- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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New York
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Buffalo, New York, Stati Uniti, 14263-0001
- Roswell Park Cancer Institute
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
|
Studio correlato
Studio correlato
IV
IV
Correlative study
Correlative Study
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Complete Remission (CR)
Lasso di tempo: 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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Disease-free Survival
Lasso di tempo: 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
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Overall Survival
Lasso di tempo: 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
Lasso di tempo: 4 years
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4 years
|
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Difference in Disease-free and Overall Survival According to p53R2 Protein Sizes
Lasso di tempo: 4 years
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4 years
|
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Difference in Disease-free and Overall Survival According to Multi-drug Resistance Protein Expression
Lasso di tempo: 4 years
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4 years
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Difference in Disease-free and Overall Survival Based on Clofarabine Triphosphate Levels
Lasso di tempo: 4 years
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4 years
|
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A Preliminary Relationship Between Treatment Outcome and Biologic Parameters
Lasso di tempo: 4 years
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4 years
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Meir Wetzler, MD, Roswell Park Cancer Institute
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- leucemia mieloide acuta dell'adulto con anomalie 11q23 (MLL).
- leucemia mieloide acuta dell'adulto con inv(16)(p13;q22)
- leucemia mieloide acuta dell'adulto con t(16;16)(p13;q22)
- leucemia mieloide acuta dell'adulto con t(8;21)(q22;q22)
- leucemia mieloide acuta secondaria
- leucemia mieloide acuta dell'adulto non trattata
- leucemia megacarioblastica acuta dell'adulto (M7)
- leucemia mieloide acuta minimamente differenziata dell'adulto (M0)
- leucemia monoblastica acuta dell'adulto (M5a)
- leucemia monocitica acuta dell'adulto (M5b)
- leucemia mieloblastica acuta dell'adulto con maturazione (M2)
- leucemia mieloblastica acuta dell'adulto senza maturazione (M1)
- leucemia mielomonocitica acuta dell'adulto (M4)
- eritroleucemia dell'adulto (M6a)
- leucemia eritroide pura dell'adulto (M6b)
Termini MeSH pertinenti aggiuntivi
- Neoplasie per tipo istologico
- Neoplasie
- Leucemia
- Leucemia, mieloide
- Leucemia, mieloide, acuta
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Inibitori della topoisomerasi II
- Inibitori della topoisomerasi
- Antibiotici, Antineoplastici
- Clofarabina
- Daunorubicina
Altri numeri di identificazione dello studio
- CDR0000630678
- RPCI-I-132208 (Altro identificatore: Roswell Park Cancer Institute)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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