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NCT Number: NCT02010931

Retrospective Analysis of Survival in Adult MRD Positive Acute Lymphoblastic Leukemia Patients

A retrospective analysis of historical data looking at relapse free survival and overall survival rates in adult philadelphia negative B-pre-cursor 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 (relapse free survival and overall survival) for adult patients who have philadelphia negative B-precursor acute lymphoblastic leukemia, and are in complete hematological remission with minimal residual disease.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with Philadelphia-negative B-Precursor Acute Lyphmoblastic Leukemia in complete hematological remission defined as less than 5% blasts in bone marrow after at least 3 intensive chemotherapy blocks (i.e. any standard or investigational regimen according to adult protocols as long as 3 age appropriate chemotherapy blocks were given, this also includes relapse treatment
  • detection of minimal residual disease (molecular failure or molecular relapse) at a level of greater than or equal to 10*(-4) by PCR or greater than or equal to 10*(-3) by flow cytometry at a reference lab
  • Age 15 or greater at time of initial diagnosis with acute lymphoblastic leukemia. For patients aged 15-17 treatment according to adult protocols is required
  • Initial diagnosis in the year 2000 or later
  • History of acute lymphoblastic leukemia treatment (including response to first therapy, number of prior relapses) is available
  • Relapse status and disease follow up after timepoint of minimal residual disease detection is available

Exclusion criteria

  • Patients with extramedullary disease at timepoint of minimal residual disease detection
  • Use of Blinatumomab within 18 months of minimal residual disease detection
  • Allogeneic hematopoietic stem cell transplantation prior to minimal residual disease detection at the required level

Treatment and study plan

Primary outcomes

  1. hematological relapse free survival

    Time frame: Approximately 18 months

    to estimate the hematological relapse free survival in patients who are 18 years or older, who have minimal residual disease detected by PCR at a level of 1/10-3 or higher, who are free form allogeneic stem cell transplantation until hematological relapse or until 18 months after minimal residual disease detection (whichever comes first)

Secondary outcomes

  1. hematological relapse free survival

    Time frame: Approximately 18 months

    to estimate the hematological relapse free survival in patients who are 15 years or older, who have minimal residual disease regardless of detection method, with or without stem cell transplantation within18 months of minimal residual disease detection

  2. overall survival

    Time frame: Approximately 18 months

    to estimate overall survival in the 2 sets of patients described in the primary outcome measure, and the first secondary outcome measure.

  3. mortality rate

    Time frame: 100 days following allogeniec stem cell transplantation

    to estimate the mortality rate (proportion) at 100 days following allogeneic stem cell transplantation in patients who received an allogeneic stem cell transplantation within 18 months after minimal residual disease detection

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

  • European EWALL study groups

Registry information

Official study title

A Retrospective Analysis of Hematological Relapse Free Survival and Overall Survival in Adult Patients With Philadelphia-Negative B-Precursor Acute Lymphoblastic Leukemia in Complete Hematological Remission With Minimal Residual Disease

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 13, 2013
Registry last updated
Sep 15, 2022

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

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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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