NCT04448834

Blincyto Amgen Acrotech BioPharma PH2 Blincyto Marqibo R/R Philadelphi CD19+ ALL

A Phase 2 Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE® Antibody Blinatumomab (Blincyto) and Vincristine Sulfate Liposomal Injection (Marqibo) in Adult Subjects With Relapsed/Refractory Philadelphia Negative CD19+ Acute Lymphoblastic Leukemia

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dorothy Sipkins, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hypotheses: The Investigator hypothesizes that targeting ALL cells with 2 different modalities, ie liposomal vincristine sulfate as a microtubule inhibitor and blinatumomab as a BITE immuno-oncology therapy, will have at least additive benefits and allow an effective, safe therapeutic option for patients. Further, the Investigator hypothesizes that the combination will result in a high rate of response and thus allow enhanced immunologic recovery. Primary Objectives To evaluate whether the combination will result in a median progression-free survival (PFS) of at least 1 year. To evaluate if the complete remission/complete remission with incomplete hematological recovery (CR/CRi\*) rate is ≧ 75% following 2 cycles in adult subjects with R/R Ph- ALL and duration of remission Secondary Objectives To evaluate the rate of Minimal Residual Disease (MRD) and duration To evaluate the proportion of patients who are able to progress to allogeneic transplantation To evaluate the safety of blinatumomab and liposomal vincristine sulfate in combination To evaluate the effect of the combination and response on measures of immune reconstitution

Conditions

• B-cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Blinatumomab	liposomal vincristine 2.25 mg/m2 weekly x 3 per cycle (weeks 3-5 in cycle 1 and 2-4 in subsequent cycles)

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2020-06-26
• Last updated: 2022-03-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study