NCT02003612

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

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

Enrollment
2,373

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 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

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2014

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

3 months

First QC Date

December 2, 2013

Last Update Submit

November 4, 2022

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • hematological complete remission

    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)

    Approx 1 year

Secondary Outcomes (3)

  • overall survival

    Approx 1 year

  • duration of complete remission

    Approx 1 year

  • proportion of patients receiving allogeneic hematological stem cell transplantation

    Approx 1 year

Study Arms (1)

All subjects

All subjects

Other: Not applicable - observational study

Interventions

Not applicable - observational studyOTHER

No intervention exists as this is a retrospective observational study

All subjects

Eligibility Criteria

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

Adults with relapsed / refractory B-precursor acute lymphoblastic leukemia identified in study group databases from multiple sites in EU and US

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

Boston, Massachusetts, 02215, United States

Location

Research Site

Cleveland, Ohio, 44195, United States

Location

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

Venezia, 30174, Italy

Location

Research Site

Gliwice, 44-101, Poland

Location

Research Site

Badalona, Catalonia, 08916, Spain

Location

Research Site

London, NW3 2PF, United Kingdom

Location

Related Publications (2)

  • Barlev A, Lin VW, Katz A, Hu K, Cong Z, Barber B. Estimating Long-Term Survival of Adults with Philadelphia Chromosome-Negative Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia Treated with Blinatumomab Using Historical Data. Adv Ther. 2017 Jan;34(1):148-155. doi: 10.1007/s12325-016-0447-x. Epub 2016 Nov 21.

    PMID: 27873237DERIVED

  • Gokbuget N, Dombret H, Ribera JM, Fielding AK, Advani A, Bassan R, Chia V, Doubek M, Giebel S, Hoelzer D, Ifrah N, Katz A, Kelsh M, Martinelli G, Morgades M, O'Brien S, Rowe JM, Stieglmaier J, Wadleigh M, Kantarjian H. International reference analysis of outcomes in adults with B-precursor Ph-negative relapsed/refractory acute lymphoblastic leukemia. Haematologica. 2016 Dec;101(12):1524-1533. doi: 10.3324/haematol.2016.144311. Epub 2016 Sep 1.

    PMID: 27587380DERIVED

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

December 2, 2013

First Posted

December 6, 2013

Study Start

October 1, 2013

Primary Completion

January 10, 2014

Study Completion

April 28, 2014

Last Updated

November 7, 2022

Record last verified: 2022-11

Locations

IT(2)FR(1)PL(1)US(2)ES(1)CZ(1)DE(1)GB(1)