NCT02303522

Brief Summary

An historical data comparator study for children with relapsed/refactory acute lymphoblastic leukemia (ALL).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

Geographic Reach
3 countries

3 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

First Submitted

Initial submission to the registry

November 6, 2014

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 1, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

December 9, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2015

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

1 month

First QC Date

November 6, 2014

Last Update Submit

May 4, 2020

Conditions

B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

Keywords

ALL, pediatric, leukemia, childhood, lymphoblastic, lymphoma, acute, Precursor Cell

Outcome Measures

Primary Outcomes (1)

  • Hematological Complete Remission (CR)

    To estimate hematological Complete Remission (CR) in pediatric patients with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (ALL)

    Approx. 1 year

Secondary Outcomes (5)

  • Overall survival

    Approx. 1 year

  • Molecular CR

    Approx. 1 year

  • Relapse Free Survival (RFS)

    Approx. 1 year

  • Time to hematological CR

    Approx. 1 year

  • Receipt of HSCT after salvage treatment

    Approx. 1 year

Study Arms (1)

All subjects

All subjects will be included in a unique cohort

Other: Other: not applicable - observational study

Interventions

Other: not applicable - observational studyOTHER

No intervention exists as this is a retrospective observational study

All subjects

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

You may qualify if:

  • Pediatric (age less than 18 years) patients with relapsed or refractory B-cell precursor ALL, specifically those with
  • nd or later relapse after chemotherapy (with no prior transplantation),
  • Relapse after HSCT, or
  • Refractory disease
  • Had treatment for relapsed or refractory disease between 2005-2012
  • Has data available on ALL treatment, including number of salvage treatments, response status after therapies, and HSCT

You may not qualify if:

  • No CNS involvement at relapse
  • No previous treatment with blinatumomab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Vienna, 1090, Austria

Location

Research Site

Berlin, 13353, Germany

Location

Research Site

Roma, 00165, Italy

Location

Related Links

MeSH Terms

Conditions

LeukemiaLymphoma

Condition Hierarchy (Ancestors)

Neoplasms 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 6, 2014

First Posted

December 1, 2014

Study Start

December 9, 2014

Primary Completion

January 22, 2015

Study Completion

January 22, 2015

Last Updated

May 6, 2020

Record last verified: 2020-05

Locations

IT(1)DE(1)AU(1)