Phase II Study of Blinatumomab and Concurrent Oral Tyrosine Kinase Inhibitor Therapy as Consolidation and Maintenance Therapy for Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Following Chemotherapy-Sparing Induction

NCT04329325 Phase 2 ACTIVE_NOT_RECRUITING

The purpose of this study is to test whether blinatumomab in combination with TKI therapy (such as dasatinib) is an effective treatment for people with Ph+ ALL. Researchers want to improve the response to standard-of-care treatment of corticosteroids + TKI therapy by adding the study drug, blinatumomab.

Details

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	17
Start date	2020-03-30
Completion	2027-03

Conditions

• Acute Lymphoblastic Leukemia
• Philadelphia Chromosome-Positive

Interventions

• Blinatumomab
• dasatinib
• dexamethasone
• methotrexate

Primary outcomes

• Proportion of evaluable patients achieving complete molecular response — 7 months
  (MRD negativity by flow cytometry and quantitative PCR of BCR-ABL transcripts) at any time during TKI + corticosteroid induction or consolidation with up to 3 cycles of blinatumomab in combination with TKI.

Countries

United States