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Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma

perjantai 14. joulukuuta 2018 päivittänyt: Pfizer

A Phase 1 Study Of Cmc-544 Administered As A Single Agent In Subjects With B-cell Non- Hodgkin's Lymphoma

To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

79

Vaihe

  • Vaihe 1

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Belgia
      • Leuven, Belgia, 3000
        • Universitair Ziekenhuis Gasthuisberg
  • Espanja
      • Barcelona, Espanja, 08025
        • Hospital de La Santa Creu i Sant Pau
      • Barcelona, Espanja, 08036
        • Hospital Clinic I Provincial
  • Ranska
      • Paris, Ranska, 75010
        • Hopital Saint Louis
      • Pierre Benite Cedex, Ranska, 69495
        • Centre Hospitalier Lyon-Sud
  • Saksa
      • Mainz, Saksa, 55131
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet
      • Muenchen, Saksa, 81377
        • Medizinische Klinik und Poliklinik III, Klinikum der Universitat Muenchen-Grosshadern
      • Muenchen, Saksa, 81377
        • Universitaet Muenchen Klinikum Grosshadern
    • NRW
      • Bonn, NRW, Saksa, 53105
        • Universitatsklinikum Bonn
  • Sveitsi
      • Lausanne, Sveitsi, 1011
        • Centre Hospitalier Universitaire Vaudois
  • Yhdistynyt kuningaskunta
      • London, Yhdistynyt kuningaskunta, EC1A 7BE
        • St Bartholomew's Hospital
  • Yhdysvallat
    • Alabama
      • Birmingham, Alabama, Yhdysvallat, 35294
        • University of Alabama at Birmingham
      • Birmingham, Alabama, Yhdysvallat, 35233
        • UAB CCC Clinical Studies Unit
      • Birmingham, Alabama, Yhdysvallat, 35233
        • University of Alabama at Birmingham Kirklin Clinic
      • Birmingham, Alabama, Yhdysvallat, 35294
        • UAB Russell Ambulatory Pharmacy
    • Illinois
      • Chicago, Illinois, Yhdysvallat, 60611
        • Northwestern Memorial Hospital
      • Chicago, Illinois, Yhdysvallat, 60611
        • Northwestern Medical Faculty Foundation
    • New York
      • Buffalo, New York, Yhdysvallat, 14263
        • Roswell Park Cancer Institute
    • Ohio
      • Cleveland, Ohio, Yhdysvallat, 44195
        • The Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, Yhdysvallat, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Yhdysvallat, 19104
        • University of Pennsylvania
    • Texas
      • Houston, Texas, Yhdysvallat, 77030-4009
        • M.D. Anderson Cancer Center

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 99 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

  • Subjects who have been previously diagnosed with CD22-positive, B-cell NHL, according to WHO classification, which has progressed after at least 2 prior therapies of probable clinical benefit
  • At the expanded cohort, part 2 of the study, subjects must have one of the following:
  • Follicular lymphoma previously treated with at least one dose of rituximab, but have not received radioimmunotherapy
  • Diffuse large B-cell lymphoma
  • Age 18 years or older

Exclusion Criteria:

  • Candidate for potentially curative therapies in the opinion of the investigator
  • Chronic lymphocytic leukemia
  • Burkitt's lymphoma, primary effusion lymphoma, and precursor B-cell lymphoblastic lymphoma

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei satunnaistettu
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Inotuzumab ozogamicin
Inotuzumab ozogamicin, iv, dose escalation and expanded cohort at 1.8mg/m2
Lääke: Inotuzumab ozogamicin [CMC-544]
CMC-544, IV, dose escalation trial

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Aikaikkuna: Baseline up to 42 days after last dose of study drug (up to Day 225)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAE) are defined as any new event reported after first dose of study drug up to 42 days after last dose of study drug, or any event that is worse in severity than at any time during the baseline period. AEs included both SAEs and non-serious adverse events (non-SAEs).
Baseline up to 42 days after last dose of study drug (up to Day 225)
Number of Participants With Grade 3 or Higher Grades Treatment-Emergent Adverse Events (TEAEs) Based on Severity
Aikaikkuna: Baseline up to 42 days after last dose of study drug (up to Day 225)
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE severity was defined to be the maximum toxicity grade of the treatment-emergent adverse events (TEAEs) experienced by the participants during the study. AE was assessed according to severity; Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening or disabling AE), Grade 5 (death related to AE). Participants with Grade 3 or higher grades TEAEs were reported.
Baseline up to 42 days after last dose of study drug (up to Day 225)
Maximum Tolerated Dose (MTD): Part 1 (Dose Escalation Cohorts)
Aikaikkuna: Baseline up to Day 28
MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT). DLT was defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to [>=] 7 days), delayed recovery (less than or equal to [<=] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 2 weeks.
Baseline up to Day 28
Number of Participants With Dose-limiting Toxicity (DLT)
Aikaikkuna: Baseline up to Day 28
DLT was classified as per National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 3.0 and defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to [>=] 7 days), delayed recovery (less than or equal to [<=] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 14 days.
Baseline up to Day 28

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Progression-Free Survival (PFS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)
Aikaikkuna: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
PFS was based on Kaplan-Meier estimates. PFS was defined as the time interval from the first dose of study medication until the first date on which relapsed disease, or progression (as per the International Response Criteria for Non-Hodgkin Lymphoma) or death, was documented, censored at the last tumor evaluation date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
Progression-Free Survival (PFS): Intent-to-treat Population-Part 2 (Lead-in + Expanded Cohorts)
Aikaikkuna: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
PFS was based on Kaplan-Meier estimates. PFS was defined as the time interval from the first dose of study medication until the first date on which relapsed disease, or progression (as per International Response Criteria for Non-Hodgkin Lymphoma) or death, was documented, censored at the last tumor evaluation date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
Overall Survival (OS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)
Aikaikkuna: Baseline up to Year 5
OS was based on Kaplan-Meier method. Survival was defined as the time period from the first dose of study drug until the date of death, censored at the participant's last contact date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
Baseline up to Year 5
Overall Survival (OS): Intent-to-treat Population: Part 2 (Lead-in + Expanded Cohorts)
Aikaikkuna: Baseline up to Year 5
Interval OS was based on Kaplan-Meier method. Survival was defined as the time period from the first dose of study drug until the date of death, censored at the participant's last contact date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
Baseline up to Year 5
Number of Participants With Best Overall Response (BOR): Part 2 (Expanded Cohorts)
Aikaikkuna: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
Participants with BOR=with complete response(CR),unconfirmed CR(CRu) or partial response (PR) as per International Response Criteria for NHL. CR: Total disappearance of all detectable clinical,radiographic sign of disease/related symptoms,normalization biochemical abnormalities related to NHL;if enlarged before therapy all lymph nodes,nodal masses,other organs regressed to normal size and spleen regressed in size,undetectable on physical exam,clear bone marrow infiltrate. CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow. PR:>=50% decrease in sum of products of greatest diameters(SPD) of 6 largest dominant nodes/nodal masses,no increase in size of other nodes/spleen/liver, 50% decrease in SPD of splenic,hepatic nodules,involvement of other organs considered assessable,not measurable disease with exception of splenic,hepatic nodules.
Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
Duration of Overall Response (DoR): Part 2 (Lead-in + Expanded Cohorts)
Aikaikkuna: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
Duration of overall response was defined as the time from the date that measurement criteria were met for CR, CRu, or PR (whichever status was recorded first) until the first date that relapsed disease was objectively documented as per International Response Criteria for NHL, taking as reference for relapsed disease the smallest measurements recorded since the treatment started. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
Time-to-Tumor Progression: Part 2 (Expanded Cohorts)
Aikaikkuna: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
Time to tumor progression was defined as the interval from the start of the treatment until the first date on which relapsed disease or progression is documented, censored at the last disease assessment. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Percentage of Participants With Objective Response- Evaluable Population: Part 2 (Lead-in + Expanded Cohorts)
Aikaikkuna: Baseline up to 42 days after last dose (Day 225)
Participants (having follicular or diffuse lymphoma) with objective response based assessment of CR, CRu or PR as per International Response Criteria for NHL. CR: Total disappearance of all detectable clinical, radiographic sign of disease/related symptoms, normalization biochemical abnormalities related to NHL; if enlarged before therapy all lymph nodes, nodal masses, other organs regressed to normal size and spleen regressed in size, undetectable on physical exam, clear bone marrow infiltrate. CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow. PR: >=50% decrease in SPD of 6 largest dominant nodes or nodal masses, no increase in size of other nodes, spleen or liver, 50% decrease in SPD of splenic, hepatic nodules, involvement of other organs considered assessable, not measurable disease with exception of splenic, hepatic nodules.
Baseline up to 42 days after last dose (Day 225)
Percentage of Participants With Objective Response- Intent-to-treat Population: Part 2 (Lead in+ Expanded Cohorts)
Aikaikkuna: Baseline up to 42 days after last dose of study drug (Day 225)
Participants (having follicular or diffuse lymphoma) with objective response based assessment of CR, CRu or PR as per International Response Criteria for NHL. CR: Total disappearance of all detectable clinical, radiographic sign of disease/related symptoms, normalization biochemical abnormalities related to NHL; if enlarged before therapy all lymph nodes, nodal masses, other organs regressed to normal size and spleen regressed in size, undetectable on physical exam, clear bone marrow infiltrate. CRu: CR but allows for residual lymph node mass >1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by >75% in product diameters and indeterminate bone marrow. PR: >=50% decrease in SPD of 6 largest dominant nodes or nodal masses, no increase in size of other nodes, spleen or liver, 50% decrease in SPD of splenic, hepatic nodules, involvement of other organs considered assessable, not measurable disease with exception of splenic, hepatic nodules.
Baseline up to 42 days after last dose of study drug (Day 225)

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Pfizer

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Perjantai 1. elokuuta 2003

Ensisijainen valmistuminen (Todellinen)

Keskiviikko 1. joulukuuta 2010

Opintojen valmistuminen (Todellinen)

Keskiviikko 1. joulukuuta 2010

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 4. joulukuuta 2003

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 4. joulukuuta 2003

Ensimmäinen Lähetetty (Arvio)

Perjantai 5. joulukuuta 2003

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 17. joulukuuta 2018

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 14. joulukuuta 2018

Viimeksi vahvistettu

Lauantai 1. joulukuuta 2018

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 3129K1-100
  • B1931002 (Muu tunniste: Alias Study Number)

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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