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

30 oktober 2017 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

64

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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).
Läkemedel: inotuzumab ozogamicin (CMC-544)
1.8 mg/m^2 every 21 days by intravenous infusion, 3 to 6 doses
Andra namn:
  • cmc-544
Läkemedel: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Kaplan-Meier Estimate of Progression Free Survival (PFS) 6 Months After Inotuzumab Ozogamicin Plus Rituximab Therapy
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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).

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Pfizer

Samarbetspartners

UCB Pharma

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

8 juni 2009

Primärt slutförande (Faktisk)

31 oktober 2012

Avslutad studie (Faktisk)

31 oktober 2012

Studieregistreringsdatum

Först inskickad

20 mars 2009

Först inskickad som uppfyllde QC-kriterierna

20 mars 2009

Första postat (Uppskatta)

23 mars 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 december 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 oktober 2017

Senast verifierad

1 oktober 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 3129K5-2005
  • B1931001 (Annan identifierare: Alias Study Number)
  • 2008-007802-12 (EudraCT-nummer)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Lymfom, B-cell

Kliniska prövningar på inotuzumab ozogamicin (CMC-544)

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