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Completed

NCT Number: NCT02783651

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

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

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Key information

Conditions

Relapsed/Refractory Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

other

Other

No intervention other than routine medical care

Primary outcomes

  1. Treatment patterns in patients with Ph- R/R ALL

    Time frame: 86 months

  2. Drug utilization in patients with Ph- R/R ALL

    Time frame: 86 months

  3. Healthcare resource utilization in patients with Ph- R/R ALL

    Time frame: 86 months

Secondary outcomes

  1. Receipt of allogeneic stem cell transplantation following salvage treatment

    Time frame: 86 Months

  2. Incidence of selected adverse events including cytokine release syndrome, neurologic events, any events resulting in hospitalizations, and other serious adverse events.

    Time frame: 86 Months

  3. Best response to salvage treatment (chemotherapy or blinatumomab) within 8 weeks and within 12 weeks of initiation of salvage treatment.

    Time frame: 12 Weeks

  4. MRD status within 12 weeks of initiation of salvage treatment

    Time frame: 12 Weeks

  5. Overall survival from the time of initiation of salvage treatment

    Time frame: 86 Months

  6. RFS from time remission achieved with salvage treatment

    Time frame: 86 Months

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 26, 2016
Registry last updated
Apr 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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