prior treatments, with the exception of corticosteroid, hydroxyurea, or one dose of vincristine, are ineligible.

Patients with Ph+ B-ALL by FISH or RT PCR.

ECOG performance status >3.

Trial design

Treatments tested in this trial

  • Blinatumomab Injection

Treatment groups

26 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor

Amgen

Collaborator

Pfizer

Collaborator