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Acute Myeloid LeukemiaPhase 1/2NCT01488344

Phase I/II Trial: BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia (AML)

A Phase 1/2 study testing triple kinase inhibitor BIBF1120 in people with Acute Myeloid Leukemia, run by University Hospital Muenster 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 The sponsor has not verified this record for over two years, so it may be out of date.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

RATIONALE: Low-dose cytarabine works in a minority of elderly patients with an acute myeloid leukemia unfit for intensive induction therapy by killing of leukemia cells. Addition of BIBF1120 to low-dose cytarabine might enhance the killing of leukemia cells. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
triple kinase inhibitor BIBF1120
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteGermany
Study dates
Mar 2012to Nov 2014
Phase
Phase 1/2
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with newly diagnosed AML (except APL) according to the FAB or WHO classification, including AML evolving from MDS or other hematological diseases and AML after previous cytotoxic therapy or radiation (secondary AML), with medical contraindications against or not willing to receive a standard induction and consolidation therapy.
  • Bone marrow aspirate or biopsy must contain > 20% blasts of all nucleated cells. In AML FAB M6 ≥ 30% of non-erythroid cells in the bone marrow must be leukemic blasts. In patients with 20-30% blasts, the indication for a treatment with hypomethylating agents (5-azacitidine or decitabine) should be considered prior to inclusion into the trial.
  • Age ≥ 60 years
  • Informed consent, personally signed and dated to participate in the study
  • Male patients enrolled in this trial must use adequate barrier birth control measures during the course of treatment and for at least 3 months after the last administration of study therapy (low-dose cytarabine and/or BIBF 1120).

Who cannot join

  • Patients with 20-30% bone marrow blasts which are qualifying for and consenting into a therapy with hypomethylating agents
  • Patients who are eligible for and consenting into a standard chemotherapy
  • Known central nervous system manifestation of AML
  • Inadequate liver function (ALT and AST ≥ 2.5 x ULN) if not caused by leukemic infiltration
  • Known chronically active hepatitis C infection or acute hepatitis
  • Chronically impaired renal function (creatinin clearance < 30 ml/min)
Show all 16Show fewer
  • Uncontrolled hypertension with a resting pressure systolic > 160 mmHg or diastolic > 95 mmHg despite adequate treatment
  • severe trauma or surgery within 4 weeks of study entry
  • severe, non-healing wounds, ulcer or fracture
  • Uncontrolled active infection
  • Concurrent malignancies other than AML or other severe diseases which in the opinion of the investigator are likely to influence the endpoint assessment
  • Hypersensitivity to cytarabine (not including drug fever or exanthema)
  • Previous treatment of AML except hydroxyurea up to 24 hours before study medication
  • Previous therapy with tyrosine kinase inhibitors or angiogenesis inhibitors
  • Parallel participation in another clinical trial for the same indication. Eligibility of patients with investigational drug therapy outside of this trial during or within 4 weeks of study entry should be discussed with the study office prior to study entry
  • Any severe concomitant condition, which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitätsklinikum Münster, Medizinische Klinik und Poliklinik A

    Münster, 48149

Other trials in Germany

About this study

Official title: A Single-arm, Open Label, Multi-center Phase I/II Trial to Assess the Safety and Efficacy of BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML Unfit for an Intensive Induction Therapy

RATIONALE: Low-dose cytarabine works in a minority of elderly patients with an acute myeloid leukemia unfit for intensive induction therapy by killing of leukemia cells. Addition of BIBF1120 to low-dose cytarabine might enhance the killing of leukemia cells.

PURPOSE: This phase I / II trial is studying how safe BIBF1120 can be combined with low-dose cytarabine (phase I) and how well the combination of low-dose cytarabine and BIBF1120 works in elderly patients with acute myeloid leukemia unfit for intensive chemotherapy (phase II).

Being tested
triple kinase inhibitor BIBF1120
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.

  • triple kinase inhibitor BIBF1120Drug

    triple kinase inhibitor BIBF1120 is given in addition to low-dose cytarabine

Study groups in NCT01488344
Study groupRoleWhat they receive
BIBF 1120ExperimentalNot described
Receives: Drug: triple kinase inhibitor BIBF1120

What is being measured

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

  1. Phase I: defining maximum tolerated dose (MTD)

    Measured: 4 weeks

  2. Phase II: overall response rate (ORR)

    Measured: up to 6 month

Secondary outcomes (8)

  1. Complete remission (CR) rate

    Measured: up to 12 month

  2. overall survival (OS)

    Measured: up to 12 month

  3. relapse-free survival (RFS)of the responding patients

    Measured: up to 12 month

  4. number of participants with adverse events as a measure of safety and tolerability

    Measured: up to 12 month

  5. ORR rate of the Flt3-mutated patients versus the Flt3-wildtype patients

    Measured: up to 12 month

  6. CR rate of the Flt3-mutated patients versus the Flt3-wildtype patients

    Measured: up to 12 month

  7. OS of the Flt3-mutated patients versus the Flt3-wildtype patients

    Measured: up to 12 month

  8. time to response (CR, CRp, CRi) of the responding patients

    CRp = complete remission with incomplete platelet recovery CRi = complete remission with incomplete neutrophil recovery

    Measured: up to 12 month

Timeline

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

  1. First posted8 Dec 2011 (estimated)
  2. Study startMar 2012
  3. Primary completionNov 2014 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01488344
Sponsor's protocol ID
UKM10_0014
Other IDs
2011-001086-41
Status last verified
Dec 2013
First submitted
15 Nov 2011
Last updated
11 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Berdel AF, Koch R, Gerss J, Hentrich M, Peceny R, Bartscht T, Steffen B, Bischoff M, Spiekermann K, Angenendt L, Mikesch JH, Kewitz T, Butterfass-Bahloul T, Serve H, Lenz G, Berdel WE, Krug U, Schliemann C. A randomized phase 2 trial of nintedanib and low-dose cytarabine in elderly patients with acute myeloid leukemia ineligible for intensive chemotherapy. Ann Hematol. 2023 Jan;102(1):63-72. doi: 10.1007/s00277-022-05025-0. Epub 2022 Nov 18.

    PubMed 36399194

  • Schliemann C, Gerss J, Wiebe S, Mikesch JH, Knoblauch N, Sauer T, Angenendt L, Kewitz T, Urban M, Butterfass-Bahloul T, Edemir S, Vehring K, Muller-Tidow C, Berdel WE, Krug U. A Phase I Dose Escalation Study of the Triple Angiokinase Inhibitor Nintedanib Combined with Low-Dose Cytarabine in Elderly Patients with Acute Myeloid Leukemia. PLoS One. 2016 Oct 7;11(10):e0164499. doi: 10.1371/journal.pone.0164499. eCollection 2016.

    PubMed 27716819

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing triple kinase inhibitor BIBF1120 in people with Acute Myeloid Leukemia, run by University Hospital Muenster 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 5 inclusion and 16 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 11 Dec 2013. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

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?

Phase I: defining maximum tolerated dose (MTD) (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT01488344, which also lists 2 linked publications.

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 11 Dec 2013.

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