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Besponsa Post Marketing Surveillance Study

Last updated on April 1, 2020

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hematologic Maligmancy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Patients must meet all of the following inclusion criteria to be eligible for inclusion in
the study:

1. Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia
(ALL).

2. Evidence of a personally signed and dated informed consent document indicating that
the patient (or a legally acceptable representative) has been informed of all
pertinent aspects of the study.

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

Patients meeting any of the following criteria will not be included in the study:

1. Any patients who does not agree that Pfizer and companies working with Pfizer use
his/her information.

2. Patients to whom BESPONSA® is contraindicated as per the local labeling.

-

NCT04307134
Pfizer
Not yet recruiting
Besponsa Post Marketing Surveillance Study

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Hematologic Maligmancy
NCT04307134
All Genders
Descriptive Information
Brief Title Besponsa Post Marketing Surveillance Study
Official Title Korean Post Marketing Surveillance Study to Observe Safety and Effectiveness of BESPONSA (REGISTERED)
Brief Summary Besponsa is approved for the treatment of R/R B-cell ALL in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with besponsa after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of besponsa will be observed.
Detailed Description Before the approval of BESPONSA® in Korea, this non-interventional study is designated as a Post-Marketing Surveillance (PMS) Study and is a commitment to Ministry of Food and Drug Safety (MFDS), as a part of Risk Management Plan (RMP) which is required by MFDS. The safety and effectiveness information of BESPONSA® will be gathered at minimum 160 subjects administered in the setting of routine practice in Korea during the initial 6 years after the approval.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL).
Condition Hematologic Maligmancy
Intervention Drug: Inotuzumab ozogamicin
R/R ALL who treated with Inotuzumab ozogamicin
Study Groups/Cohorts R/R ALL
Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL)
Intervention: Drug: Inotuzumab ozogamicin
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 Not yet recruiting
Estimated Enrollment
 (submitted: March 11, 2020)
160
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2, 2025
Estimated Primary Completion Date January 2, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  1. Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL).
  2. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion criteria

Patients meeting any of the following criteria will not be included in the study:

  1. Any patients who does not agree that Pfizer and companies working with Pfizer use his/her information.
  2. Patients to whom BESPONSA® is contraindicated as per the local labeling.

    -

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04307134
Other Study ID Numbers B1931027
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2020

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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