An Study of Patients With Ph- Chromosome-negative Relapsed or Refractory Acute Lymphoblastic Leukemia in the US

Amgen

Status: Completed

Conditions: Relapsed/Refractory Acute Lymphoblastic Leukemia

Treatments: Other: Other

Study type: Observational

Funder types: Industry

Identifiers

NCT02783651

20150253

Details and patient eligibility

About

A retrospective chart review study of Philadelphia chromosome-negative R/R ALL patients in the US.

Enrollment: 212 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

212 participants in 2 patient groups

No treatment 1

Description:

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.

Treatment:

Other: Other

No Treatment 2

Description:

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.

Treatment:

Other: Other