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B-Precursor ALLPhase 2EWALL-BOLDNCT03480438

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

A Phase 2 study testing Blinatumomab in people with B-Precursor ALL, run by Goethe University at 21 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 56 to 74 years
Conditions the study is for
B-Precursor ALL
What is being tested?
Blinatumomab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
21 sitesGermany
Study dates
1 Jun 2018to 10 Jan 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 56 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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)

Who cannot join

  • 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
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  • 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 exclusion criteria to recommended chemotherapy
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Germany21 sites

  • Uniklinik RWTH Aachen

    Aachen

  • Charité - Campus Benjamin Franklin

    Berlin

  • Vivantes Klinikum Neukölln

    Berlin

  • Städtisches Klinikum Braunschweig

    Braunschweig

  • Klinikum Bremen Mitte

    Bremen

  • Evangelisches Krankenhaus Essen-Werden

    Essen

  • University Hospital of Frankfurt (Main)

    Frankfurt am Main, Hesse, 60590

  • Universitätsklinikum Halle

    Halle

  • Uniklinik Hamburg Eppendorf

    Hamburg

  • Evangelisches Krankenhaus Hamm

    Hamm

  • Städtisches Klinikum Karlsruhe

    Karlsruhe

  • Universitätsklinikum Schleswig-Holstein

    Kiel

  • Gemeinschaftsklinikum Mittelrhein

    Koblenz

  • Universitätsklinikum Leipzig

    Leipzig

  • Klinikum Großhadern

    München

  • Klinikum rechts der Isar der TU München

    München

  • Klinikum Oldenburg

    Oldenburg

  • Universitätsklinik Tübingen

    Tübingen

  • Universitätsklinikum Ulm

    Ulm

  • Helios Klinikum Wuppertal

    Wuppertal

  • Uniklinik Würzburg

    Würzburg

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Conditions
B-Precursor ALL
Being tested
Blinatumomab
Medical subject headings
Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BlinatumomabDrug

    Also called blincyto

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

Study groups in NCT03480438
Study groupRoleWhat they receive
BlinatumomabExperimentalPatients 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.
Receives: Drug: Blinatumomab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: after induction therapy (up to 8 weeks)

Secondary outcomes (14)

  1. Overall Survival

    Probability of overall survival at 1 year after start of therapy

    Measured: 1 year after start of therapy

  2. Adverse Events

    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

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

  3. MRD response after induction and consolidation

    Proportion of patients who achieve a MRD response or a complete MRD response after induction consolidation

    Measured: after induction and consolidation (up to 35 weeks)

  4. Time to MRD relapse

    Time to MRD relapse after prior achievement of MRD response or complete MRD response

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

  5. Continuous complete remission

    Probability of continuous complete remission at 1 year

    Measured: 1 year after start of therapy

  6. Relapse free survival

    Probability of relapse free survival at 1 year

    Measured: 1 year after start of therapy

  7. Event-free survival

    Probability of event-free survival at 1 year

    Measured: 1 year after start of therapy

  8. Relapse localisation

    Proportion of different relapse localisation in relation to total number of relapses

    Measured: In case of relapse, continuously until end of maintenance therapy (up to 27 months)

  9. Quality of life

    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/)

    Measured: until end of maintenance therapy (up to 27 months)

  10. Treatment deviation 1

    Rate of treatment interruptions

    Measured: until end of treatment (up to 39 weeks)

  11. Treatment deviation 2

    Duration of treatment interruptions

    Measured: until end of treatment (up to 39 weeks)

  12. Treatment deviation 3

    Dose reductions

    Measured: until end of treatment (up to 39 weeks)

  13. Treatment deviation 4

    Mitigation strategies

    Measured: until end of treatment (up to 39 weeks)

  14. Treatment deviation 5

    Rate of withdrawals

    Measured: until end of treatment (up to 39 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2018
  2. Study start1 Jun 2018
  3. Primary completion10 Jan 2024
  4. Study completion10 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03480438
Sponsor's protocol ID
EWALL-BOLD
Acronym
EWALL-BOLD
Status last verified
Sep 2025
First submitted
12 Mar 2018
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Blinatumomab in people with B-Precursor ALL, run by Goethe University at 21 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hematologic and MRD response after induction therapy (time frame: after induction therapy (up to 8 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03480438.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.

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