- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Lieux d'étude
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Düsseldorf, Allemagne, 40225
- Pas encore de recrutement
- Universitätsklinikum Düsseldorf
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Contact:
- Andrea Kuendgen, MD
- E-mail: andrea.kuendgen@med.uni-duesseldorf.de
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Chercheur principal:
- Andrea Kuendgen, MD
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Essen, Allemagne, 45239
- Recrutement
- Klinikum Essen-Werden
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Contact:
- Mohammad Wattad, MD
- E-mail: m.wattad@kliniken-essen-sued.de
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Chercheur principal:
- Mohammad Wattad, MD
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Freiburg, Allemagne, D-79106
- Recrutement
- Universitatsklinikum Freiburg
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Contact:
- Michael Luebbert, MD
- E-mail: luebbert@mm11.ukl.uni-freiburg.de
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Chercheur principal:
- Michael Luebbert, MD
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Hamburg, Allemagne, 20246
- Pas encore de recrutement
- Universitätsklinikum Hamburg-Eppendorf
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Contact:
- Walter Fiedler, MD
- E-mail: fiedler@uke.uni-hamburg.de
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Chercheur principal:
- Walter Fiedler, MD
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Hannover, Allemagne, D-30625
- Recrutement
- Hannover Medical School
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Contact:
- Juergen Krauter, MD
- Numéro de téléphone: +49-511-532-3720
- E-mail: Krauter.Juergen@MH-Hannover.de
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Chercheur principal:
- Juergen Krauter, MD
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Muenchen, Allemagne, 81675
- Pas encore de recrutement
- Klinikum rechts der Isar
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Contact:
- Justus Duyster
- E-mail: justus.duyster@lrz.tum.de
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Chercheur principal:
- Justus Duyster, MD
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Ulm, Allemagne, 89081
- Pas encore de recrutement
- Universitatsklinikum Ulm
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Contact:
- Richard Schlenk, MD
- E-mail: Richard.Schlenk@uniklinik-ulm.de
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Chercheur principal:
- Richard Schlenk, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Traitement
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
maximal tolerated dose of clofarabine in combination with cytarabine and idarubicin
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
complete remission rate
Délai: 12 weeks
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complete remission rate after two cycles of induction therapy
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12 weeks
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relapse-free, event-free and overall survival
Délai: 4 years
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4 years
|
|
blast reduction in the bone marrow after the first induction cycle
Délai: 15 days
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15 days
|
|
duration of aplasia
Délai: 12 weeks
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12 weeks
|
|
therapy-associated morbidity and mortality
Délai: 12 weeks
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12 weeks
|
|
course of molecular and cytogenetic markers during chemotherapy
Délai: four years
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molecular and cytogenetic markers will be evaluated by cytognetic analysis and molecular techniuques (e.g.
RT-PCR)
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four years
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fraction of patients who receive an allogeneic stem cell transplantation in first complete remission
Délai: four years
|
four years
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Juergen Krauter, MD, Hannover Medical School
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs par type histologique
- Tumeurs
- Leucémie
- Leucémie myéloïde
- Leucémie, myéloïde, aiguë
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Agents antiviraux
- Inhibiteurs d'enzymes
- Antimétabolites, Antinéoplasique
- Antimétabolites
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Inhibiteurs de la topoisomérase II
- Inhibiteurs de la topoisomérase
- Antibiotiques, Antinéoplasiques
- Clofarabine
- Cytarabine
- Idarubicine
Autres numéros d'identification d'étude
- KS-2009-003
- 2010-021719-18 (Numéro EudraCT)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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