Blinatumomab in Treating Patients With B-cell Acute Lymphoblastic Leukemia With Minimal Residual Disease

NCT02458014 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2014-0844NCI-2015-01547
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well blinatumomab works in treating patients with B-cell acute lymphoblastic leukemia whose disease is in remission (causes no symptoms or signs) but is still present in a small number of cells in the body (minimal residual disease). Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.

Conditions

Adult Acute Lymphoblastic Leukemia in Complete Remission; B Acute Lymphoblastic Leukemia; Minimal Residual Disease; Philadelphia Chromosome Positive

Outcome Measures

Primary Outcomes (1)

• Relapse-free Survival (RFS)

  RFS is relapse-free survival, which is defined as the time interval from date of treatment start until the date of death or hematologic or extramedullary disease relapse. Patients who are alive and relapsefree at the last follow-up date will be censored at that time. In addition, patients who drop off the study due to receiving allogeneic stem cell transplantation will be censored at the time off study.

  From the date of treatment start until the date of death, relapse or discontinuation due to receiving allogeneic stem cell transplantation, assessed up to 112 months.

Secondary Outcomes (3)

• Overall Survival (OS)

  From treatment start to the date of death or last follow-up, whichever occurred first, Up to 10 years, and 1 day

• Number of Patients MRD Negative Overall

  Up to 10 years and 1 day

• Number of Participants Who Were MRD Negative After Course 1

  Up to 6 weeks

Study Arms (2)

Treatment (blinatumomab)

EXPERIMENTAL

Patients receive blinatumomab IV continuously on days 1-28. Treatment repeats every 6 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients who do not proceed with stem cell transplantation may receive blinatumomab IV maintenance therapy with one cycle every 3 months for up to 4 cycles. Patients who remain in MRD remission for 3 months and then become MRD positive again can be retreated following the same treatment plan previously received.

Biological: Blinatumomab

Treatment (blinatumomab + TKI)

EXPERIMENTAL

Patients receive blinatumomab IV continuously on days 1-28. Treatment repeats every 6 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients who do not proceed with stem cell transplantation may receive blinatumomab IV maintenance therapy with one cycle every 3 months for up to 4 cycles. Patients who remain in MRD remission for 3 months and then become MRD positive again can be retreated following the same treatment plan previously received. A TKI will be added at the discretion of the treating physician.

Biological: Blinatumomab; Other: TKI

Interventions

Blinatumomab BIOLOGICAL

Given IV

Also known as: Anti-CD19 x Anti-CD3 Bispecific Monoclonal Antibody, Anti-CD19/Anti-CD3 Recombinant Bispecific Monoclonal Antibody MT103, Blincyto, MEDI-538, MT-103

Treatment (blinatumomab + TKI); Treatment (blinatumomab)

TKI OTHER

A TKI will be added at the discretion of the treating physician.

Treatment (blinatumomab + TKI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with B-lineage acute lymphocytic leukemia (ALL) in hematologic complete remission (CR) with molecular failure (i.e., had never achieved an MRD-negativity status before blinatumomab) or had a molecular relapse (i.e., became MRD positive after having been MRD negative) starting at any time point after 3 months of frontline therapy; molecular disease or minimal residual disease is defined by a value of at least of 1 x 10\^-4 (0.01%) by multicolor flow cytometry and/or by next generation sequencing (NGS)
• Patients with B-lineage ALL in hematologic complete remission (CR) with molecular failure (i.e., had never achieved an MRD-negativity status before blinatumomab) or had a molecular relapse (i.e., became MRD positive after having been MRD negative) starting at any time point after 3 months of frontline therapy; molecular disease or minimal residual disease is defined by a value of at least of 1 x 10-4 (0.01%) by multicolor flow cytometry and/or by next generation sequencing (NGS)
• Performance status of 0, 1, or 2
• Creatinine clearance \>= 30 ml/minute
• Bilirubin less than or equal to 3.0 mg/dL
• No active or co-existing malignancy with life expectancy less than 12 months
• Patients with Philadelphia chromosome positive (Ph+) ALL can be enrolled in CR1 or CR2 and beyond; a tyrosine kinase inhibitor (TKI) will be added at the discretion of the treating physician; MRD for these patients will be defined by PCR of 0.1% and above (International Scale)

You may not qualify if:

• Pregnant or nursing women
• Known to be human immunodeficiency virus positive (HIV+)
• Active and uncontrolled disease/infection as judged by the treating physician
• Unable or unwilling to sign the consent form
• Active central nervous system (CNS) or extramedullary disease
• Monoclonal antibodies therapy within 2 weeks before study entry
• Radiotherapy and cancer chemotherapy (except for intrathecal prophylaxis and/or low-dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, steroids) or any investigational drug within 2 weeks before study entry

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Jabbour EJ, Short NJ, Jain N, Jammal N, Jorgensen J, Wang S, Wang X, Ohanian M, Alvarado Y, Kadia T, Sasaki K, Garris R, Garcia-Manero G, Ravandi F, Kantarjian HM. Blinatumomab is associated with favorable outcomes in patients with B-cell lineage acute lymphoblastic leukemia and positive measurable residual disease at a threshold of 10-4 and higher. Am J Hematol. 2022 Sep;97(9):1135-1141. doi: 10.1002/ajh.26634. Epub 2022 Jun 24.

  PMID: 35713551 DERIVED

• Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.

  PMID: 35622074 DERIVED

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Burkitt Lymphoma; Neoplasm, Residual

Interventions

blinatumomab; N,N-dicyclohexyl-isoborneol-10-sulfonamide

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jabbour,Elias Joseph MD./Professor
• Organization: UT MD Anderson

ejabbour@mdanderson.org

713-792-4764

Study Officials

• Elias Jabbour

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: May 29, 2015
• Study Start: September 14, 2015
• Primary Completion: September 16, 2025
• Study Completion: September 16, 2025
• Last Updated: September 25, 2026
• Results First Posted: September 25, 2026

Record last verified: 2026-09

Locations

US (1)