An Study of Patients With Ph- Chromosome-negative Relapsed or Refractory Acute Lymphoblastic Leukemia in the US
An Observational Study of Patients With Philadelphia Chromosome-negative Relapsed or Refractory Acute Lymphoblastic Leukemia in the US
1 other identifier
observational
212
1 country
19
Brief Summary
A retrospective chart review study of Philadelphia chromosome-negative R/R ALL patients in the US.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2016
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2016
CompletedFirst Posted
Study publicly available on registry
May 26, 2016
CompletedStudy Start
First participant enrolled
June 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedApril 27, 2020
April 1, 2020
3.8 years
May 11, 2016
April 24, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Treatment patterns in patients with Ph- R/R ALL
86 months
Drug utilization in patients with Ph- R/R ALL
86 months
Healthcare resource utilization in patients with Ph- R/R ALL
86 months
Secondary Outcomes (6)
Receipt of allogeneic stem cell transplantation following salvage treatment
86 Months
Incidence of selected adverse events including cytokine release syndrome, neurologic events, any events resulting in hospitalizations, and other serious adverse events.
86 Months
Best response to salvage treatment (chemotherapy or blinatumomab) within 8 weeks and within 12 weeks of initiation of salvage treatment.
12 Weeks
MRD status within 12 weeks of initiation of salvage treatment
12 Weeks
Overall survival from the time of initiation of salvage treatment
86 Months
- +1 more secondary outcomes
Study Arms (2)
No treatment 1
It is planned to have 20-30 sites participating on the trial for chart review of approximately 200-235 patients initiating treatment for Philadelphia chromosome-negative (Ph-) Relapsed or Refractory (R/R) Acute Lymphoblastic Leukemia (ALL) between January 2013 and March 2019.
No Treatment 2
Initial record abstraction will occur at study site with subsequent reviews occurring at the site every 3 months thereafter until study conclusion on March 2020.
Interventions
Eligibility Criteria
Patients initiating treatment for Philadelphia chromosome-negative (Ph-) R/R ALL between January 2013 and March 2019 at participating clinical sites in the US
You may not qualify if:
- Medical records of patients with Ph+ ALL will be excluded.
- If informed consent is required, medical records of patients who do not provide informed consent will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (19)
Research Site
Tucson, Arizona, 85719, United States
Research Site
Duarte, California, 91010, United States
Research Site
Los Angeles, California, 90089, United States
Research Site
Chicago, Illinois, 60612, United States
Research Site
Ames, Iowa, 50010, United States
Research Site
New Orleans, Louisiana, 70112, United States
Research Site
Baltimore, Maryland, 21201, United States
Research Site
Baltimore, Maryland, 21287, United States
Research Site
Detroit, Michigan, 48201, United States
Research Site
Hackensack, New Jersey, 07601, United States
Research Site
Buffalo, New York, 14263, United States
Research Site
New York, New York, 10065, United States
Research Site
Winston-Salem, North Carolina, 27157, United States
Research Site
Cincinnati, Ohio, 45229, United States
Research Site
Cleveland, Ohio, 44106, United States
Research Site
Philadelphia, Pennsylvania, 19104, United States
Research Site
Philadelphia, Pennsylvania, 19107, United States
Research Site
Austin, Texas, 78701, United States
Research Site
Seattle, Washington, 98109-1023, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2016
First Posted
May 26, 2016
Study Start
June 30, 2016
Primary Completion
March 31, 2020
Study Completion
March 31, 2020
Last Updated
April 27, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request