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Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma

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NCT00073749

Last updated on March 22, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233 United States
See other locations
Contact
1-800-718-1021
[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

- Subjects who have been previously diagnosed with CD22-positive, B-cell NHL, according
to WHO classification, which has progressed after at least 2 prior therapies of
probable clinical benefit

- At the expanded cohort, part 2 of the study, subjects must have one of the following:

- Follicular lymphoma previously treated with at least one dose of rituximab, but have
not received radioimmunotherapy

- Diffuse large B-cell lymphoma

- Age 18 years or older

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

- Candidate for potentially curative therapies in the opinion of the investigator

- Chronic lymphocytic leukemia

- Burkitt's lymphoma, primary effusion lymphoma, and precursor B-cell lymphoblastic
lymphoma

NCT00073749
Pfizer
Completed
Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma

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Pfizer Clinical Trials Contact Center

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[email protected]

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Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma
A Phase 1 Study Of CMC-544 Administered As A Single Agent In Subjects With B-Cell Non-Hodgkin's Lymphoma
To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lymphoma, B-Cell
Drug: Inotuzumab ozogamicin [CMC-544]
CMC-544, IV, dose escalation trial
Experimental: Inotuzumab ozogamicin
Inotuzumab ozogamicin, iv, dose escalation and expanded cohort at 1.8mg/m2
Intervention: Drug: Inotuzumab ozogamicin [CMC-544]
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2010
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who have been previously diagnosed with CD22-positive, B-cell NHL, according to WHO classification, which has progressed after at least 2 prior therapies of probable clinical benefit
  • At the expanded cohort, part 2 of the study, subjects must have one of the following:
  • Follicular lymphoma previously treated with at least one dose of rituximab, but have not received radioimmunotherapy
  • Diffuse large B-cell lymphoma
  • Age 18 years or older

Exclusion Criteria:

  • Candidate for potentially curative therapies in the opinion of the investigator
  • Chronic lymphocytic leukemia
  • Burkitt's lymphoma, primary effusion lymphoma, and precursor B-cell lymphoblastic lymphoma
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany,   Spain,   Switzerland,   United Kingdom,   United States
 
 
NCT00073749
3129K1-100
B1931002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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