Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease.


Clinical Trial Description

The detection of minimal residual disease (MRD) after induction therapy and/or consolidation therapy is an independent prognostic factor for poor outcome of adult ALL. No standard treatments are available for patients with MRD-positive B-precursor ALL. Blinatumomab (MT103) is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T-cell activation and a cytotoxic T-cell response against cluster of differentiation (CD)19 expressing cells. The purpose of this study is to confirm whether the bispecific T-cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease.

Participants will receive up to four 4-week cycles of intravenous blinatumomab treatment followed by an infusion-free period of 14 days. A safety follow-up will be performed 30 days after the end of the last infusion and efficacy follow-ups will occur until 24 months after treatment start. Participants will be followed for up to 5 years after the start of treatment for survival. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01207388
Study type Interventional
Source Amgen Research (Munich) GmbH
Contact
Status Completed
Phase Phase 2
Start date November 2010
Completion date January 7, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT03671460 - CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL. Phase 1
Recruiting NCT06056752 - QH103 Cell Injection for the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia Phase 1
Recruiting NCT05016947 - Venetoclax Plus Inotuzumab for B-ALL Phase 1
Suspended NCT01974479 - Pilot Study of Redirected Haploidentical Natural Killer Cell Infusions for B-Lineage Acute Lymphoblastic Leukemia Phase 1
Completed NCT00289562 - Forodesine Hydrochloride (BCX-1777) for B-Cell Acute Lymphoblastic Leukemia Phase 1/Phase 2
Recruiting NCT06034275 - Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies Phase 1
Recruiting NCT04191941 - Treatment of Hematological Malignancy With Novel CAR-T Cells. Early Phase 1
Recruiting NCT05333302 - Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma Phase 1
Recruiting NCT04129099 - A Study of GC022F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL Early Phase 1
Recruiting NCT05651191 - To Evaluate the Safety and Efficacy of Human CD19 Targeted DASH CAR-T Cells Injection for Subjects With R/R B-ALL Early Phase 1
Recruiting NCT04150497 - Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01) Phase 1
Withdrawn NCT05571540 - Anti-CD19 Universal CAR-T Cells for r/r CD19+ B-ALL Phase 1/Phase 2
Recruiting NCT03281551 - Efficacy and Safety of PZ01 Treatment in Patients With r/r CD19+ B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma Phase 1
Recruiting NCT05379647 - Natural Killer (NK) Cell Therapy for B-Cell Malignancies Phase 1
Withdrawn NCT04156659 - Study of Tisagenlecleucel in Chinese Pediatric and Young Adult Subjects With Relapsed or Refractory B-cell ALL Phase 2
Recruiting NCT04094311 - Study of Out of Specification for Tisagenlecleucel Phase 3
Active, not recruiting NCT03467256 - CD19 T-CAR for Treatment of Children and Young Adults With r/r B-ALL Phase 1/Phase 2
Terminated NCT04844086 - RPM CD19-mbIL15-CAR-T Cells in Patient With Advanced Lymphoid Malignancies Phase 1
Recruiting NCT05648019 - CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory B-Lineage Leukaemia / Lymphoma - A Feasibility Protocol Phase 2
Not yet recruiting NCT04595162 - A Study of GC019F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL Phase 1