Treatment of Older Patients With B-precursor ALL With Sequential Dose Reduced Chemotherapy and Blinatumomab (EWALL-BOLD)

September 30, 2025 updated by: Nicola Goekbuget, Goethe University

Phase II Trial for the Treatment of Older Patients With Newly Diagnosed CD19 Positive, Ph/BCR-ABL Negative B-precursor Acute Lymphoblastic Leukemia With Sequential Dose Reduced Chemotherapy and Blinatumomab (EWALL-BOLD)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Blinatumomab 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 CD19 expressing cells. In Phase II-III clinical trials 43-69 % of the patients treated with blinatumomab in relapsed/refractory ALL with poor prognostic features, achieved a complete hematologic remission and around 80 % of these obtained a molecular remission as well. Blinatumomab thus has demonstrated significant antileukemic activity in relapsed/refractory adult ALL. The ultimate goal for optimised management of adult ALL is to integrate targeted compounds with known single-drug activity into first-line treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany
        • Uniklinik RWTH Aachen
      • Berlin, Germany
        • Charite - Campus Benjamin Franklin
      • Berlin, Germany
        • Vivantes Klinikum Neukölln
      • Braunschweig, Germany
        • Städtisches Klinikum Braunschweig
      • Bremen, Germany
        • Klinikum Bremen Mitte
      • Essen, Germany
        • Evangelisches Krankenhaus Essen-Werden
      • Halle, Germany
        • Universitatsklinikum Halle
      • Hamburg, Germany
        • Uniklinik Hamburg Eppendorf
      • Hamm, Germany
        • Evangelisches Krankenhaus Hamm
      • Karlsruhe, Germany
        • Stadtisches Klinikum Karlsruhe
      • Kiel, Germany
        • Universitätsklinikum Schleswig-Holstein
      • Koblenz, Germany
        • Gemeinschaftsklinikum Mittelrhein
      • Leipzig, Germany
        • Universitätsklinikum Leipzig
      • München, Germany
        • Klinikum Großhadern
      • München, Germany
        • Klinikum rechts der Isar der TU München
      • Oldenburg, Germany
        • Klinikum Oldenburg
      • Tübingen, Germany
        • Universitätsklinik Tübingen
      • Ulm, Germany
        • Universitatsklinikum Ulm
      • Wuppertal, Germany
        • Helios Klinikum Wuppertal
      • Würzburg, Germany
        • Uniklinik Würzburg
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • University Hospital of Frankfurt (Main)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

56 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with newly diagnosed CD19 positive B-precursor ALL
  2. Greater than 25 % blasts in bone marrow
  3. Eastern Cooperative Oncology Group (ECOG) performance status <= 2
  4. Charlson comorbidity score <= 2
  5. Age > 55 and < 75 years at the time of informed consent

  6. 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)
  7. Negative pregnancy test in women of childbearing potential
  8. Ability to understand and willingness to sign a written informed consent
  9. For Germany: Participation in the registry of the German Multicenter Study Group for Adult ALL (GMALL)

Exclusion Criteria:

  1. Antileukemic pretreatment (GMALL prephase with dexamethasone and cyclophosphamide allowed)

  2. 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
  3. 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
  4. 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
  5. Current autoimmune disease or history of autoimmune disease with potential CNS involvement
  6. Known exclusion criteria to recommended chemotherapy
  7. Known positivity of HIV, hepatitis B (HbsAG) or hepatitis C virus (anti-HCV)
  8. Subject received prior anti-CD19 therapy
  9. Live vaccination within 2 weeks before the start of study treatment

  10. 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

  11. Currently receiving treatment in another investigational device or drug study or less than 30 days since ending treatment on another investigational device or drug study(s). Thirty days is calculated from day 1 of protocol-specified therapy
  12. Subject likely to not be available to complete all protocol-required study visits or procedures, including follow-up visits, and/or to comply with all required study procedures to the best of the subject's and investigator's knowledge
  13. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to subject safety of interfere with the study evaluation, procedures or completion
  14. Woman of childbearing potential and is not willing to use a highly effective method of contraception while receiving study treatment and for an additional 3 months after the last dose of study treatment
  15. Male who has a female partner of childbearing potential, and is not willing to use 2 highly effective forms of contraception while receiving protocol-specified therapy and for at least an additional 3 months after the last dose of protocol-specified therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Blinatumomab

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
Patients will receive standard of care chemotherapy before blinatumomab, between blinatumomab cycles and after blinatumomab.
Other Names:
  • blincyto

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hematologic and MRD response after induction therapy
Time Frame: after induction therapy (up to 8 weeks)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 1 year after start of therapy
Probability of overall survival at 1 year after start of therapy
1 year after start of therapy
Adverse Events
Time Frame: continuously until end-of-core-study (week 43)
Rate and grade of adverse events (AE) according to CTC-AE in induction phase I, blinatumomab induction and during blinatumomab cycle I, II and III
continuously until end-of-core-study (week 43)
MRD response after induction and consolidation
Time Frame: after induction and consolidation (up to 35 weeks)
Proportion of patients who achieve a MRD response or a complete MRD response after induction consolidation
after induction and consolidation (up to 35 weeks)
Time to MRD relapse
Time Frame: continuously until end of maintenance therapy (up to 27 months)
Time to MRD relapse after prior achievement of MRD response or complete MRD response
continuously until end of maintenance therapy (up to 27 months)
Continuous complete remission
Time Frame: 1 year after start of therapy
Probability of continuous complete remission at 1 year
1 year after start of therapy
Relapse free survival
Time Frame: 1 year after start of therapy
Probability of relapse free survival at 1 year
1 year after start of therapy
Event-free survival
Time Frame: 1 year after start of therapy
Probability of event-free survival at 1 year
1 year after start of therapy
Relapse localisation
Time Frame: In case of relapse, continuously until end of maintenance therapy (up to 27 months)
Proportion of different relapse localisation in relation to total number of relapses
In case of relapse, continuously until end of maintenance therapy (up to 27 months)
Treatment deviation 1
Time Frame: until end of treatment (up to 39 weeks)
Rate of treatment interruptions
until end of treatment (up to 39 weeks)
Treatment deviation 2
Time Frame: until end of treatment (up to 39 weeks)
Duration of treatment interruptions
until end of treatment (up to 39 weeks)
Treatment deviation 3
Time Frame: until end of treatment (up to 39 weeks)
Dose reductions
until end of treatment (up to 39 weeks)
Treatment deviation 4
Time Frame: until end of treatment (up to 39 weeks)
Mitigation strategies
until end of treatment (up to 39 weeks)
Treatment deviation 5
Time Frame: until end of treatment (up to 39 weeks)
Rate of withdrawals
until end of treatment (up to 39 weeks)
Quality of life
Time Frame: until end of maintenance therapy (up to 27 months)
Quality of life measures (EORTC=European Organisation for Research and Treatment of Cancer standard scales) at different time-points during induction and consolidation; this is a multidimensional questionnaire with different scales per item such als functional scale, global health status and symptoms. Details are outlined in respective manuals (https://qol.eortc.org/manuals/)
until end of maintenance therapy (up to 27 months)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospitalisation time
Time Frame: until end of treatment (up to 39 weeks)
Number of hospitalisation days
until end of treatment (up to 39 weeks)
Infusion pump systems
Time Frame: until end of treatment (up to 39 weeks)
Use of infusion pump systems
until end of treatment (up to 39 weeks)
Ambulatory care services
Time Frame: until end of treatment (up to 39 weeks)
Use of ambulatory care services
until end of treatment (up to 39 weeks)
Biologic markers
Time Frame: continuously until end of consolidation therapy (up to 35 weeks)
Measurement of biologic markers in bone marrow and peripheral blood throughout induction and consolidation therapy
continuously until end of consolidation therapy (up to 35 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Goethe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nicola Goekbuget, MD, Johann Wolfgang Goethe University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EWALL-BOLD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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