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出境医 / 临床实验 / Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab

Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab

Study Description
Brief Summary:
This is a non-interventional cohort study evaluating non-relapse mortality and toxicities in patients with CTCL or ATLL treated with mogamulizumab pre- or post- alloHCT for patients transplanted beginning January 1, 2012 until accrual is complete.

Condition or disease
Leukemia/Lymphoma

Detailed Description:

This is an observational, retrospective and prospective study where subjects who have received mogamulizumab either within one year before or within 18 months after transplantation will be followed for data collection. Data will be collected at baseline (retrospectively), 100 days post alloHCT, 6-months, 1 year and at 2 years post alloHCT (retrospectively and prospectively).

A cut-off time limit of 18 months post alloHCT exposure will allow at least 6 months of follow-up within the 2 years post-alloHCT follow-up period.

Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024
Arms and Interventions
Group/Cohort
Transplant Arm
Patients with CTCL or ATLL who received mogamulizumab within one year prior or up to 18 months after alloHCT
Control Arm
Patients who have undergone alloHCT without exposure to mogamulizumab pre- or post-alloHCT
Outcome Measures
Primary Outcome Measures :
  1. Assess toxicities or complications of transplant among patients who were treated with mogamulizumab, alone or in combination [ Time Frame: one year prior to alloHCT to within 18 months after alloHCT ]
    This study will utilize comprehensive report form (CRF) data, modified transplant essential data (TED) and supplemental data. In patients with only TED data the supplemental data will provide the required additional information for data analyses to meet the objectives of the study.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will include a minimum of 50 patients with CTCL or ATLL who received mogamulizumab within one year prior to alloHCT. At least 40 patients should have been diagnosed with CTCL and at least 33 patients should have received mogamulizumab as last therapy line before alloHCT. Data will be collected from no more than 100 controls with similar characteristics to the mogamulizumab-treated patients, and who have undergone alloHCT without exposure to mogamulizumab pre- or post-alloHCT. Information on patients receiving mogamulizumab within 18 months after alloHCT will also be collected.
Criteria

Inclusion Criteria:

  • Patients registered to the Center for International Blood and Marrow Transplant Research (CIBMTR)
  • Adults ≥18 years of age with either CTCL or ATLL;
  • AlloHCT performed from January 2012 onward.

Exclusion Criteria:

• Patients without consent for research.

Contacts and Locations

Locations
Layout table for location information
United States, Wisconsin
CIBMTR
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Kyowa Kirin, Inc.
Tracking Information
First Submitted Date July 9, 2019
First Posted Date July 10, 2019
Last Update Posted Date October 14, 2020
Actual Study Start Date September 10, 2019
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 12, 2019) 		Assess toxicities or complications of transplant among patients who were treated with mogamulizumab, alone or in combination [ Time Frame: one year prior to alloHCT to within 18 months after alloHCT ]
This study will utilize comprehensive report form (CRF) data, modified transplant essential data (TED) and supplemental data. In patients with only TED data the supplemental data will provide the required additional information for data analyses to meet the objectives of the study.
Original Primary Outcome Measures
 (submitted: July 9, 2019) 		Assess toxicities or complications of transplant [ Time Frame: one year prior to alloHCT to within 18 months after alloHCT ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab
Official Title Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab
Brief Summary This is a non-interventional cohort study evaluating non-relapse mortality and toxicities in patients with CTCL or ATLL treated with mogamulizumab pre- or post- alloHCT for patients transplanted beginning January 1, 2012 until accrual is complete.
Detailed Description

This is an observational, retrospective and prospective study where subjects who have received mogamulizumab either within one year before or within 18 months after transplantation will be followed for data collection. Data will be collected at baseline (retrospectively), 100 days post alloHCT, 6-months, 1 year and at 2 years post alloHCT (retrospectively and prospectively).

A cut-off time limit of 18 months post alloHCT exposure will allow at least 6 months of follow-up within the 2 years post-alloHCT follow-up period.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study population will include a minimum of 50 patients with CTCL or ATLL who received mogamulizumab within one year prior to alloHCT. At least 40 patients should have been diagnosed with CTCL and at least 33 patients should have received mogamulizumab as last therapy line before alloHCT. Data will be collected from no more than 100 controls with similar characteristics to the mogamulizumab-treated patients, and who have undergone alloHCT without exposure to mogamulizumab pre- or post-alloHCT. Information on patients receiving mogamulizumab within 18 months after alloHCT will also be collected.
Condition Leukemia/Lymphoma
Intervention Not Provided
Study Groups/Cohorts
  • Transplant Arm
    Patients with CTCL or ATLL who received mogamulizumab within one year prior or up to 18 months after alloHCT
  • Control Arm
    Patients who have undergone alloHCT without exposure to mogamulizumab pre- or post-alloHCT
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 Active, not recruiting
Estimated Enrollment
 (submitted: July 9, 2019) 		50
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2024
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients registered to the Center for International Blood and Marrow Transplant Research (CIBMTR)
  • Adults ≥18 years of age with either CTCL or ATLL;
  • AlloHCT performed from January 2012 onward.

Exclusion Criteria:

• Patients without consent for research.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04014374
Other Study ID Numbers SC18-09
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Kyowa Kirin, Inc.
Study Sponsor Kyowa Kirin, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Kyowa Kirin, Inc.
Verification Date October 2020

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