Study Evaluating Safety and Tolerability of Inotuzumab Ozogamicin (CMC-544) in Japanese Patients With B-cell Non-Hodgkin's Lymphoma (NHL)

NCT00717925

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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
20-74 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies.

- Patients who have progressed after at least 1 prior chemotherapy regimen for indolent lymphoma, or 1/ 2 chemotherapy regimens, which include anthracylin or anthraquinon for aggressive lymphoma.

- Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1.

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


- Patients must not have received monoclonal antibodies or radioimmunoconjugates within
3 months before first dose of test article.


- Patients must not have received bilateral pelvic irradiation.


- Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth
factors (except erythropoietin), or investigational agents within 4 weeks before first
dose of test article.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Safety and Tolerability of Inotuzumab Ozogamicin (CMC-544) in Japanese Patients With B-cell Non-Hodgkin's Lymphoma (NHL)
Official Title  ICMJE A Phase 1 Study Of CMC-544 Administered As A Single Agent In Subjects With B-Cell Non-Hodgkin's Lymphoma
Brief Summary To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in patients with B-Cell Non-Hodgkin's Lymphoma (NHL).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, B-Cell
Intervention  ICMJE Drug: Inotuzumab Ozogamicin (CMC-544)
Intravenous (IV) infusion, 1.3 - 1.8 mg/m2, every 28 days, 4 cycles
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Inotuzumab Ozogamicin (CMC-544)
Publications * Ogura M, Tobinai K, Hatake K, Uchida T, Kasai M, Oyama T, Suzuki T, Kobayashi Y, Watanabe T, Azuma T, Mori M, Terui Y, Yokoyama M, Mishima Y, Takahashi S, Ono C, Ohata J. Phase I study of inotuzumab ozogamicin (CMC-544) in Japanese patients with follicular lymphoma pretreated with rituximab-based therapy. Cancer Sci. 2010 Aug;101(8):1840-5. doi: 10.1111/j.1349-7006.2010.01601.x. Epub 2010 Apr 23.

*   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, 2008)
13
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies.
  • Patients who have progressed after at least 1 prior chemotherapy regimen for indolent lymphoma, or 1/ 2 chemotherapy regimens, which include anthracylin or anthraquinon for aggressive lymphoma.
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1.

Exclusion Criteria:

  • Patients must not have received monoclonal antibodies or radioimmunoconjugates within 3 months before first dose of test article.
  • Patients must not have received bilateral pelvic irradiation.
  • Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 4 weeks before first dose of test article.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 74 Years   (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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00717925
Other Study ID Numbers  ICMJE 3129K1-103
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP