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NCT Number: NCT02003612

Historical Data Analysis of Hematological Remission and Survival in Adults With R/R Acute Lymphoblastic Leukemia

A retrospective analysis of historical data looking at hematological remission and survival in adult relapsed / refractory B-precursor acute lymphoblastic leukemia patients.

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Key information

Conditions

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

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Brno, Czechia

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About this study

A retrospective observational study reviewing historical survival data (hematological remission and survival) for adult patients who have either relapsed or refractory B-precursor acute lymphoblastic leukemia. Data are aggregated across multiple countries and study sites in the EU and US

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients with relapsed / refractory B-precursor acute lymphoblastic leukemia
  • age 15 or older at time of de novo (initial) diagnosis of acute lymphoblastic leukemia
  • initial diagnosis of acute lymphoblastic leukemia in the year 1990 or later
  • No CNS involvement at relapse
  • No isolated extramedullary relapse
  • Other inclusion criteria may apply

Treatment and study plan

Not applicable - observational study

Other

No intervention exists as this is a retrospective observational study

Primary outcomes

  1. hematological complete remission

    Time frame: Approx 1 year

    To estimate the proportion of patients in hematological complete remission (CR) for R/R Philadelphia chromosome negative (Ph-) B-precursor ALL patients following relapse or salvage treatment, excluding patients with a first remission duration of >12 months in first salvage (ie, patients with late relapse in first salvage)

Secondary outcomes

  1. overall survival

    Time frame: Approx 1 year

    to estimate overall survival for relapsed / refractory philadelphia negative B-precursor acute lymphoblastic leukemia patients following salvage treatment, excluding patients with late relapse in first salvage

  2. duration of complete remission

    Time frame: Approx 1 year

    to estimate the duration of complete remission for philadelphia negative patients following treatment for relapsed / refractory B-precursor acute lymphoblastic leukemia, excluding patients with late relapse in first salvage

  3. proportion of patients receiving allogeneic hematological stem cell transplantation

    Time frame: Approx 1 year

    estimate the proportion of patients receiving allogeneic hematological stem cell transplantation for philadelphia negative patients following treatment for relapsed / refractory B-precursor acute lymphoblastic leukemia excluding those with late relapse in first salvage

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

An Analysis of Historical Data on Hematological Remission and Survival Among Adult Patients With Relapsed / Refractory B-Precursor Acute Lymphoblastic Leukemia

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2013
Registry last updated
Nov 7, 2022

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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