Treatment of Older Patients With B-precursor ALL With Sequential Dose Reduced Chemotherapy and Blinatumomab

NCT03480438 | Completed Phase 2 DMC

• 1 other identifier: EWALL-BOLD
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 21

Brief Summary

The trial proposed here attempts to reduce induction chemotherapy to phase I of standard induction in patients with B-precursor ALL. Induction phase II will be replaced by blinatumomab. The initial treatment phase is followed by sequential chemotherapy and further blinatumomab cycles.

Conditions

B-Precursor ALL

Outcome Measures

Primary Outcomes (1)

• Hematologic and MRD response after induction therapy

  Proportion of patients achieving a complete hematologic remission and a complete molecular remission (MRD response or complete MRD response) after induction therapy defined as one cycle of chemotherapy and one cycle of blinatumomab

  after induction therapy (up to 8 weeks)

Secondary Outcomes (14)

• Overall Survival

  1 year after start of therapy

• Adverse Events

  continuously until end-of-core-study (week 43)

• MRD response after induction and consolidation

  after induction and consolidation (up to 35 weeks)

• Time to MRD relapse

  continuously until end of maintenance therapy (up to 27 months)

• Continuous complete remission

  1 year after start of therapy

Other Outcomes (4)

• Hospitalisation time

  until end of treatment (up to 39 weeks)

• Infusion pump systems

  until end of treatment (up to 39 weeks)

• Ambulatory care services

  until end of treatment (up to 39 weeks)

Study Arms (1)

Blinatumomab

EXPERIMENTAL

Patients will receive blinatumomab at a dose of 28 μg/day as continuous intravenous infusion at constant flow rate for four weeks defined as one treatment cycle. Up to four cycles will be performed. In case of defined toxicities, the dose of blinatumomab may be reduced to 9 μg/day.

Drug: Blinatumomab

Interventions

Blinatumomab DRUG

Patients will receive standard of care chemotherapy before blinatumomab, between blinatumomab cycles and after blinatumomab.

Also known as: blincyto

Blinatumomab

Eligibility Criteria

• Age: 56 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly diagnosed CD19 positive B-precursor ALL
• Greater than 25 % blasts in bone marrow
• Eastern Cooperative Oncology Group (ECOG) performance status \<= 2
• Charlson comorbidity score \<= 2
• Age \> 55 and \< 75 years at the time of informed consent
• Renal and hepatic function as defined below:
• AST (SGOT), ALT(SGPT) and AP \< 5x upper limit of normal (UNL) (unless related to leukemic liver infiltration by investigator assessment)
• Total bilirubin \< 1.5x ULN (unless related to Gilbert's Meulengracht disease)
• Creatinine \< 1.5x ULN
• Creatinine clearance \>= 50 mL/min (e.g. calculated according Cockroft \& Gault)
• Negative pregnancy test in women of childbearing potential
• Ability to understand and willingness to sign a written informed consent
• For Germany: Participation in the registry of the German Multicenter Study Group for Adult ALL (GMALL)

You may not qualify if:

• Antileukemic pretreatment (GMALL prephase with dexamethasone and cyclophosphamide allowed)
• History of malignancy other than ALL within 5 years prior to start of protocol-specified therapy with the exception of:
• Malignancy treated with curative intent and with no known active disease present for 2 years before enrollment and felt to be at low risk for recurrence by the treating physician including
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• Adequately treated cervical carcinoma in situ without evidence of disease
• Adequately treated breast ductal carcinoma in situ without evidence of disease
• Prostatic intraepithelial neoplasia without evidence of prostate cancer
• History or presence of clinically relevant (per investigator's assessment) CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or psychosis
• Active ALL in the CNS confirmed by CSF analysis) or testes (clinical diagnosis) or other extramedullary involvement; non-bulky lymph node (\< 7.5 cm diameter) involvement will be accepted
• Current autoimmune disease or history of autoimmune disease with potential CNS involvement
• Known positivity of HIV, hepatitis B (HbsAG) or hepatitis C virus (anti-HCV)
• Subject received prior anti-CD19 therapy
• Live vaccination within 2 weeks before the start of study treatment
• Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation:
• Subject has known sensitivity to immunoglobulins or any of the products or components to be administered during dosing

Sponsors & Collaborators

• Goethe University: lead

Study Sites (21)

University Hospital of Frankfurt (Main)

Frankfurt am Main, Hesse, 60590, Germany

Location

Uniklinik RWTH Aachen

Aachen, Germany

Location

Charité - Campus Benjamin Franklin

Berlin, Germany

Location

Vivantes Klinikum Neukölln

Berlin, Germany

Location

Städtisches Klinikum Braunschweig

Braunschweig, Germany

Location

Klinikum Bremen Mitte

Bremen, Germany

Location

Evangelisches Krankenhaus Essen-Werden

Essen, Germany

Location

Universitätsklinikum Halle

Halle, Germany

Location

Uniklinik Hamburg Eppendorf

Hamburg, Germany

Location

Evangelisches Krankenhaus Hamm

Hamm, Germany

Location

Städtisches Klinikum Karlsruhe

Karlsruhe, Germany

Location

Universitätsklinikum Schleswig-Holstein

Kiel, Germany

Location

Gemeinschaftsklinikum Mittelrhein

Koblenz, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Germany

Location

Klinikum Großhadern

München, Germany

Location

Klinikum rechts der Isar der TU München

München, Germany

Location

Klinikum Oldenburg

Oldenburg, Germany

Location

Universitätsklinik Tübingen

Tübingen, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

Helios Klinikum Wuppertal

Wuppertal, Germany

Location

Uniklinik Würzburg

Würzburg, Germany

Location

Related Links

• Trial register of the Kompetenznetz Leukaemie
• Clinical Trials Register Results

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

blinatumomab

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

Study Officials

• Nicola Goekbuget, MD

  Johann Wolfgang Goethe University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 29, 2018
• Study Start: June 1, 2018
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (21)