NCT03114865

A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance

A Phase IB/II Study of Blinatumomab in Patients With Pre B-cell Acute Lymphoblastic Leukemia (ALL) and B-cell Non-Hodgkin Lymphoma (NHL) as Post-allogeneic Stem Cell Transplant (Allo-HSCT) Remission Maintenance

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators primary objective is to determine the safety and toxicity of incorporating blinatumomab into the post-allogeneic hematopoietic stem cell transplant (HSCT) maintenance setting for patients with CD19+-B-cell malignancies (Acute Lymphoblastic Leukemia \[ALL\], Non-Hodgkin's Lymphoma \[NHL\]).

Conditions

• Acute Lymphoblastic Leukemia
• B-cell Non Hodgkin Lymphoma
• Pre B-Cell Acute Lymphoblastic Leukaemia

Interventions

Type	Name	Description
DRUG	Blinatumomab 9ug	Cycle 1 - Days 1-7: 9 ug/day IV daily
DRUG	Blinatumomab 28 ug	Cycle 1 - Days 8-28: 28 ug/day IV daily
DRUG	Blinatumomab	Cycle 2 - Days 1-28: 28 ug/day IV daily
DRUG	Dexamethasone	Day 1 of Cycle 1 and 2, prior to a step dose (such as cycle 1 day 8), or when restarting an infusion after an interruption of 4 hours or more: 20 mg IV

Timeline

• Start date: 2017-09-05
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2017-04-14
• Last updated: 2025-05-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study