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Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma

30 października 2017 zaktualizowane przez: Pfizer

An Open-label, Single-arm, Phase 2 Study Of Inotuzumab Ozogamicin Plus Rituximab In Subjects With Relapsed/Refractory Cd22-positive Diffuse Large B-cell Lymphoma, Eligible For Autologous Stem Cell Transplantation

The purpose of this study is to evaluate inotuzumab ozogamicin in combination with rituximab prior to an autologous stem cell transplant (aSCT) in patients with relapsed/refractory diffuse large B-cell Non-Hodgkin's lymphoma.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

64

Faza

  • Faza 2

Kontakty i lokalizacje

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

Lokalizacje studiów

  • Francja
      • Lille, Francja, 59037
        • Chru de Lille Hopital Claude Huriez
      • Marseille, Francja, 13273
        • Institut Paoli Calmettes
      • Montpellier Cedex 5, Francja, 34295
        • CHU Saint-Eloi
      • Paris, Francja, 75010
        • Hôpital Saint louis
      • Pessac, Francja, 33604
        • Hôpital Haut-Lévèque
      • Pierre-Benite cedex 114, Francja, 69495
        • CH Lyon sud
      • Pierre-benite Cedex, Francja, 69495
        • CH Lyon sud
      • Strasbourg, Francja, 67098
        • Departement d'Hematologie et d'Oncologie-
  • Niemcy
      • Berlin, Niemcy, 13353
        • Charite Campus Virchow-Kilinikum-
  • Republika Korei
      • Seoul, Republika Korei, 120-752
        • Severance Hospital, Yonsei University Health System
    • Gangnam-gu
      • Seoul, Gangnam-gu, Republika Korei, 135-710
        • Samsung Medical Center
    • Seoul/korea
      • Seoul, Seoul/korea, Republika Korei, 138-736
        • Asan Medical Center
  • Singapur
      • Singapore, Singapur, 169608
        • Singapore General Hospital
  • Stany Zjednoczone
    • Illinois
      • Maywood, Illinois, Stany Zjednoczone, 60153
        • Loyola University Medical Center, Foster G. McGraw Hospital and Satellites
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, Stany Zjednoczone, 48109
        • University of Michigan Comprehensive Cancer Center
    • Missouri
      • Saint Louis, Missouri, Stany Zjednoczone, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, Stany Zjednoczone, 63110-1094
        • Barnes-Jewish Hospital
      • Saint Peters, Missouri, Stany Zjednoczone, 63376
        • Siteman Cancer Center
    • New Jersey
      • Hackensack, New Jersey, Stany Zjednoczone, 07601
        • Hackensack University Medical Center
      • Hackensack, New Jersey, Stany Zjednoczone, 07601
        • John Theurer Cancer Center, Hackensack University Medical Center
      • Hackensack, New Jersey, Stany Zjednoczone, 07601-1941
        • John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC)
      • Hackensack, New Jersey, Stany Zjednoczone, 07601-2105
        • John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC)
      • Hackensack, New Jersey, Stany Zjednoczone, 07601
        • John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC)
    • New York
      • New York, New York, Stany Zjednoczone, 10065
        • Memorial Sloan - Kettering Cancer Center
    • Pennsylvania
      • Hershey, Pennsylvania, Stany Zjednoczone, 17033-0850
        • Penn State Milton S Hershey Medical Center
    • Texas
      • Dallas, Texas, Stany Zjednoczone, 75390
        • UT Southwestern Medical Center
      • Dallas, Texas, Stany Zjednoczone, 75235
        • Zale Lipshy University Hospital
      • Dallas, Texas, Stany Zjednoczone, 75235
        • UT Southwestern University Hospital - St. Paul
      • Houston, Texas, Stany Zjednoczone, 77030
        • University of Texas, MD Anderson Cancer Center
      • Houston, Texas, Stany Zjednoczone, 77030-4009
        • The University of Texas, M. D. Anderson Cancer Center
      • San Antonio, Texas, Stany Zjednoczone, 78229
        • Methodist Healthcare System of
    • Wisconsin
      • Madison, Wisconsin, Stany Zjednoczone, 53792-0001
        • University of Wisconsin Hospital and Clinics
      • Madison, Wisconsin, Stany Zjednoczone, 53792
        • Pharmaceutical Research Center
  • Zjednoczone Królestwo
      • Manchester, Zjednoczone Królestwo, M20 4BX
        • The Christie NHS Foundation Trust
      • Manchester, Zjednoczone Królestwo, M20 4BX
        • Christie 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 i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • CD20/CD22-positive diffuse large B-cell NHL that has relapsed after 1 or 2 prior therapies; one prior therapy must include anthracyclines and one must include rituximab in combination with chemotherapy
  • Relapsed/disease progression within 12 months after start of prior therapy and/or secondary International Prognostic Index (sIPI) score greater than 1
  • Eligible for autologous stem cell transplant (aSCT)

Exclusion Criteria:

  • Prior allogeneic hematopoietic stem cell transplant
  • Within 6 months prior to test article: autologous transplant, treatment with anti-CD22 antibodies, radio-immunotherapy
  • Veno-occlusive disease or sinusoidal obstruction syndrome, chronic liver disease, systemic vasculitides, current or chronic hepatitis B or C infection

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: Rituximab 375 mg/m^2 + Inotuzumab Ozogamicin 1.8 mg/m^2
Inotuzumab ozogamicin, in combination with rituximab, will be administered to patients with relapsed/refractory diffuse large B-cell Non-Hodgkin's lymphoma prior to an autologous stem cell transplant (aSCT).
Lek: inotuzumab ozogamicin (CMC-544)
1.8 mg/m^2 every 21 days by intravenous infusion, 3 to 6 doses
Inne nazwy:
  • cmc-544
Lek: rituximab
375 mg/m^2 two days before cycle 1 by intravenous infusion; 375 mg/m^2 every 21 days by intravenous infusion, 3 to 6 doses

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy
Ramy czasowe: Up to 2 years (9 weeks of 3 21-day cycles and every 3 to 6 months during the long-term follow-up period)
Response criteria based on National Cancer Institute (NCI) International Response Criteria for non-Hodgkin's lymphoma. CR: no detectable clinical & radiographic evidence of disease/disease-related symptoms; lymph nodes/nodal masses regressed to normal size (less than or equal to [≤] 1.5 cm in greatest transverse diameter for nodes greater than [>] 1.5 cm pre-therapy); spleen & other organs (if enlarged pre-therapy) regressed in size & spleen not palpable on physical examination; repeat bone marrow infiltrate clear. PR: > or equal to (≥) 50% decrease in sum of product diameters (SPD) of 6 largest dominant nodes/nodal masses; no increase in size of other nodes, liver, or spleen; splenic & hepatic nodules regressed by ≥ 50% in SPD; involvement of other organs usually assessable & no measurable disease present; no new sites of disease. Participants achieving CR, but with persistent morphologic bone marrow involvement or no bone marrow assessment after treatment were partial responders.
Up to 2 years (9 weeks of 3 21-day cycles and every 3 to 6 months during the long-term follow-up period)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Kaplan-Meier Estimate of Progression Free Survival (PFS) 6 Months After Inotuzumab Ozogamicin Plus Rituximab Therapy
Ramy czasowe: 6 months after the first dose of inotuzumab ozogamicin
PFS; time from date of randomization to earliest date of progression, relapse after CR, death from any cause without progression, start of new treatment for the lymphoma excluding treatments/procedures for consolidation therapy in this protocol, or censored at date of last tumor assessment. Progression: abnormal lymph nodes (long axis > 1.5 cm or long axis 1.1 to 1.5 cm and short axis > 1.0 cm); appearance of any new lesion > 1.5 cm in any axis during or at end of treatment; ≥ 50% increase from nadir in SPD of any previously involved nodes, in a single involved node, or in the size of other lesions; ≥ 50% increase in longest diameter of any single previously identified node > 1.0 cm in short axis.
6 months after the first dose of inotuzumab ozogamicin
Kaplan-Meier Estimate of PFS 2 Years After Inotuzumab Ozogamicin Plus Rituximab Therapy
Ramy czasowe: 2 years after the first dose of inotuzumab ozogamicin
PFS; time from date of randomization to earliest date of progression, relapse after CR, death from any cause without progression, start of new treatment for the lymphoma excluding treatments/procedures for consolidation therapy in this protocol, or censored at date of last tumor assessment. Progression: abnormal lymph nodes (long axis > 1.5 cm or long axis 1.1 to 1.5 cm and short axis > 1.0 cm); appearance of any new lesion > 1.5 cm in any axis during or at end of treatment; ≥ 50% increase from nadir in SPD of any previously involved nodes, in a single involved node, or in the size of other lesions; ≥ 50% increase in longest diameter of any single previously identified node > 1.0 cm in short axis.
2 years after the first dose of inotuzumab ozogamicin
Percentage of Participants With a Response of CR or PR and Who Had Successful Granulocyte Colony Stimulating Factor (G-CSF) Mobilization of Peripheral Blood Stem Cells (PBSCs) Overall and After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy
Ramy czasowe: From the first dose to approximately 2 to 3 weeks after 3 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 12 weeks) and up to approximately 2 to 3 weeks after 6 cycles (up to 21 weeks).
Successful mobilization of PBSC: ≥ 2 x 10^6 cluster of differentiation (CD) 34+ cells per kilogram (cells/kg) after 3 cycles. CR: no detectable clinical & radiographic evidence of disease/disease-related symptoms; lymph nodes/nodal masses regressed to normal size (≤ 1.5 cm in greatest transverse diameter for nodes > 1.5 cm pre-therapy); spleen & other organs (if enlarged pre-therapy) regressed in size & spleen not palpable on physical examination; repeat bone marrow infiltrate clear. PR: ≥ 50% decrease in SPD of 6 largest dominant nodes/nodal masses; no increase in size of other nodes, liver, or spleen; splenic & hepatic nodules regressed by ≥ 50% in SPD; involvement of other organs usually assessable & no measurable disease present; no new sites of disease. Participants achieving CR, but with persistent morphologic bone marrow involvement or no bone marrow assessment post treatment were partial responders. Response includes confirmed CR/PR and unconfirmed CR/PR.
From the first dose to approximately 2 to 3 weeks after 3 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 12 weeks) and up to approximately 2 to 3 weeks after 6 cycles (up to 21 weeks).
Percentage of Participants With Successful G-CSF Mobilization of PBSC
Ramy czasowe: From the first dose to approximately 2 to 3 weeks after up to 6 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 21 weeks).
Successful mobilization of PBSC was defined as ≥ 2 x 10^6 CD34+ cells/kg collected after 3 cycles of inotuzumab ozogamicin plus rituximab therapy.
From the first dose to approximately 2 to 3 weeks after up to 6 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 21 weeks).
Percentage of Participants Who Underwent Autologous Stem Cell Transplant (aSCT)
Ramy czasowe: A minimum of 4 weeks and a maximum of 8 weeks after the last cycle of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 26 weeks).
Participants underwent high dose chemotherapy and aSCT. In order to proceed to aSCT, participants were required to achieve CR or PR and successful collection of PSBC (≥ 2.0 x 10^6 CD34+ cells/kg collected after 3 cycles).
A minimum of 4 weeks and a maximum of 8 weeks after the last cycle of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 26 weeks).
Event-Free Survival (EFS) After aSCT
Ramy czasowe: From the completion of aSCT through 2 year long-term follow-up period, including but not limited to planned assessments scheduled every 3 to 6 months.
EFS was the time (in months) from the date of aSCT to the earliest date of progression, relapse after CR, death from any cause without progression, initiation of a new treatment for the lymphoma or was censored at the date of the last tumor assessment.
From the completion of aSCT through 2 year long-term follow-up period, including but not limited to planned assessments scheduled every 3 to 6 months.
Percentage of Participants With a CR After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy
Ramy czasowe: From the first dose to approximately 2 to 3 weeks after 3 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 12 weeks).
CR: complete disappearance of all detectable clinical & radiographic evidence of disease & disease-related symptoms; lymph nodes & nodal masses regressed to normal size (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy); spleen and other organs (if enlarged prior to therapy) regressed in size & spleen not palpable on physical examination; repeat bone marrow infiltrate clear. Response includes confirmed CR and unconfirmed CR.
From the first dose to approximately 2 to 3 weeks after 3 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 12 weeks).
Overall Survival (OS)
Ramy czasowe: From randomization until the date of death, or the date of last contact if no death occurred (up to 2 years).
OS was the time (in months) from the date of randomization to the date of death, and censored at the date of last contact if no death occurred.
From randomization until the date of death, or the date of last contact if no death occurred (up to 2 years).
Percentage of Participants With Any Grade 3/4 Laboratory Abnormality During Therapy
Ramy czasowe: Within 3 days prior each dose of test article, on Day -2, 1, 8, and 15 of Cycles 1 to 3, 2 to 3 weeks after Cycle 3, at the end-of-treatment visit, and every 3 to 6 months during long-term follow-up (up to 2 years).
The following parameters were analyzed for serum chemistry; blood urea nitrogen (or urea), creatinine, glucose, calcium, sodium, potassium, phosphorus, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, total bilirubin (and direct bilirubin, if total bilirubin was elevated), alkaline phosphatase, uric acid (or urate), albumin and total protein. The following parameters were analyzed for hematology; lymphocytes, basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, monocytes, neutrophils, platelets, prothrombin international normalized ratio, prothrombin time, fibrinogen, and activated partial thromboplastin time. Laboratory test results were graded using the NCI Common Terminology Criteria for Adverse Events, version 3.0 (CTCAE v3.0).
Within 3 days prior each dose of test article, on Day -2, 1, 8, and 15 of Cycles 1 to 3, 2 to 3 weeks after Cycle 3, at the end-of-treatment visit, and every 3 to 6 months during long-term follow-up (up to 2 years).
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) During Inotuzumab Ozogamicin Plus Rituximab Treatment
Ramy czasowe: Treatment emergent AEs were collected from time of first dose to end of trial visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs were collected from informed consent until end of trial visit (up to 6 months).
An AE was any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory/physiologic observations occurring in a participant given a test article or in a clinical study; the event may not necessarily have had a causal relationship with the treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; cancer. Treatment-emergent AEs were AEs that emerged after the first dose of the study treatment during the treatment period that were absent pre-treatment, or worsened during the treatment period relative to the pre-treatment state. The severity of all AEs was graded by the investigator using the NCI Common Terminology Criteria for AE Version 3.0 (CTCAE v3.0).
Treatment emergent AEs were collected from time of first dose to end of trial visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs were collected from informed consent until end of trial visit (up to 6 months).

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Pfizer

Współpracownicy

UCB Pharma

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)

8 czerwca 2009

Zakończenie podstawowe (Rzeczywisty)

31 października 2012

Ukończenie studiów (Rzeczywisty)

31 października 2012

Daty rejestracji na studia

Pierwszy przesłany

20 marca 2009

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 marca 2009

Pierwszy wysłany (Oszacować)

23 marca 2009

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 grudnia 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 października 2017

Ostatnia weryfikacja

1 października 2017

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 3129K5-2005
  • B1931001 (Inny identyfikator: Alias Study Number)
  • 2008-007802-12 (Numer EudraCT)

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

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

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