NCT02010931

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Shorter than P25 for all trials

Geographic Reach
8 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

November 25, 2013

Last Update Submit

September 12, 2022

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • hematological relapse free survival

    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)

    Approximately 18 months

Secondary Outcomes (3)

  • hematological relapse free survival

    Approximately 18 months

  • overall survival

    Approximately 18 months

  • mortality rate

    100 days following allogeniec stem cell transplantation

Study Arms (1)

primary

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)

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult acute lymphoblastic leukemia

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

Brno, 625 00, Czechia

Location

Research Site

Paris, 75475, France

Location

Research Site

Frankfurt am Main, 60590, Germany

Location

Research Site

Bologna, 40138, Italy

Location

Research Site

Roma, 00161, Italy

Location

Research Site

Venezia, 30174, Italy

Location

Research Site

Gliwice, 44-101, Poland

Location

Research Site

Moscow, 125167, Russia

Location

Research Site

Badalona, Catalonia, 08916, Spain

Location

Research Site

London, NW3 2PF, United Kingdom

Location

Related Publications (1)

  • Gokbuget N, Dombret H, Giebel S, Bruggemann M, Doubek M, Foa R, Hoelzer D, Kim C, Martinelli G, Parovichnikova E, Maria Ribera J, Schoonen M, Tuglus C, Zugmaier G, Bassan R. Blinatumomab vs historic standard-of-care treatment for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukaemia. Eur J Haematol. 2020 Apr;104(4):299-309. doi: 10.1111/ejh.13375. Epub 2020 Jan 24.

    PMID: 31876009BACKGROUND

Related Links

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2013

First Posted

December 13, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2014

Study Completion

June 1, 2014

Last Updated

September 15, 2022

Record last verified: 2022-09

Locations

GB(1)ES(1)FR(1)DE(1)PL(1)CZ(1)IT(3)RU(1)