Christus CEI Obispado

Christus Centro de Excelencia en Investigacion

Recurrence

Residual Neoplasm

Precursor Cell Lymphoblastic Leukemia-Lymphoma

COVID-19

Blinatumomab

Amgen

University of Minnesota (UMN)

condition

allSponsorName

gender

Male

Female

overallStatus

Recruiting

Not yet recruiting

Active, not recruiting

Enrolling by invitation

Completed

Terminated

Withdrawn

Suspended

Unknown

type

Interventional

Observational

Expanded Access

phase

Early Phase 1

Phase 1

Phase 2

Phase 3

Phase 4

Not Applicable

funderTypes

Industry

Other U.S. Federal agency

All others

ageGroup

Child (birth-17)

Adult (18-64)

Older Adult (65+)

The Phase I part of the study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab.

The Phase II part of the study will evaluate the safety, efficacy, and tolerability of SC blinatumomab for treatment of R/R B-ALL and Minimum Residual Disease Positive (MRD+) B-ALL in participants 12 years old and greater. It will also conduct a clinical pharmacokinetic (PK) evaluation of SC1 and SC2 blinatumomab formulations.

A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL

Christus Centro de Excelencia en Investigacion | Christus CEI Obispado

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A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL

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