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

NCT00073749

Last updated date
Study Location
UAB CCC Clinical Studies Unit
Birmingham, Alabama, 35233, 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.
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

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Advanced Information
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 Summary 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).
Detailed Description Not 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 Date December 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 Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2018

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