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ACTIVE NOT RECRUITING
NCT03114865
PHASE1/PHASE2

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

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

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 \[NHL\]).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2017-09-05

Completion Date

2026-06-30

Last Updated

2025-05-22

Healthy Volunteers

No

Interventions

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

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States