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Acute Myeloid LeukemiaPhase 2BLASTNCT02502968

BL-8040 Addition to Consolidation Therapy in AML Patients

A Phase 2 study testing Cytarabine and BL-8040 in people with Acute Myeloid Leukemia, run by Dr. Petra Tschanter at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study evaluates the addition of BL-8040 to the standard consolidation therapy with cytarabine in the treatment of acute myeloid leukemia (AML) in adults. Half of participants will receive BL-8040 and cytarabine in combination, while the other half will receive placebo and cytarabine. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Cytarabine and BL-8040
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
194 participants
Where
1 siteGermany
Study dates
Sep 2015to Jul 2018
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or morphologically confirmed diagnosis of AML except for AML M3 (acute promyelocytic leukemia)
  • AML who achieved complete remission (CR), including CRi and CRp after a maximum number of 2 cycles of induction chemotherapy.
  • AML subjects younger than 60 years at the time of diagnosis with intermediate or high-risk cytogenetics
  • ECOG performance status ≤2
  • Laboratory values as follows (at time of randomization): WBC < 30.000/μl and > 1000/μl, Platelets count > 70.000/μl, Creatinine < 1.0 mg/dl. If creatinine is between 1.0mg/dl and 1.3mg/dl, creatinine clearance should be > 30ml/min as calculated using the Cockroft-Gault formula
  • Women of child-bearing potential must practice an acceptable method of birth control until 6 month after the last dose of treatment. Female subjects who are lactating must discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug.
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  • Male with a female partner of childbearing potential using a barrier method of contraception
  • Written informed consent
  • Subject is able and willing to comply with the requirements of the protocol.

Who cannot join

  • Relapsed or refractory AML
  • Start of induction cycle > 90 days before randomization.
  • Subjects who have received >2 cycles of induction chemotherapy for AML therapy.
  • Subjects younger than 60 years at the time of diagnosis with favorable cytogenetics (t(8;21) or inv(16) or t(16;16) or t(15;17)) or the confirmed presence of the resulting fusion protein AML1-ETO, CBFB-MYH11 or PML-RARA.
  • Subjects for which allogeneic HSCT is planned in CR1.
  • Planned further maintenance therapy after the end of the protocol defined consolidation therapy.
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  • Known allergic or hypersensitivity to BL8040- or cytarabine or to any of the test compounds, materials
  • Use of investigational device or agents within 2 weeks or less than 5 half lifes for each investigational product /device at the time of enrolment. Registry studies are permissible.
  • Abnormal liver function tests: Serum AST/ GOT or ALT/ GPT > 3x upper limit of normal (ULN), Serum bilirubin: Total bilirubin > 2.0mg/dl, conjugated bilirubin > 0.8mg/dl
  • O2 saturation < 92% (on room air)
  • Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk
  • Another malignancy within 3 years of enrolment, except in situ malignancy, or low-risk prostate, skin or cervical cancer after curative therapy. History of other cancer that according to the Investigator might confound the assessment of the endpoints of the study.
  • A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications.
  • History of any or more of the following cardiovascular conditions: cardiac angioplasty (within 6 months) or stenting (within 6 months) and/or myocardial infarction (MI) (within 6 months) or cerebro-vascular event within the past 6 months, unstable angina, vascular disease, class III or IV, congestive heart failure (as defined by the New York Heart Association (NYHA))
  • Known central nervous system disease that may jeopardize the subject's study participation according to the investigator judgement
  • Active, uncontrolled infection.
  • Prior clinically significant grade 3-4 non-hematological toxicity to high-dose cytarabine or grade ≥ 2 of neurological toxicity
  • Positive serology for HIV, active Hepatitis C and Hepatitis B (HBsAG pos.) at baseline
  • Left ventricular ejection fraction (LVEF) of <40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO) at baseline
  • Subjects with psychological, psychiatric, neurological, familial, sociological, or geographical conditions that do not permit compliance with the protocol

Trial locations and contacts

1 site in 1 country.

Simone Kowoll, MSc contact

+49-345-5574908

blast@kks-halle.de

Germany1 site, 1 recruiting

  • Univeritätsklinikum Halle, Klinik Innere Medizin 4

    Halle, 06120

    Carsten Müller-Tidow

    Recruiting

Other trials in Germany

About this study

Official title: A Double- Blind, Placebo Controlled, Randomized, Multicenter, Phase II Study to Assess the Efficacy of BL-8040 Addition to Consolidation Therapy in AML Patients

This study evaluates the addition of BL-8040 to the standard consolidation therapy with cytarabine in the treatment of acute myeloid leukemia (AML) in adults. Half of participants will receive BL-8040 and cytarabine in combination, while the other half will receive placebo and cytarabine.

Read the detailed description

The majority of AML patients in first complete Remission (CR) do relapse despite the current consolidation therapy. Leukemic stem cells that are dormant in the bone marrow are presumed to be a major reason for AML relapse. Allogenic stem cell transplantation is an option only for a minority of AML patients in 1st CR. BL-8040 is a novel CXCR4 inhibitor that has a dual mechanism of action: inducing mobilization of leukemic blasts from the bone marrow which enhances cytotoxic effects of chemotherapy and has direct antileukemic, pro-apoptotic properties. The treatment with BL-8040 in combination with consolidation therapy (standard consolidation with high-dose cytarabine) should improve the efficacy of the consolidation therapy resulting in longer lasting remissions.

Being tested
Cytarabine, BL-8040, Placebo (for BL-8040)
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • CytarabineDrug

  • BL-8040Drug

  • Placebo (for BL-8040)Drug

    Powder for solution for injection manufactured to mimic BL-8040

Study groups in NCT02502968
Study groupRoleWhat they receive
Cytarabine & BL8040ExperimentalSubjects ≥60 years: cytarabine 1g/m2 intravenously twice a day over 3 hours on day 1, 3 and 5 on 2 cycles and BL-8040 (1.25 mg/kg) subcutaneously on days 1 to 5 of each cycle Subjects <60 years: cytarabine 3g/m2 intravenously twice a day over 3 hours on day 1, 3 and 5 on 3 cycles and BL-8040 (1.25 mg/kg) subcutaneously on days 1 to 5 of each cycle
Receives: Drug: Cytarabine; Drug: BL-8040
Cytarabine & PlaceboActive comparatorSubjects ≥60 years: cytarabine 1g/m2 intravenously twice a day over 3 hours on day 1, 3 and 5 on 2 cycles and Placebo (for BL-8040) subcutaneously on days 1 to 5 of each cycle Subjects <60 years: cytarabine 3g/m2 intravenously twice a day over 3 hours on day 1, 3 and 5 on 3 cycles and Placebo (for BL-8040) subcutaneously on days 1 to 5 of each cycle
Receives: Drug: Cytarabine; Drug: Placebo (for BL-8040)

What is being measured

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

  1. Relapse Free Survival time

    Relapse is defined as recurrence of leukemic blasts (more than 5%) in the bone marrow after confirmed complete remission

    Measured: 18 months

Secondary outcomes (6)

  1. Overall Survival

    Measured: 18 months

  2. Time to relapse

    Measured: 18 months

  3. Relapse free survival

    Measured: 6, 9, 12 and 18 months

  4. Relapse

    Defined as recurrence of leukemic blasts (more than 5%) in the bone marrow after confirmed complete remission

    Measured: 6, 9, 12 and 18 months

  5. Minimal residual disease

    Immunophenotypic characterization of human bone marrow cells will be done to determine MRD

    Measured: 6, 9, 12 and 18 months

  6. Toxicity

    Number and CTC grade of all adverse events related to study treatment analyzed in an descriptive way

    Measured: enitire study course until 18 months

Timeline

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

  1. First posted20 Jul 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionJul 2018 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
194 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02502968
Sponsor's protocol ID
UKH062014
Acronym
BLAST
Status last verified
Sep 2015
First submitted
6 Jul 2015
Last updated
21 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Ceran E, Jaramillo Segura S, Merbach AK, Rohde C, Wass M, Schaffrath J, Durruthy-Durruthy R, Arribas-Layton M, Sciambi A, Rieger K, Nogai A, Hanel M, Herbst R, Stolzel F, Rollig C, Jost E, Schlenk RF, Lotze M, Noppeney R, Brandts C, Krug U, Gotze KS, Buske S, Florschutz A, Schubert J, Opitz B, Esseling E, von Witzendorff S, Subklewe M, Kaufmann M, Frickhofen N, Scholz CW, Schafer-Eckart K, Kunzmann V, Schmidt-Hieber M, Sayer H, Rank A, Hemmati P, Schuler F, Scheller M, Kowoll S, Steighardt J, Edemir B, Ludwig-Kraus B, Muller LP, Edemir S, Vainstein-Haras A, Sorani E, Glicko-Kabir I, Kadosh S, Tavor S, Gromann C, Wienke A, Bauer M, Wickenhauser C, Baldus CD, Platzbecker U, Cerwenka A, Serve H, Bornhauser M, Junghanss C, Muller-Tidow C. Inhibition of high CXCR4 with motixafortide and absence of single-cell MRD predict outcome after AML consolidation. Blood. 2026 Jul 30;148(5):545-559. doi: 10.1182/blood.2025032033.

    PubMed 41980027

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cytarabine and BL-8040 in people with Acute Myeloid Leukemia, run by Dr. Petra Tschanter at 1 site 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 9 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 21 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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

Contact Simone Kowoll, MSc (+49-345-5574908, blast@kks-halle.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse Free Survival time (time frame: 18 months). 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 NCT02502968, which also lists 1 linked publication.

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 21 Sep 2015.

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