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Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia

21 aprile 2016 aggiornato da: Teva Branded Pharmaceutical Products R&D, Inc.

An Open-Label Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia

The primary objective of phase 1 of this study is to establish the recommended phase II dose (RP2D). The primary objective of phase 2 of this study is to evaluate the safety and efficacy of bendamustine at the recommended pediatric dose for the treatment of pediatric patients with relapsed or refractory acute leukemia.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

43

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Australia
      • Herston, Australia
        • Teva Investigational Site 300
      • Parkville, Australia
        • Teva Investigational Site 301
      • Randwick, Australia
        • Teva Investigational Site 302
  • Bielorussia
      • Minsk, Bielorussia
        • Teva Investigational Site 520
  • Brasile
      • Barretos-SP, Brasile
        • Teva Investigational Site 615
      • Caxias do Sul, Brasile
        • Teva Investigational Site 616
      • Curitiba-PR, Brasile
        • Teva Investigational Site 613
      • Porto Alegre, Brasile
        • Teva Investigational Site 612
      • Porto Alegre, Brasile
        • Teva Investigational Site 614
      • Sao Paulo, Brasile
        • Teva Investigational Site 610
      • Sao Paulo, Brasile
        • Teva Investigational Site 611
      • Sao Paulo-SP, Brasile
        • Teva Investigational Site 617
  • Canada
      • Toronto, Canada
        • Teva Investigational Site 100
  • Corea, Repubblica di
      • Seoul, Corea, Repubblica di
        • Teva Investigational Site 330
      • Seoul, Corea, Repubblica di
        • Teva Investigational Site 331
      • Seoul, Corea, Repubblica di
        • Teva Investigational Site 332
      • Seoul, Corea, Repubblica di
        • Teva Investigational Site 333
  • Federazione Russa
      • Moscow, Federazione Russa
        • Teva Investigational Site 511
      • St. Petersburg, Federazione Russa
        • Teva Investigational Site 510
  • Israele
      • Jerusalem, Israele
        • Teva Investigational Site 501
      • Petach Tikva, Israele
        • Teva Investigational Site 503
      • Ramat Gan, Israele
        • Teva Investigational Site 502
  • Messico
      • Guadalajara, Messico
        • Teva Investigational Site 603
      • Mexico City, Messico
        • Teva Investigational Site 600
      • Mexico City, Messico
        • Teva Investigational Site 601
      • Monterrey, Messico
        • Teva Investigational Site 602
  • Nuova Zelanda
      • Auckland, Nuova Zelanda
        • Teva Investigational Site 303
  • Polonia
      • Bialystok, Polonia
        • Teva Investigational Site 531
      • Lublin, Polonia
        • Teva Investigational Site 530
      • Warszawa, Polonia
        • Teva Investigational Site 532
  • Singapore
      • Singapore, Singapore
        • Teva Investigational Site 320
  • Stati Uniti
    • California
      • Orange, California, Stati Uniti
        • Teva Investigational Site 17
      • San Diego, California, Stati Uniti
        • Teva Investigational Site 12
    • Florida
      • St. Petersburg, Florida, Stati Uniti
        • Teva Investigational Site 10
    • Maryland
      • Baltimore, Maryland, Stati Uniti
        • Teva Investigational Site 8
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti
        • Teva Investigational Site 16
    • Michigan
      • Detroit, Michigan, Stati Uniti
        • Teva Investigational Site 9
    • Mississippi
      • Jackson, Mississippi, Stati Uniti
        • Teva Investigational Site 1
    • Missouri
      • Kansas City, Missouri, Stati Uniti
        • Teva Investigational Site 5
      • St. Louis, Missouri, Stati Uniti
        • Teva Investigational Site 14
    • New York
      • New York, New York, Stati Uniti
        • Teva Investigational Site 15
    • Oregon
      • Portland, Oregon, Stati Uniti
        • Teva Investigational Site 18
    • Pennsylvania
      • Hershey, Pennsylvania, Stati Uniti
        • Teva Investigational Site 11
      • Philadelphia, Pennsylvania, Stati Uniti
        • Teva Investigational Site 7
    • Tennessee
      • Memphis, Tennessee, Stati Uniti
        • Teva Investigational Site 19
    • Texas
      • Dallas, Texas, Stati Uniti
        • Teva Investigational Site 3
      • Fort Worth, Texas, Stati Uniti
        • Teva Investigational Site 4
      • Houston, Texas, Stati Uniti
        • Teva Investigational Site 13
    • Washington
      • Seattle, Washington, Stati Uniti
        • Teva Investigational Site 2
    • Wisconsin
      • Milwaukee, Wisconsin, Stati Uniti
        • Teva Investigational Site 6

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 1 anno a 20 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Key Inclusion Criteria:

  • The patient has histologically proven acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML) that has relapsed or is refractory to the last regimen, and the patient is without alternative curative therapy.
  • The patient's last myelosuppression therapy ended at least 2 weeks before the first dose of study drug.
  • Nonhematologic acute toxic effects of prior therapy have resolved to grade 2 or less according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
  • The patient has adequate liver function with bilirubin values less than or equal to 1.5 times the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values less than or equal to 5 times the age-appropriate ULN.
  • The patient has adequate renal function with serum creatinine values less than 2 times ULN.
  • The patient has Karnofsky or Lansky performance status of 60 or greater. Patients older than 16 years of age will be scored according to the Karnofsky scale and patients 16 years of age or younger will be scored according to the Lansky scale.
  • The patient may have had hematopoietic stem cell transplantation.
  • Women of childbearing potential (not surgically sterile) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of treatment and for 30 days after the end of treatment.
  • Men not surgically sterile or who are capable of producing offspring must practice abstinence or use a barrier method of birth control, and must agree to continue use of this method for the duration of treatment and for 30 days after the end of treatment.
  • The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.

Key Exclusion Criteria:

  • The patient has any active, uncontrolled systemic infection, severe concurrent disease, or symptomatic untreated central nervous system (CNS) involvement.
  • The patient has evidence of active graft versus host disease.
  • The patient has a known human immunodeficiency virus (HIV) infection.
  • The patient has active hepatitis B or hepatitis C infection.
  • The patient is a pregnant or lactating woman. Any women becoming pregnant during the study will be withdrawn from the study immediately.
  • The patient has any serious uncontrolled medical or psychological disorder that would impair the ability of the patient to receive study drug.
  • The patient has any condition that places the patient at unacceptable risk or confounds the ability of the investigators to interpret study data.
  • The patient has received any other investigational agent within 30 days of study entry.
  • The patient has known hypersensitivity to bendamustine or mannitol.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

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: Bendamustine
Bendamustine 90 or 120 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
Droga: Bendamustine

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recommended Phase II Dose (RP2D) of Bendamustine
Lasso di tempo: Induction Cycle (21- to 35-day cycle)
RP2D was determined by a traditional 3+3 dose escalation design, with the following restrictions: only doses of 60, 90, 120, and 150 mg/m^2 were explored, and escalation to 150 mg/m^2 would only occur if the 120 mg/m^2 dose was deemed safe and pharmacokinetic data indicate subtherapeutic exposure as compared with adults. The first cohort was administered bendamustine at the 90 mg/m^2 dose; de-escalation to the 60 mg/m^2 dose would only occur if the starting dose led to dose-limiting toxicity (DLT) in 2 or more participants. A DLT was defined as any study drug-related nonhematologic adverse event (AE) that was grade 4 for toxicity by National Cancer Institute's Common Toxicity Criteria for AEs, version 4. In addition, grade 3 or above allergic reaction or skin rash were considered DLTs. Hematologic AEs were not considered DLTs. The dose level at which at least 2 of 3 or 2 of 6 participants had a DLT was considered as exceeding the RP2D. The RP2D was the dose 1 step below that level.
Induction Cycle (21- to 35-day cycle)
Overall Response Rate (ORR)
Lasso di tempo: Assessed at each treatment cycle (21 to 35 days), for a maximum of 12 cycles
ORR was calculated as follows: number of participants in the primary analysis set achieving a best overall response of complete remission without platelet recovery (CRp) or complete remission (CR), divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A CR required no evidence of circulating blasts or extramedullary disease, an M1 marrow (≤ 5% bone marrow blasts), and recovery of peripheral counts (platelets ≥ 100 × 10^9/L and absolute neutrophil count ≥ 1.0 × 10^9/L). A CR without platelet recovery (CRp) required all of the criteria for a CR with the exception of platelet recovery.
Assessed at each treatment cycle (21 to 35 days), for a maximum of 12 cycles

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Best Overall Tumor Response Rate
Lasso di tempo: At each treatment cycle (21 to 35 days), for a maximum of 12 cycles
Biological activity of bendamustine was defined as achieving a best response of partial response (PR), CRp, or CR. Rate was calculated as follows: number of participants in the primary analysis set achieving a best overall response of PR, CRp, or CR, divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A PR had to meet the following criteria: complete disappearance of circulating blasts and an M2 marrow (≥ 5% and ≤ 25% bone marrow blasts) and appearance of normal progenitor cells or an M1 marrow that did not qualify for CR or CRp. See Outcome Measure 2 for full definitions for CRp and CR.
At each treatment cycle (21 to 35 days), for a maximum of 12 cycles
Best Overall Tumor Response Rate, by Phase
Lasso di tempo: At each treatment cycle (21 to 35 days), for a maximum of 12 cycles
Biological activity of bendamustine was defined as achieving a best response of partial response (PR), CRp, or CR. Rate was calculated as follows: number of participants in the primary analysis set achieving a best overall response of PR, CRp, or CR, divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A PR had to meet the following criteria: complete disappearance of circulating blasts and an M2 marrow (≥ 5% and ≤ 25% bone marrow blasts) and appearance of normal progenitor cells or an M1 marrow that did not qualify for CR or CRp. See Outcome Measure 2 for full definitions for CRp and CR.
At each treatment cycle (21 to 35 days), for a maximum of 12 cycles
Duration of Response (DOR)
Lasso di tempo: At each treatment cycle (21 to 35 days), for a maximum of 12 cycles
DOR was determined for the participants with CR or CRp in the primary analysis set, defined as the time from first achieving remission to the time when progression was diagnosed, the participant died, or the participant started receiving new antineoplastic therapy. Data from participants who do not progress were censored at the last valid assessments. Median DOR and its 95% confidence interval was determined based on the Kaplan-Meier method. Data from participants who received a transplant were censored at the time of the transplant.
At each treatment cycle (21 to 35 days), for a maximum of 12 cycles
Maximum Observed Plasma Drug Concentration (Cmax) for Bendamustine and Its Metabolites (M3 and M4)
Lasso di tempo: Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.
Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.
Time to Maximum Plasma Drug Concentration (Tmax) for Bendamustine and Its Metabolites (M3 and M4)
Lasso di tempo: Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.
Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.
Area Under the Plasma Drug Concentration by Time Curve From Time 0 Until the Last Measurable Plasma Concentration (AUC0-t) for Bendamustine and Its Metabolites (M3 and M4)
Lasso di tempo: Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.
Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.
Area Under the Plasma Drug Concentration by Time Curve From Time 0 Until 24 Hours After Study Drug Administration (AUC0-24) for Bendamustine and Its Metabolites (M3 and M4)
Lasso di tempo: Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.
Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 2010

Completamento primario (Effettivo)

1 agosto 2011

Completamento dello studio (Effettivo)

1 agosto 2011

Date di iscrizione allo studio

Primo inviato

16 marzo 2010

Primo inviato che soddisfa i criteri di controllo qualità

16 marzo 2010

Primo Inserito (Stima)

18 marzo 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

23 maggio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 aprile 2016

Ultimo verificato

1 aprile 2016

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • C18083/2046
  • 2010-020768-40 (Numero EudraCT)

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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