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

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NCT00867087

Last updated on December 7, 2019
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FOR MORE INFORMATION
Study Location
Loyola University Medical Center, Foster G. McGraw Hospital and Satellites
Maywood, Illinois, 60153 United States
See other locations
Contact
1-800-718-1021
ClinicalTrials.gov[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
B-Cell Lymphoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00867087
Pfizer
Completed
Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma

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Descriptive Information
Brief Title  ICMJE Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, B-Cell
Intervention  ICMJE
  • Drug: inotuzumab ozogamicin (CMC-544)
    1.8 mg/m^2 every 21 days by intravenous infusion, 3 to 6 doses
    Other Name: cmc-544
  • Drug: 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
Study Arms  ICMJE Experimental: 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).
Interventions:
  • Drug: inotuzumab ozogamicin (CMC-544)
  • Drug: rituximab
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2017) 		64
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2009) 		60
Actual Study Completion Date  ICMJE October 31, 2012
Actual Primary Completion Date October 31, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Korea, Republic of,   Singapore,   United Kingdom,   United States
Removed Location Countries Hong Kong,   Japan,   Mexico,   Poland
 
Administrative Information
NCT Number  ICMJE NCT00867087
Other Study ID Numbers  ICMJE 3129K5-2005
B1931001 ( Other Identifier: Alias Study Number )
2008-007802-12 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE UCB Pharma
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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