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

Amgen logo

Amgen

Status

Completed

Conditions

Acute Lymphoblastic Leukemia

Study type

Observational

Funder types

Industry
Other

Identifiers

NCT02010931
20120148

Details and patient eligibility

About

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.

Full description

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.

Enrollment

310 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

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

Trial design

310 participants in 1 patient group

primary
Description:
subjects 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)

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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