NCT03889951

Brief Summary

  1. 1.To detect IKZF-1 deletion mutations in patients with ALL.
  2. 2.To study the impact of IKZF-1 deletion mutation on therapy of ALL.
  3. 3.To study the correlation between IKZF-1 deletion mutations and BCR-ABL.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Status
unknown

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

February 28, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

February 28, 2019

Last Update Submit

March 25, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • detection of IKZF-1 deletion mutations in patients with ALL.

    detection of IKZF1 deletion mutation by fluorescent inset hybridization and by PCR.

    baseline

  • Detection of BCR-ABL translocation.

    by PCR

    baseline

Study Arms (2)

group 1

group of ALL patients with IKZF1 deletion mutation.

group 2

group of ALL patients with no detected mutation

Eligibility Criteria

Age1 Year - 70 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients newly diagnosed with acute lymphoblastic leukemia age ranged from 1 year to 70 years.

You may qualify if:

  • Patients with acute lymphoblastic leukemia.

You may not qualify if:

  • patients with any other hematological malignancies.
  • patients receiving chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Central Study Contacts

yasmin elgammal, Mac

CONTACT

alaa abdelkader, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 28, 2019

First Posted

March 26, 2019

Study Start

April 1, 2019

Primary Completion

April 1, 2020

Study Completion

May 1, 2020

Last Updated

March 26, 2019

Record last verified: 2019-03