OncRef

Clinical Trial: NCT02101853

Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-10-21

Study Overview

Brief Summary

This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Immunotherapy with blinatumomab may allow the body's immune system to attack and destroy some types of leukemia cells. It is not yet known whether blinatumomab is more effective than standard combination chemotherapy in treating relapsed B-cell acute lymphoblastic leukemia.

Official Title

Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)

Conditions

Recurrent B Acute Lymphoblastic Leukemia

Intervention / Treatment

  • Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
  • Drug: Asparaginase
  • Biological: Blinatumomab
  • Drug: Cyclophosphamide
  • Drug: Cytarabine
  • Drug: Dexamethasone
  • Drug: Etoposide
  • Drug: Leucovorin Calcium
  • Drug: Mercaptopurine
  • Drug: Methotrexate
  • Drug: Mitoxantrone
  • Drug: Mitoxantrone Hydrochloride
  • Drug: Pegaspargase
  • Other: Pharmacological Study
  • Radiation: Radiation Therapy
  • Drug: Therapeutic Hydrocortisone
  • Drug: Thioguanine
  • Drug: Vincristine
  • Drug: Vincristine Sulfate

Other Study ID Numbers

  • NCI-2014-00631
  • NCI-2014-00631
  • s15-00970
  • COG-AALL1331
  • AALL1331
  • AALL1331
  • U10CA098543
  • U10CA180886

Start Date (Actual)

2014-12-17

Primary Completion Date (Actual)

2021-06-30

Study Completion Date (Estimated)

2027-09-16

Enrollment (Actual)

669

Study Type

Interventional

Phase

Phase 3