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

14 grudnia 2018 zaktualizowane przez: 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).

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

79

Faza

  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 99 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Inotuzumab ozogamicin
Inotuzumab ozogamicin, iv, dose escalation and expanded cohort at 1.8mg/m2
Lek: Inotuzumab ozogamicin [CMC-544]
CMC-544, IV, dose escalation trial

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Progression-Free Survival (PFS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants With Objective Response- Evaluable Population: Part 2 (Lead-in + Expanded Cohorts)
Ramy czasowe: 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)
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Pfizer

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 sierpnia 2003

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2010

Ukończenie studiów (Rzeczywisty)

1 grudnia 2010

Daty rejestracji na studia

Pierwszy przesłany

4 grudnia 2003

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 grudnia 2003

Pierwszy wysłany (Oszacować)

5 grudnia 2003

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

17 grudnia 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 grudnia 2018

Ostatnia weryfikacja

1 grudnia 2018

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 3129K1-100
  • B1931002 (Inny identyfikator: Alias Study Number)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Chłoniak z komórek B

Badania kliniczne na Inotuzumab ozogamicin [CMC-544]

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Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

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Warunki

Rzadkie choroby

Interwencje lekowe

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Lokalizacje

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