Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma

NCT00868608

Last updated date
Study Location
University of Alabama Birmingham
Birmingham, Alabama, 35294-3300, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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

- Subjects who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone, or small lymphocytic lymphoma) that has progressed after 2 or more prior systemic therapies.

- Previous anticancer treatment given must have contained rituximab and chemotherapy, or anti CD20 Radio Immuno Therapy. Subjects must have exhibited no response or have progressed within 6 months from the completion of the most recent rituximab or rituximab containing therapy or within 12 months of the completion of Radio Immuno Therapy.

- Measurable disease with adequate bone marrow function, renal and hepatic function

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


- History of, or suggestive of, veno-occlusive disease (VOD) or sinusoidal obstruction
syndrome (SOS) or history of chronic liver disease (eg, cirrhosis) or suspected
alcohol abuse.


- Prior allogeneic hematopoietic stem cell transplant (HSCT).


- Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade
3b follicular lymphoma.

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  1. Birmingham, Alabama
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  4. Loma Linda, California
  5. Loma Linda, California
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  7. Mission Hills, California
  8. Mission Hills, California
  9. Chicago, Illinois
  10. Saint Louis Park, Minnesota
  11. Saint Louis, Missouri
  12. Saint Louis, Missouri
  13. Hackensack, New Jersey
  14. Hackensack, New Jersey
  15. Hawthorne, New York
  16. Allentown, Pennsylvania
  17. Carlisle, Pennsylvania
  18. Hershey, Pennsylvania
  19. Lewistown, Pennsylvania
  20. Philadelphia, Pennsylvania
  21. State College, Pennsylvania
  22. Houston, Texas
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  12. Rochester, New York
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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Inotuzumab Ozogamicin (CMC-544) In Indolent Non-Hodgkins Lymphoma
Official Title  ICMJE A Phase 2 Study Of Inotuzumab Ozogamicin (Cmc-544) In Subjects With Indolent Non-hodgkin's Lymphoma (Nhl) That Is Refractory To Or Has Relapsed After Rituximab And Chemotherapy Or Radioimmunotherapy
Brief Summary The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (CMC-544) in subjects with indolent Non-Hodgkins lymphoma (NHL) that is refractory or has relapsed after multiple therapies including rituximab or radioimmunotherapy. The investigational drug will be given to subjects with indolent NHL by intravenous infusion at a dose of 1.8 mg/m2, every 4 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE Drug: Inotuzumab Ozogamicin (CMC-544)
Administered intravenously at 1.8 mg/m2 every 4 weeks for a planned 4 - 8 cycles
Other Name: inotuzumab ozogamicin
Study Arms  ICMJE Experimental: inotuzumab ozogamicin
inotuzumab ozogamicin
Intervention: Drug: Inotuzumab Ozogamicin (CMC-544)
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 17, 2013)
81
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2009)
60
Actual Study Completion Date  ICMJE June 27, 2013
Actual Primary Completion Date January 10, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who have been previously diagnosed with CD22-positive, indolent NHL (defined as follicular, marginal zone, or small lymphocytic lymphoma) that has progressed after 2 or more prior systemic therapies.
  • Previous anticancer treatment given must have contained rituximab and chemotherapy, or anti CD20 Radio Immuno Therapy. Subjects must have exhibited no response or have progressed within 6 months from the completion of the most recent rituximab or rituximab containing therapy or within 12 months of the completion of Radio Immuno Therapy.
  • Measurable disease with adequate bone marrow function, renal and hepatic function

Exclusion Criteria:

  • History of, or suggestive of, veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS) or history of chronic liver disease (eg, cirrhosis) or suspected alcohol abuse.
  • Prior allogeneic hematopoietic stem cell transplant (HSCT).
  • Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.
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 Belgium,   Germany,   Hong Kong,   Hungary,   Japan,   Korea, Republic of,   Netherlands,   Singapore,   United States
Removed Location Countries Denmark
 
Administrative Information
NCT Number  ICMJE NCT00868608
Other Study ID Numbers  ICMJE 3129K7-2001
B1931007 ( Other Identifier: Alias Study Number )
2008-001635-34 ( 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 CenterPfizer
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