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

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NCT00073749

Last updated on November 29, 2019
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Study Location
UAB CCC Clinical Studies Unit
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
18-99 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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Descriptive Information
Brief Title  ICMJE Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma
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 SummaryTo 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).
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
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]
CMC-544, IV, dose escalation trial
Study Arms  ICMJE Experimental: Inotuzumab ozogamicin
Inotuzumab ozogamicin, iv, dose escalation and expanded cohort at 1.8mg/m2
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: January 11, 2018)		79
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion DateDecember 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 99 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 Belgium,   France,   Germany,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00073749
Other Study ID Numbers  ICMJE 3129K1-100
B1931002 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2018

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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1-800-718-1021

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