- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00814164
Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
A Phase II Study Evaluating Mechanisms of Resistance Following Treatment With Clofarabine and Daunorubicin in Newly Diagnosed Adult Acute Myeloid Leukemia Patients > or = to 60 Years Old
RATIONALE: Drugs used in chemotherapy, such as clofarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving clofarabine together with daunorubicin may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving clofarabine together with daunorubicin works in treating older patients with newly diagnosed acute myeloid leukemia.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
OBJECTIVES:
Primary
- Study complete response (CR) and CR without platelet recovery (CRp) following treatment with clofarabine and daunorubicin hydrochloride in older patients with newly diagnosed acute myeloid leukemia.
Secondary
- Study disease-free and overall survival of these patients following treatment with this regimen.
- Compare disease-free and overall survival of patients whose cells do or do not demonstrate apoptosis following treatment with this regimen.
OUTLINE:
- Induction therapy: Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5. Patients are assessed after induction course 1. Patients with ≥ 5% blasts in bone marrow may receive another course of induction therapy beginning between 28-84 days after initiation of course 1. Patients who achieve complete remission (CR) or CR without platelet recovery (CRp) (after 1 or 2 courses of induction therapy) proceed to consolidation therapy.
- Consolidation therapy: Beginning between 28 -84 days after initiation of last course of induction therapy, patients receive clofarabine IV over 1 hour on days 1-3 and daunorubicin hydrochloride IV over 5 minutes on days 1 and 3. Patients may receive a second course of consolidation therapy beginning between 28-84 days of consolidation course 1.
Blood and bone marrow samples are collected periodically to assess response and for pharmacokinetic, cytogenetic, immunophenotyping, and molecular analyses.
After completion of study treatment, patients are followed for at least 2 years.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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New York
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Buffalo, New York, États-Unis, 14263-0001
- Roswell Park Cancer Institute
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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
DISEASE CHARACTERISTICS:
Newly diagnosed acute myeloid leukemia
- At least 10% blasts in the peripheral blood
- De novo or secondary disease
- No acute promyelocytic leukemia with t[15;17] or any other variant
- No clinical evidence of CNS disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- LVEF ≥ 45%
- Estimated glomerular filtration rate ≥ 50 mL/min
- Not pregnant or nursing
- Fertile patients must use effective barrier contraception during and for at least 6 months following study treatment
- No known HIV positivity
- Able to comply with study procedures and follow-up examinations
- No psychiatric disorders that would interfere with consent, study participation, or follow-up
- No uncontrolled systemic fungal, bacterial, viral, or other infection (i.e., exhibiting ongoing signs/symptoms related to the infection and without improvement despite appropriate antibiotics or other treatment)
- No history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo induction therapy with both agents
No other malignancy, unless disease-free for at least 3 years following curative intent therapy
- Nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are allowed if definitive treatment for the condition has been completed
- Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
- No other severe concurrent disease
PRIOR CONCURRENT THERAPY:
- No other concurrent systemic antileukemic therapy (standard or investigational)
- No concurrent cytotoxic therapy or investigational therapy
- No concurrent alternative medications (e.g., herbal or botanical for anticancer purposes)
No prior chemotherapy
- Prior hydroxyurea allowed
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: Clorafarbine with daunorubicin
Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.
|
Étude corrélative
Étude corrélative
IV
IV
Correlative study
Correlative Study
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Complete Remission (CR)
Délai: 2 years
|
Complete Response/Remission (CR) was defined on morphologic criteria at a single response assessment as follows: A bone marrow aspirate or biopsy of < 5% blasts, with evidence of normal hematopoiesis; Absence of Auer rods in the blast that are present; Absence of extramedullary disease [imaging required only if obtained pretreatment for known site(s) of disease]; If applicable and available, absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping; Recovery of peripheral counts (platelets ≥100x109/L, and ANC ≥1.0x109/L).
Peripheral count recovery must be documented no earlier than 7 days prior to, and no later than 14 days following, the bone marrow assessment that provides evidence of the CR.
Complete Response/Remission without platelet recovery (CRp) was defined as all criteria for CR except for thrombocytopenia (platelet count ≥75x109/L).
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2 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Disease-free Survival
Délai: 5 years
|
Disease-free survival was defined as time from first objective documentation of CR or CRp until the date of first objective documentation of disease relapse or death due to any cause, whichever occurs first.
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5 years
|
Overall Survival
Délai: 4 years
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Overall survival was defined as time from date of treatment initiation until date of death due to any cause.
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4 years
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Differences in Disease-free and Overall Survival Between Patients Whose Cells do or do Not Demonstrate Apoptosis Following Clofarabine and Daunorubicin Hydrochloride Therapy
Délai: 4 years
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4 years
|
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Difference in Disease-free and Overall Survival According to p53R2 Protein Sizes
Délai: 4 years
|
4 years
|
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Difference in Disease-free and Overall Survival According to Multi-drug Resistance Protein Expression
Délai: 4 years
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4 years
|
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Difference in Disease-free and Overall Survival Based on Clofarabine Triphosphate Levels
Délai: 4 years
|
4 years
|
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A Preliminary Relationship Between Treatment Outcome and Biologic Parameters
Délai: 4 years
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4 years
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Meir Wetzler, MD, Roswell Park Cancer Institute
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- leucémie myéloïde aiguë de l'adulte avec anomalies 11q23 (MLL)
- leucémie myéloïde aiguë de l'adulte avec inv(16)(p13;q22)
- leucémie myéloïde aiguë de l'adulte avec t(16;16)(p13;q22)
- leucémie myéloïde aiguë de l'adulte avec t(8;21)(q22;q22)
- leucémie myéloïde aiguë secondaire
- leucémie myéloïde aiguë de l'adulte non traitée
- leucémie aiguë mégacaryoblastique de l'adulte (M7)
- leucémie myéloïde aiguë peu différenciée de l'adulte (M0)
- leucémie aiguë monoblastique de l'adulte (M5a)
- leucémie monocytaire aiguë de l'adulte (M5b)
- leucémie aiguë myéloblastique de l'adulte avec maturation (M2)
- leucémie aiguë myéloblastique de l'adulte sans maturation (M1)
- leucémie aiguë myélomonocytaire de l'adulte (M4)
- érythroleucémie adulte (M6a)
- leucémie érythroïde pure de l'adulte (M6b)
Termes MeSH pertinents supplémentaires
- Tumeurs par type histologique
- Tumeurs
- Leucémie
- Leucémie myéloïde
- Leucémie, myéloïde, aiguë
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Antimétabolites, Antinéoplasique
- Antimétabolites
- Agents antinéoplasiques
- Inhibiteurs de la topoisomérase II
- Inhibiteurs de la topoisomérase
- Antibiotiques, Antinéoplasiques
- Clofarabine
- Daunorubicine
Autres numéros d'identification d'étude
- CDR0000630678
- RPCI-I-132208 (Autre identifiant: Roswell Park Cancer Institute)
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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