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Completed

NCT Number: NCT02303522

Historical Data Analysis of Complete Remission in Children With R/R Acute Lymphoblastic Leukemia (ALL)

An historical data comparator study for children with relapsed/refactory acute lymphoblastic leukemia (ALL).

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Key information

Conditions

B-cell Precursor Acute Lymphoblastic Leukemia (ALL) Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Vienna, Austria

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About this study

A retrospective observational study reviewing historical complete remission for pediatric patients who had either relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pediatric (age less than 18 years) patients with relapsed or refractory B-cell precursor ALL, specifically those with
  • 2nd or later relapse after chemotherapy (with no prior transplantation),
  • Relapse after HSCT, or
  • Refractory disease
  • Had treatment for relapsed or refractory disease between 2005-2012
  • Has data available on ALL treatment, including number of salvage treatments, response status after therapies, and HSCT

Exclusion criteria

  • No CNS involvement at relapse
  • No previous treatment with blinatumomab

Treatment and study plan

Other: not applicable - observational study

Other

No intervention exists as this is a retrospective observational study

Primary outcomes

  1. Hematological Complete Remission (CR)

    Time frame: Approx. 1 year

    To estimate hematological Complete Remission (CR) in pediatric patients with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (ALL)

Secondary outcomes

  1. Overall survival

    Time frame: Approx. 1 year

    OS following salvage therapy: defined as time to death.

  2. Molecular CR

    Time frame: Approx. 1 year

    Defined as MRD <10-4 measured either by PCR or flow cytometry.

  3. Relapse Free Survival (RFS)

    Time frame: Approx. 1 year

    Defined as time to relapse or death.

  4. Time to hematological CR

    Time frame: Approx. 1 year

    Defined as time to unequivocal detection of >5% leukemia cells in bone marrow as measured by cytological, microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia

  5. Receipt of HSCT after salvage treatment

    Time frame: Approx. 1 year

    Defined as the receipt of HSCT after chemotherapy or a previously failed HSCT.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Retrospective Pooled Analysis of Complete Remission Among Pediatric Patients With Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 1, 2014
Registry last updated
May 6, 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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