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Study With Temsirolimus Added to Standard Chemotherapy for Patients Over 60 Years With Acute Myeloblastic Leukemia | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT01611116•Goethe University

View on ClinicalTrials.gov

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. 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.

Eligibility

Age

61 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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
•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
+7 more criteria

Locations (5)

Charité University Hospital Berlin, Campus Benjamin Franklin

Berlin, Germany

University Hospital Dresden

Dresden, Germany

University Hospital Erlangen

Erlangen, Germany

University Hospital Frankfurt

Frankfurt am Main, Germany

University Hospital Münster

Münster, Germany

Key Dates

Start Date

May 1, 2012

Primary Completion Date

April 26, 2017

Completion Date

April 26, 2017

Last Updated

May 24, 2023

Enrollment

ACTUAL participants

Conditions

Acute Myeloblastic Leukemia

Interventions

sodium chloride solution 0.9%

DRUG

temsirolimus

DRUG

Determination of Epigenetic Markers of Acute Myeloblastic Leukemia in Elderly Patients

NCT07250217

Acute Myeloblastic Leukemia

View study

RECRUITINGPHASE4

Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies

NCT07016165

Neutropenic FeverAcute Lymphoblastic Leukemia+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 24, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Determination of Epigenetic Markers of Acute Myeloblastic Leukemia in Elderly Patients

Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies

Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia

Combination Chemotherapy in Treating Young Patients With Down Syndrome and Acute Myeloid Leukemia or Myelodysplastic Syndromes

Yttrium-90 Anti CD66 Monoclonal Antibody in Childhood Relapsed/Refractory Leukaemia

Early Discharge and Outpatients Care in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Previously Treated With Intensive Chemotherapy