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Acute Myeloblastic LeukemiaPhase 2TOR-AMLNCT01611116

Study With Temsirolimus Added to Standard Chemotherapy for Patients Over 60 Years With Acute Myeloblastic Leukemia

A Phase 2 study testing sodium chloride solution 0.9% and temsirolimus in people with Acute Myeloblastic Leukemia, run by Goethe University at 5 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

Standard chemotherapy is capable of eliminating most leukemic blasts in acute myeloblastic leukemia (AML), while leukemia-initiating cells are not sufficiently eradicated. As a consequence, refractory disease and relapse frequently occur in AML, especially in elderly patients. Read more about this study

Who is it for?
Ages 61 years and older
Conditions the study is for
Acute Myeloblastic Leukemia
What is being tested?
sodium chloride solution 0.9% and temsirolimus
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
5 sitesGermany
Study dates
May 2012to 26 Apr 2017
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 61 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed AML (except APL) according to the FAB classification, including AML evolving from MDS or other hematological diseases and AML after previous cytotoxic therapy or radiation (secondary AML)
  • Bone marrow aspirate or biopsy contains ≥ 20% blasts of all nucleated cells or differential blood count must contain ≥ 20% blasts. In AML FAB M6 ≥ 30% of non-erythroid cells in the bone marrow must be leukemic blasts. In AML defined by cytogenetic aberrations the proportion of blasts may be < 20%.
  • Age ≥ 61 years
  • Informed consent, personally signed and dated to participate in the study
  • Willingness of male patients whose sexual partners are women of child-bearing potential (WOCBP), to use an effective form of contraception (pearl index < 1%) during the study and at least 6 months thereafter.

Who cannot join

  • Patients who are not eligible for standard chemotherapy
  • Previous treatment for AML, except leukapheresis for patients with hyperleukocytosis (leukocytes > 100,000/µl and / or leukostatic syndrome) or hydroxyurea
  • Known central nervous system manifestation of AML
  • Cardiac Disease: Heart failure NYHA III° or IV°; active coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias, defined as: ventricular extrasystoles grade LOWN IV, sustained or non-sustained ventricular tachycardias, and history of ventricular fibrillation / ventricular flutter, unless patient is protected by an internal cardioverter / defibrillator or ventricular arrhythmia was attributable to a myocardial ischemia > 6 months before study entry.
  • Chronically impaired renal function (creatinine clearance < 30 ml / min)
  • Chronic pulmonary disease with relevant hypoxia
Show all 18Show fewer
  • Inadequate liver function (ALT and AST ≥ 2.5 x ULN) if not caused by leukemic infiltration
  • Total bilirubin ≥ 1.2 mg/dL if not caused by leukemic infiltration
  • Uncontrolled active infection
  • Concurrent malignancies other than AML with an estimated life expectancy of less than two years and requiring therapy
  • Known HIV and/or hepatitis C infection
  • Evidence or history of CNS disease, including primary or metastatic brain tumors, seizure disorders
  • History of organ allograft
  • Concomitant treatment with kinase inhibitors, angiogenesis inhibitors, calcineurin inhibitors and Mylotarg
  • Serious, non-healing wound, ulcer or bone fracture
  • Allergy to study medication or excipients in study medication
  • Investigational drug therapy outside of this trial during or within 4 weeks of study entry
  • Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Charité University Hospital Berlin, Campus Benjamin Franklin

    Berlin, 10117

  • University Hospital Dresden

    Dresden, 01307

  • University Hospital Erlangen

    Erlangen, 91054

  • University Hospital Frankfurt

    Frankfurt am Main, 60590

  • University Hospital Münster

    Münster, 48149

Other trials in Germany

About this study

Official title: A Double-blind, Placebo-controlled, Randomized, Multicenter Phase II Trial to Assess the Efficacy of Temsirolimus Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML

Standard chemotherapy is capable of eliminating most leukemic blasts in acute myeloblastic leukemia (AML), while leukemia-initiating cells are not sufficiently eradicated. As a consequence, refractory disease and relapse frequently occur in AML, especially in elderly patients. The investigators propose that the addition of temsirolimus may improve standard AML chemotherapy. Furthermore, temsirolimus may specifically target the leukemia-initiating cells in AML, thereby reducing the risk of leukemia relapse.

The study's main part is preceded by a open label run-in part, in which optimal temsirolimus dose and schedule for the main part o the study will be determined.

Being tested
sodium chloride solution 0.9%, temsirolimus
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.

  • sodium chloride solution 0.9%Drug

    intravenous application added to standard chemotherapy on up to 8 predefined days during the course of study treatment

  • temsirolimusDrug

    Also called Torisel

    intravenous application added to standard chemotherapy on up to 16 predefined days during the course of study treatment

Study groups in NCT01611116
Study groupRoleWhat they receive
sodium chloride solution 0.9%Placebo comparatorNot described
Receives: Drug: sodium chloride solution 0.9%
temsirolimusExperimentalNot described
Receives: Drug: temsirolimus

What is being measured

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

  1. median Event Free Survival (EFS)

    Event Free Survival defined as time interval from day 1 of study treatment until treatment failure, relapse from complete remission (CR) or incomplete remission (CRi), or death from any cause, whichever occurs first.

    Measured: participants will be followed for one year after start of study treatment

  2. event free survival probability

    Event Free Survival defined as time interval from day 1 of study treatment until treatment failure, relapse from complete remission (CR) or incomplete remission (CRi), or death from any cause, whichever occurs first.

    Measured: participants will be followed for one year after start of study treatment

Secondary outcomes (12)

  1. median Event Free Survival (EFS) of AML patients with different cytogenetic and molecular risk groups

    Measured: participants will be followed for one year after start of study treatment

  2. rate of early response after the first induction cycle in the temsirolimus and the control group

    Measured: participants will be followed for one year after start of study treatment

  3. rate of early response of AML patients with different cytogenetic and molecular risk groups

    Measured: participants will be followed for one year after start of study treatment

  4. Complete Remission (CR) rate in the temsirolimus and the control group

    Measured: participants will be followed for one year after start of study treatment

  5. CR rate of AML patients with different cytogenetic and molecular risk groups

    Measured: participants will be followed for one year after start of study treatment

  6. Relapse Free Survival (RFS) of AML patients in the temsirolimus and the control group

    Measured: participants will be followed for one year after start of study treatment

  7. Relapse Free Survival (RFS) of AML patients with different cytogenetic and molecular risk groups

    Measured: participants will be followed for one year after start of study treatment

  8. Overall Survival (OS) of all AML patients in the temsirolimus and the control group

    Measured: participants will be followed for one year after start of study treatment

  9. Overall Survival (OS) of AML patients with different cytogenetic and molecular risk groups

    Measured: participants will be followed for one year after start of study treatment

  10. rate of molecular remissions in the temsirolimus and the control group

    Measured: participants will be followed for one year after start of study treatment

  11. Number of adverse events in the temsirolimus and the control group

    Measured: participants will be followed for one year after start of study treatment

  12. rate of molecular relapse after molecular remission of all AML patients in the temsirolimus and the control group after induction therapy and in the course of the first remission

    Measured: participants will be followed for one year after start of study treatment

Timeline

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

  1. First posted4 Jun 2012 (estimated)
  2. Study startMay 2012
  3. Primary completion26 Apr 2017
  4. Study completion26 Apr 2017

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01611116
Sponsor's protocol ID
3066K1-1165
Acronym
TOR-AML
Status last verified
May 2023
First submitted
25 May 2012
Last updated
24 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Posting of Results in EUDRACT Database: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-002365-37/results

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sodium chloride solution 0.9% and temsirolimus in people with Acute Myeloblastic Leukemia, run by Goethe University at 5 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 5 inclusion and 18 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 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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. Some participants in this study may receive a placebo. 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?

median Event Free Survival (EFS) (time frame: participants will be followed for one year after start of study treatment). 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 NCT01611116, 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 24 May 2023.

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