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Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia

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ClinicalTrials.gov Identifier: NCT02677064
Recruitment Status : Recruiting
First Posted : February 9, 2016
Last Update Posted : January 24, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
The investigators are doing this research study to assess the percentage of patients receiving stem cell transplantation for the type of blood cancer you have. They want to know how many patients get a transplant and why some patients do get a transplant while others do not. Also they want to explore why some patients elect not to undergo stem cell transplantation, when it is recommended by their physicians.

Condition or disease Intervention/treatment
Acute Leukemia Newly Diagnosed Relapsed Other: assessments

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study to Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia
Study Start Date : February 2016
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Groups and Cohorts
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Group/Cohort Intervention/treatment
patients with acute leukemia (AML or ALL) Other: assessments
Thus, a prospective observational study in which all newly diagnosed or newly relapsed acute leukemia patients would be registered close to the beginning of induction or re-induction therapy would allow us to follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible.


Outcome Measures
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Primary Outcome Measures :
  1. number of patients who proceed to transplant [ Time Frame: 3 years ]
    determine whether an individual patient proceeded to HCT when he or she was considered eligible (based on NCCN guidelines.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with acute leukemia (AML or ALL) who are admitted to the Leukemia Service for induction or re-induction therapy.
Criteria

Inclusion Criteria:

  • Patients with newly diagnosed or relapsed acute leukemia. Patients undergoing reinduction due to primary induction failure are also eligible.
  • 18 years of age or older and 75 years of age or younger, admitted for treatment on the Adult Leukemia Service.

Exclusion Criteria:

  • Patients with relapsed acute leukemia post-allogeneic transplant
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02677064


Contacts
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Contact: Boglarka Gyurkocza, MD ABMTTrials@mskcc.org
Contact: Sergio Giralt, MD ABMTTrials@mskcc.org

Locations
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United States, Connecticut
Hartford Healthcare Cancer Institute @ Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Mark Dailey, MD    860-249-6291      
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Boglarka Gyurkocza, MD       ABMTTrials@mskcc.org   
Contact: Sergio Giralt, MD       ABMTTrials@mskcc.org   
United States, Pennsylvania
Lehigh Valley Health Network Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Don Park, MD    610-402-7880      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Boglarka Gyurkocza, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02677064    
Other Study ID Numbers: 16-024
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: January 24, 2022
Last Verified: January 2022
Keywords provided by Memorial Sloan Kettering Cancer Center:
Allogeneic Hematopoietic Stem Cell Transplantation
Identify Barriers
16-024
Additional relevant MeSH terms:
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Leukemia
Acute Disease
Neoplasms by Histologic Type
 Neoplasms
Disease Attributes
Pathologic Processes