- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01534702
Dose Escalation of Clofarabine in Combination With Cytarabine and Idarubicin as Induction Therapy in High Risk AML (CIARA)
Phase I/II Study on Cytarabine and Idarubicin Combined With Escalating Doses of Clofarabine as Induction Therapy in Patients With Acute Myeloid Leukemia and High Risk for Induction Failure (AMLSG 17-10)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
- Fas 1
Kontakter och platser
Studieorter
-
-
-
Düsseldorf, Tyskland, 40225
- Har inte rekryterat ännu
- Universitatsklinikum Dusseldorf
-
Kontakt:
- Andrea Kuendgen, MD
- E-post: andrea.kuendgen@med.uni-duesseldorf.de
-
Huvudutredare:
- Andrea Kuendgen, MD
-
Essen, Tyskland, 45239
- Rekrytering
- Klinikum Essen-Werden
-
Kontakt:
- Mohammad Wattad, MD
- E-post: m.wattad@kliniken-essen-sued.de
-
Huvudutredare:
- Mohammad Wattad, MD
-
Freiburg, Tyskland, D-79106
- Rekrytering
- Universitätsklinikum Freiburg
-
Kontakt:
- Michael Luebbert, MD
- E-post: luebbert@mm11.ukl.uni-freiburg.de
-
Huvudutredare:
- Michael Luebbert, MD
-
Hamburg, Tyskland, 20246
- Har inte rekryterat ännu
- Universitätsklinikum Hamburg-Eppendorf
-
Kontakt:
- Walter Fiedler, MD
- E-post: fiedler@uke.uni-hamburg.de
-
Huvudutredare:
- Walter Fiedler, MD
-
Hannover, Tyskland, D-30625
- Rekrytering
- Hannover Medical School
-
Kontakt:
- Juergen Krauter, MD
- Telefonnummer: +49-511-532-3720
- E-post: Krauter.Juergen@MH-Hannover.de
-
Huvudutredare:
- Juergen Krauter, MD
-
Muenchen, Tyskland, 81675
- Har inte rekryterat ännu
- Klinikum Rechts der Isar
-
Kontakt:
- Justus Duyster
- E-post: justus.duyster@lrz.tum.de
-
Huvudutredare:
- Justus Duyster, MD
-
Ulm, Tyskland, 89081
- Har inte rekryterat ännu
- Universitätsklinikum Ulm
-
Kontakt:
- Richard Schlenk, MD
- E-post: Richard.Schlenk@uniklinik-ulm.de
-
Huvudutredare:
- Richard Schlenk, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
Patients with newly diagnosed AML according to WHO classification and aged ≥ 18 years eligible for an intensive induction chemotherapy with with the following characteristics:
- absence of a t(15;17), t(8;21), inv(16)/t(16;16) and the respective fusion transcripts PML-RARA, RUNX1-RUNX1T1 and CBFB-MYH11
- absence of an activating FLT3-mutation (FLT3-ITD or TKD-mutation)
- absence of an NPM1 exon12 mutation
- Written informed consent
- No previous cytotoxic chemotherapy for the treatment of AML (exception: oral hydroxyurea for up to 5 days during screening/baseline to control hyperleukocytosis)
Adequate renal and hepatic functions as indicated by the following laboratory values:
- Serum creatinine > upper limit of normal (ULN) or glomerular filtration rate (GFR) > 60 mL/min/1.73 m2, respectively
- Serum bilirubin < 1.5 x ULN
- Aspartate aminotransferase (AST/SGOT)/ alanine aminotransferase (ALT/SGPT) < 2.5 x ULN
- Alkaline phosphatase (ALP) < 2.5 x ULN
- Capable of understanding the investigational nature, potential risks and benefits of the study
- Women of childbearing potential must have a negative serum pregnancy test with a sensitivity of at least 25 MIU/ml within 72 hours prior to start of IMP treatment
Female patients must meet one of the following criteria:
- For female patients > 50 years of age at the day of inclusion: Menopause since at least 1 year
Female patients < 50 years of age at the day of inclusion who meet all of the following criteria:
- menopause since at least 1 year
- serum FSH levels > 40 MIU/mL
- serum estrogen levels < 30 pg/ml or negative estrogen test
- 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral ovariectomy with or without hysterectomy
- Correct use of two reliable contraception methods from the time of screening/baseline and during the study for a minimum of 90 days after the last administration of study medication. This includes every combination of a hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring) or of an intrauterine device (IUD) with a barrier method (diaphragm, cervical cap, Lea contraceptive, femidom or condom) or with a spermicide. In case the patient takes hormone preparations for suppression of menstruation during the period of aplasia, a suitable and effective method of contraception has to be discussed with the investigator and used by the patient
- General sexual abstinence from the time of screening/baseline, during the study until a minimum of 90 days after the last administration of study medication
- Having only female sexual partners
- Monogamous relationship with sterile male partner
Male patients must meet one of the following criteria:
- 6 weeks after surgical sterilization by vasectomy
- Correct use of two reliable contraception methods from the time of screening/baseline and during the study for a minimum of 90 days after the last administration of study medication. This includes every combination of a hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring) or of an IUD with a barrier method (diaphragm, cervical cap, Lea contraceptive, femidom or condom) or with a spermicide.
- General sexual abstinence from the time of screening/baseline, during the study until a minimum of 90 days after the last administration of study medication
- Having only male sexual partners
- Monogamous relationship with sterile female partner
Exclusion Criteria:
- Current concomitant chemotherapy, radiation therapy or immunotherapy not defined in the study protocol
- Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of oral hydroxyurea. The patient must have recovered from all non-hematological acute toxicities from any previous therapy
- Participation in a clinical trial within 30 days before inclusion in this study or concurrent to this study.
- Bleeding disorder independent of AML
- Patients with uncontrolled systemic fungal, bacterial, viral or other infection (defined as persistent disease signs/symptoms without improvement despite appropriate antibiotics or other treatment)
- HIV Infection
- Pregnant or lactating women
- Any significant concurrent disease, illness, psychiatric disorder or history of serious organ dysfunction that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
Diagnosis of another malignancy, unless the patient is disease-free for at least 3 years following the completion of curative intent therapy, with the following exceptions:
- Myelodysplastic syndrome (MDS) in patients with AML after MDS according to the WHO classification
- Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed.
- Known hypersensitivity to any of the investigational medical products
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Behandling
|
Treatment is stratified according to patients age (< 60 years vs. ≥ 60 years). Medication: Patients < 60 years:
Patients ≥ 60 years:
Clofarabine will be given in escalating doses to cohorts of at least three patients: Clofarabine:
Patients will be recruited according to a 3+3 design. New cohorts will be initiated depending on toxicity of the previous cohort during the first induction cycle. Enrollment will begin with dose level 1. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
maximal tolerated dose of clofarabine in combination with cytarabine and idarubicin
Tidsram: six weeks
|
maximal tolerated dose of clofarabine in combination with cytarabine and idarubicin in the therapy of previously untreated AML and high risk for induction failure
|
six weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
complete remission rate
Tidsram: 12 weeks
|
complete remission rate after two cycles of induction therapy
|
12 weeks
|
relapse-free, event-free and overall survival
Tidsram: 4 years
|
4 years
|
|
blast reduction in the bone marrow after the first induction cycle
Tidsram: 15 days
|
15 days
|
|
duration of aplasia
Tidsram: 12 weeks
|
12 weeks
|
|
therapy-associated morbidity and mortality
Tidsram: 12 weeks
|
12 weeks
|
|
course of molecular and cytogenetic markers during chemotherapy
Tidsram: four years
|
molecular and cytogenetic markers will be evaluated by cytognetic analysis and molecular techniuques (e.g.
RT-PCR)
|
four years
|
fraction of patients who receive an allogeneic stem cell transplantation in first complete remission
Tidsram: four years
|
four years
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Juergen Krauter, MD, Hannover Medical School
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Leukemi
- Leukemi, myeloid
- Leukemi, Myeloid, Akut
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Enzyminhibitorer
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Topoisomeras II-hämmare
- Topoisomerasinhibitorer
- Antibiotika, antineoplastiska
- Clofarabin
- Cytarabin
- Idarubicin
Andra studie-ID-nummer
- KS-2009-003
- 2010-021719-18 (EudraCT-nummer)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Akut myeloid leukemi
-
Betta Pharmaceuticals Co., Ltd.Har inte rekryterat ännuAkut Myeloid Leukemi LeukemiKina
-
Oryzon Genomics S.A.RekryteringAkut myeloid leukemi, i återfall | Akut myeloid leukemi refraktärFörenta staterna
-
University Hospital, AntwerpRekryteringAkut myeloid leukemi, i återfall | Akut myeloid leukemi refraktärBelgien
-
Medical College of WisconsinRekryteringAkut myeloid leukemi, i återfall | Akut myeloid leukemi refraktärFörenta staterna
-
Peking University People's HospitalBeijing JD Biotech Co. LTD.RekryteringAkut myeloid leukemi, i återfall | Akut myeloid leukemi refraktärKina
-
Xuzhou Medical UniversityRekryteringAkut myeloid leukemi, i återfall | Akut myeloid leukemi refraktärKina
-
Bio-Path Holdings, Inc.RekryteringAkut myeloid leukemi, i återfall | Akut myeloid leukemi refraktärFörenta staterna
-
Washington University School of MedicineIndragenRefraktär Akut Myeloid Leukemi | Återfall av akut myeloid leukemiFörenta staterna
-
C. Babis AndreadisGateway for Cancer Research; AVEO Pharmaceuticals, Inc.AvslutadAkut myeloid leukemi | Refraktär Akut Myeloid Leukemi | Återfall av akut myeloid leukemiFörenta staterna
-
Xuzhou Medical UniversityRekryteringAkut myeloid leukemi, i återfall | Akut myeloid leukemi refraktärKina
Kliniska prövningar på clofarabine, cytarabine, idarubicin
-
European Organisation for Research and Treatment...Gruppo Italiano Malattie EMatologiche dell'AdultoOkändMyelodysplastiska syndrom | LeukemiBelgien, Kroatien, Frankrike, Italien, Nederländerna
-
Baylor Research InstituteAvslutadMyelodysplastiska syndrom | Akut myelogen leukemi | Kronisk myelogen leukemiFörenta staterna
-
M.D. Anderson Cancer CenterGenzyme, a Sanofi CompanyAvslutadAkut myeloid leukemi | Kronisk myeloid leukemi | Myelodysplastiskt syndromFörenta staterna
-
French Innovative Leukemia OrganisationRekrytering
-
Sunshine Lake Pharma Co., Ltd.Rekrytering
-
Cooperative Study Group A for HematologyOkändAkut myelogen leukemiKorea, Republiken av
-
Peking Union Medical College HospitalRekrytering
-
European Organisation for Research and Treatment...AvslutadCombination Chemotherapy in Treating Children With Relapsed or Refractory Acute Lymphocytic LeukemiaLeukemiFrankrike, Belgien, Portugal
-
Seoul National University HospitalAvslutadAkut myeloid leukemiKorea, Republiken av
-
Centre Hospitalier Universitaire de NiceJazz Pharmaceuticals; Acute Leukemia French AssociationRekrytering