Relapsed/Refractory Acute Lymphoblastic Leukemia Clinical Trial
Official title:
An Observational Study of Patients With Philadelphia Chromosome-negative Relapsed or Refractory Acute Lymphoblastic Leukemia in the US
| NCT number | NCT02783651 |
| Other study ID # | 20150253 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 30, 2016 |
| Est. completion date | March 31, 2020 |
| Verified date | April 2020 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
A retrospective chart review study of Philadelphia chromosome-negative R/R ALL patients in the US.
| Status | Completed |
| Enrollment | 212 |
| Est. completion date | March 31, 2020 |
| Est. primary completion date | March 31, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria -Medical records of patients initiating treatment for Ph- R/R ALL at participating clinical centers in the US between January 2013 and March 2019 will be eligible for inclusion. Exclusion Criteria - 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Ames | Iowa |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Buffalo | New York |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Detroit | Michigan |
| United States | Research Site | Duarte | California |
| United States | Research Site | Hackensack | New Jersey |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | New Orleans | Louisiana |
| United States | Research Site | New York | New York |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Treatment patterns in patients with Ph- R/R ALL | 86 months | ||
| Primary | Drug utilization in patients with Ph- R/R ALL | 86 months | ||
| Primary | Healthcare resource utilization in patients with Ph- R/R ALL | 86 months | ||
| Secondary | Receipt of allogeneic stem cell transplantation following salvage treatment | 86 Months | ||
| Secondary | Incidence of selected adverse events including cytokine release syndrome, neurologic events, any events resulting in hospitalizations, and other serious adverse events. | 86 Months | ||
| Secondary | Best response to salvage treatment (chemotherapy or blinatumomab) within 8 weeks and within 12 weeks of initiation of salvage treatment. | 12 Weeks | ||
| Secondary | MRD status within 12 weeks of initiation of salvage treatment | 12 Weeks | ||
| Secondary | Overall survival from the time of initiation of salvage treatment | 86 Months | ||
| Secondary | RFS from time remission achieved with salvage treatment | 86 Months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05832125 -
Registry of Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia
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