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Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab

NCT03982992 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-03-12

No results posted yet for this study

Summary

This phase 2 study is designed to evaluate the safety, tolerability and efficacy of allogeneic donor lymphocyte infusions (DLI) combined with the bispecific T cell engager blinatumomab in B-precursor ALL patients who have mixed chimerism (MC) or are MRD-positive after allogeneic SCT and are refractory to at least one MRD- or MC-targeted therapy (i.e. blinatumomab, DLI, tyrosine kinase inhibitors or other agents).

Conditions

Interventions

DRUG

Blinatumomab in combination with donor lymphocyte infusion

Continuous blinatumomab infusion in combination with allogeneic donor lymphocyte infusion

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Marion Subklewe, MD · Klinikum der Universität München

  • Christian Schmidt, MD · Klinikum der Universität München

  • Sascha Haubner, MD · Klinikum der Universität München

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2021-05-31
Completion
2021-11-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03982992 on ClinicalTrials.gov